| 1 |
NCT02656134 |
Unknown † |
Small Bowel Endoscopic Evaluation in Familial Adenomatous Polyposis (FAP) |
- Familial Adenomatous Polyposis
|
- Procedure: Duodenoscopy and enteroscopy
- Genetic: Molecular analysis.
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Genetic profile in FAP patients
|
55 |
All |
15 Years to 65 Years (Child, Adult) |
NCT02656134 |
Small bowel profile in FAP |
|
March 2015 |
September 2016 |
December 2016 |
January 14, 2016 |
January 14, 2016 |
|
- University of Sao Paulo Medical School
Sao Paulo, Brazil
|
| 2 |
NCT00770991 |
Completed
Has Results |
Lyophilized Black Raspberries in Adults With Familial Adenomatous Polyposis (FAP) |
- Familial Adenomatous Polyposis
|
- Drug: Black raspberry (BRB) Slurry
- Drug: Black Raspberry (BRB) Suppositories
- Drug: Black Raspberry (BRB) Placebo Slurry
|
Interventional |
Phase 1 |
- The Cleveland Clinic
- Ohio State University Comprehensive Cancer Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Change From Baseline to End of Study in Number of Rectal Polyps
- Change in Burden of Rectal Polyps
- Apoptosis and Cell Proliferation Measured by Percent Difference in Staining.
|
34 |
All |
18 Years and older (Adult, Senior) |
NCT00770991 |
2003-34501-13965 |
|
December 2005 |
September 2008 |
December 2008 |
October 10, 2008 |
February 15, 2016 |
February 15, 2016 |
- Cleveland Clinic
Cleveland, Ohio, United States
|
| 3 |
NCT01483144 |
Active, not recruiting |
Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP) |
- Familial Adenomatous Polyposis
|
- Drug: Eflornithine plus Sulindac
- Drug: Eflornithine and Placebo
- Drug: Sulindac and Placebo
|
Interventional |
Phase 3 |
- Cancer Prevention Pharmaceuticals, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Delaying time to the 1st occurrence of any FAP-related event.
- presence or absence of an ODC polymorphism
- excretion of 4 urinary polyamines
|
171 |
All |
18 Years and older (Adult, Senior) |
NCT01483144 |
CPP-FAP-310 |
|
October 2013 |
April 2019 |
June 2019 |
December 1, 2011 |
August 3, 2017 |
|
- University of California San Diego
La Jolla, California, United States - Emory University
Atlanta, Georgia, United States - Dana Farber Cancer Institute
Boston, Massachusetts, United States - (and 14 more...)
|
| 4 |
NCT00248053 |
Withdrawn |
Use of Curcumin in the Lower Gastrointestinal Tract in Familial Adenomatous Polyposis Patients |
- Familial Adenomatous Polyposis
|
|
Interventional |
Phase 2 |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
|
- polyp number and size
- side effects and medication compliance
|
0 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT00248053 |
05-04-12-04 |
|
November 2005 |
June 2008 |
|
November 3, 2005 |
September 20, 2012 |
|
|
| 5 |
NCT02354560 |
Unknown † |
Erythromycin Treatment for Readthrough of APC Gene Stop Codon Mutation in Familial Adenomatous Polyposis-minors' Adjusted Version |
- FAP-Familial Adenomatous Polyposis
|
|
Interventional |
Phase 4 |
- michal roll
- Tel-Aviv Sourasky Medical Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Evaluation of changes in number of adenomas measured by upper endoscopy
- Evaluation of changes in size of adenomas measured by lower endoscopy
- Evaluation of changes in size of desmoid tumors
|
15 |
All |
10 Years to 17 Years (Child) |
NCT02354560 |
0377-14-TLV |
|
June 2015 |
December 2017 |
December 2017 |
February 3, 2015 |
February 3, 2015 |
|
|
| 6 |
NCT02175914 |
Unknown † |
Erythromycin Treatment for Readthrough of APC Gene Stop Codon Mutations in Familial Adenomatous Polyposis |
- FAP-Familial Adenomatous Polyposis
|
|
Interventional |
Phase 4 |
- michal roll
- Tel-Aviv Sourasky Medical Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Evaluation of changes in number and size of adenomas measured by upper endoscopy
- Evaluation of changes in number and size of adenomas measured by lower endoscopy
- CT and MRI imaging for desmoids
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT02175914 |
TASMC-10-RK-0519-CTIL |
|
June 2014 |
June 2015 |
June 2016 |
June 26, 2014 |
June 26, 2014 |
|
- Gastrointestinal malignancies department of gastroentrology & liver disease, Tel Aviv Medical Center
Tel Aviv, Israel
|
| 7 |
NCT03471403 |
Recruiting |
Cold Snare Polypectomy for Duodenal Adenomas in Familial Adenomatous Polyposis |
- Familial Adenomatous Polyposis
|
|
Observational |
|
- Western Sydney Local Health District
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Number of serious and non-serious adverse events
- Duration of endoscopic procedure
- Perforation (peri-procedure and delayed)
- (and 3 more...)
|
100 |
All |
18 Years to 99 Years (Adult, Senior) |
NCT03471403 |
HREC/17/WMEAD/20(5002) |
COPDA |
October 10, 2017 |
October 10, 2020 |
October 10, 2020 |
March 20, 2018 |
March 30, 2018 |
|
- Westmead Endoscopy Unit
Westmead, New South Wales, Australia
|
| 8 |
NCT02747862 |
Recruiting |
Non-Surgical Management of Attenuated and Deleterious (Classical) Familial Adenomatous Polyposis: A Long-term Surveillance Program |
- Attenuated Familial Adenomatous Polyposis
- Deleterious Familial Adenomatous Polyposis
|
|
Observational |
|
- M.D. Anderson Cancer Center
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Chart Review of Outcomes of Participants with Attenuated Familial Adenomatous Polyposis (AFAP) and Deleterious Familial Adenomatous Polyposis (FAP) Undergoing Endoscopic Surveillance
|
1500 |
All |
Child, Adult, Senior |
NCT02747862 |
DR08-0006 |
|
February 2008 |
February 2020 |
February 2020 |
April 22, 2016 |
January 17, 2018 |
|
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
| 9 |
NCT00927485 |
Completed |
Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP) |
- Familial Adenomatous Polyposis
|
- Drug: Calcumin (Curcumin)
- Other: Risk Factor Questionnaire
- Other: Blood samples
- (and 2 more...)
|
Interventional |
Not Applicable |
- University of Puerto Rico
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- To determine in a randomized, double-blinded, placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number, and polyp size in patients with FAP.
|
44 |
All |
21 Years to 85 Years (Adult, Senior) |
NCT00927485 |
Protocol A2210108-UPR |
|
November 2007 |
November 2016 |
December 2016 |
June 25, 2009 |
November 17, 2017 |
|
- University of Puerto Rico Comprehensive Cancer Center
San Juan, Puerto Rico
|
| 10 |
NCT01245816 |
Withdrawn |
A Trial of Low Dose Sulindac Combined With Eflornithine in Patients With Familial Adenomatous Polyposis (FAP) |
- Familial Adenomatous Polyposis
|
- Drug: Eflornithine plus Sulindac
- Drug: Eflornithine plus Placebo
- Drug: Sulindac plus Placebo
|
Interventional |
Phase 3 |
- Cancer Prevention Pharmaceuticals, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Efficacy of Eflornithine plus Sulindac compared to Eflornithine alone and Sulindac alone determined by change in the number of polyps 2 mm or greater in a defined focal area of the rectum or pouch at baseline and after completion of the study treatment.
- Change in number of polyps 2 mm or greater in the distal 10 cm of rectum or pouch.
- Qualitative change in overall colon/rectum/pouch polyp burden (number and size).
- Presence of high grade dysplasia or villous adenoma in any polyp resected.
|
0 |
All |
18 Years to 65 Years (Adult) |
NCT01245816 |
CPP FAP-301 |
|
March 2011 |
May 2013 |
June 2013 |
November 23, 2010 |
April 24, 2015 |
|
|
| 11 |
NCT01725490 |
Unknown † |
The Chemopreventive Effect of Metformin in Patients With Familial Adenomatous Polyposis: Double Blinded Randomized Controlled Study |
- Familial Adenomatous Polyposis
|
|
Interventional |
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- the mean percentage change of the number and size of polyps in colon and/or duodenum.
|
100 |
All |
20 Years to 65 Years (Adult) |
NCT01725490 |
4-2012-0491 |
|
November 2012 |
September 2015 |
September 2015 |
November 12, 2012 |
July 9, 2013 |
|
- Department of Internal Medicine, Yonsei University College of Medicine
Seoul, Korea, Republic of - Department of Internal Medicine, Yonsei University College of Medicine
Seoul, Korea, Republic of
|
| 12 |
NCT00641147 |
Completed
Has Results |
Curcumin in Treating Patients With Familial Adenomatous Polyposis |
- Familial Adenomatous Polyposis
|
- Drug: Curcumin
- Other: Laboratory Biomarker Analysis
- Other: Placebo
|
Interventional |
Phase 2 |
- National Cancer Institute (NCI)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Polyp Number
- Mean Polyp Size in mm
- Number of Participants With a Decrease in Polyp Burden at 12 Months
- (and 9 more...)
|
44 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT00641147 |
NCI-2013-00536
CDR0000592794
NA_00011821
1R01CA134620
R01CA134620
P30CA006973 |
|
October 2010 |
November 2016 |
November 30, 2016 |
March 24, 2008 |
September 29, 2017 |
September 29, 2017 |
- Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States - University of Puerto Rico
San Juan, Puerto Rico
|
| 13 |
NCT00151476 |
Terminated
Has Results |
Observational Familial Adenomatous Polyposis Registry Study In Patients Receiving Celecoxib Compared to Control Patients |
- Familial Adenomatous Polyposis (FAP)
|
- Drug: Celecoxib
- Other: Routine Medical Care
|
Observational |
|
|
Industry |
- Observational Model: Cohort
|
- Time From Ileorectal Anastomosis (IRA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IRA
- Time From Start of Study Follow-up to the Time of First Excisional Polypectomy of a Rectal Polyp Post IRA
- Time From Ileopouch Anal Anastomosis (IPAA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA
- (and 9 more...)
|
68 |
All |
12 Years and older (Child, Adult, Senior) |
NCT00151476 |
NQ4-00-02-012
A3191167 |
|
November 2004 |
November 2008 |
November 2008 |
September 9, 2005 |
March 9, 2010 |
March 4, 2010 |
- Pfizer Investigational Site
Cleveland, Ohio, United States - Pfizer Investigational Site
Toronto, Ontario, Canada - Pfizer Investigational Site
Hvidovre, Copenhagen, Denmark - Pfizer Investigational Site
Barcelona, Spain
|
| 14 |
NCT00525655 |
Active, not recruiting |
Multimedia Intervention in Patients With Familial Adenomatous Polyposis (FAP) |
- Familial Adenomatous Polyposis
- Colorectal Cancer
|
- Behavioral: Web-Based Multimedia Intervention
- Behavioral: Questionnaire
|
Interventional |
Not Applicable |
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Pilot Test FAP Website (Interviews)
- Participant Assessment of FAP Website (Questionnaire)
|
55 |
All |
13 Years to 24 Years (Child, Adult) |
NCT00525655 |
2006-1037
NCI-2011-02827
1R41CA126453-01A1 |
|
August 2007 |
February 2019 |
February 2019 |
September 6, 2007 |
May 16, 2017 |
|
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
| 15 |
NCT03095703 |
Recruiting |
Sirolimus and Familial Adenomatous Polyposis (FAP) |
- Adenomatous Polyposis Coli
|
|
Interventional |
Phase 2 |
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Size of intestinal polyps
- Number of participants with treatment-related adverse events
- Number of intestinal polyps
- (and 5 more...)
|
5 |
All |
18 Years and older (Adult, Senior) |
NCT03095703 |
NL55868.018.15 |
|
October 3, 2017 |
January 1, 2019 |
March 1, 2019 |
March 30, 2017 |
January 10, 2018 |
|
- Academic Medical Centre
Amsterdam, Noord-Holland, Netherlands
|
| 16 |
NCT02113202 |
Completed |
Molecular Fluorescence Endoscopy in Patients With Familial Adenomatous Polyposis, Using Bevacizumab-IRDye800CW |
- Adenomatous Polyposis Coli
|
- Drug: Bevacizumab-IRDye800CW
- Device: Near infrared fluorescence endoscopy platform
|
Interventional |
Phase 1 |
- University Medical Center Groningen
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Number of fluorescent adenomatous polyps during surveillance endoscopy using the near-infrared fluorescence endoscopy platform in patients with Familial Adenomatous Polyposis (FAP), after administration of the fluorescent tracer bevacizumab-IRDye800CW.
- Meassure the mean fluorescent intensity of the polyps during fluorescence endoscopy, resect the polyps and score VEGF intensity after immunohistochemistry for VEGF.
- Number of participants with Serious Adverse Events as a measure of safety and Tolerability.
- Measure the mean fluorescent intensity of adenomas and compare this between the three different dosing groups to determine the best tracer dose for the fluorescence endoscopy procedure.
|
17 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02113202 |
NL45148.042.13
2013-002490-22 |
FLUOFAP |
March 2014 |
October 2015 |
October 2015 |
April 14, 2014 |
January 11, 2016 |
|
- University Medical Center Groningen
Groningen, Netherlands
|
| 17 |
NCT00510692 |
Completed
Has Results |
Chemoprevention Trial in Familial Adenomatous Polyposis (FAP) Coli Using EPA |
- Familial Adenomatous Polyposis Coli
- FAP
|
- Drug: Eicosapentanoic Acid (EPA)
- Procedure: Endoscopy
- Procedure: Biopsies taken
- Drug: Placebo
|
Interventional |
Phase 2
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Absolute Change in the Number of Polyps Measured in a Focal Area of the Rectum.
- Percentage Change in the Number of Polyps Measured in the Defined Focal Area of the Rectum.
- Change in Global Rectal Polyp Burden.
- (and 2 more...)
|
58 |
All |
18 Years and older (Adult, Senior) |
NCT00510692 |
EPA/POL/03 |
|
November 2006 |
April 2008 |
April 2008 |
August 2, 2007 |
August 22, 2014 |
August 22, 2014 |
- The Polyposis Registry, St. Mark's Hospital,
Harrow, Middlesex, United Kingdom
|
| 18 |
NCT02961374 |
Recruiting |
Erlotinib Hydrochloride in Reducing Duodenal Polyp Burden in Patients With Familial Adenomatous Polyposis at Risk of Developing Colon Cancer |
- APC Gene Mutation
- Attenuated Familial Adenomatous Polyposis
- Familial Adenomatous Polyposis
|
- Drug: Erlotinib Hydrochloride
- Other: Laboratory Biomarker Analysis
|
Interventional |
Phase 2 |
- National Cancer Institute (NCI)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Mean percent change in duodenal polyp burden assessed by esophagogastroduodenoscopy
- Incidence of grade 2/3 adverse event (AE) rate assessed according to National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- Incidence of all adverse events assessed according to NCI CTCAE version 4.0
- (and 7 more...)
|
70 |
All |
18 Years to 69 Years (Adult, Senior) |
NCT02961374 |
NCI-2016-01674
N01-CN-2012-00042
MAY2016-07-01
N01CN00042
P30CA015083 |
|
October 27, 2017 |
September 1, 2019 |
September 1, 2019 |
November 11, 2016 |
April 19, 2018 |
|
- Mayo Clinic in Arizona
Scottsdale, Arizona, United States - University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States - Mayo Clinic
Rochester, Minnesota, United States - (and 5 more...)
|
| 19 |
NCT00585312 |
Terminated
Has Results |
Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP) |
- Adenomatous Polyposis Coli
|
- Drug: Celecoxib
- Drug: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- Time to Disease Progression
- Time to Treatment Failure
- Total Number of Colorectal Polyps
- Colorectal Polyp Burden
|
106 |
All |
10 Years to 17 Years (Child) |
NCT00585312 |
A3191193 |
CHIP |
September 2006 |
October 2013 |
October 2013 |
January 3, 2008 |
November 3, 2014 |
November 3, 2014 |
- Pfizer Investigational Site
Chicago, Illinois, United States - Pfizer Investigational Site
Ann Arbor, Michigan, United States - Pfizer Investigational Site
Omaha, Nebraska, United States - (and 40 more...)
|
| 20 |
NCT01187901 |
Completed
Has Results |
A Clinical Trial of COX and EGFR Inhibition in Familial Polyposis Patients |
- Adenomatous Polyposis Coli
|
- Drug: Erlotinib
- Drug: Sulindac
- Drug: Placebo A
- Drug: Placebo B
|
Interventional |
Phase 2 |
- University of Utah
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Prevention
|
- Change in Duodenal Polyp Burden From Baseline to 6 Months
- Change in Duodenal Polyp Burden From Baseline to 6 Months in Classic Familial Adenomatous Polyposis (FAP) Participants
- Change in Duodenal Polyp Burden From Baseline to 6 Months in Attenuated FAP Participants
- (and 3 more...)
|
92 |
All |
18 Years to 69 Years (Adult, Senior) |
NCT01187901 |
00039278
P01CA073992 |
FAPEST |
April 2010 |
June 2014 |
July 2014 |
August 24, 2010 |
June 17, 2016 |
June 17, 2016 |
- Huntsman Cancer Institute
Salt Lake City, Utah, United States
|
| 21 |
NCT00140894 |
Terminated |
A Study of Rofecoxib in Familial Adenomatous Polyposis (FAP) (0966-205)(TERMINATED) |
- Adenomatous Polyposis Coli
|
- Drug: MK0966; rofecoxib / Duration of Treatment: 24 weeks
- Drug: Comparator: placebo / Duration of Treatment: 24 weeks
|
Interventional |
Phase 4 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Number and average size of rectal polyps
- Safety and tolerability
- Number and average size of duodenal polyps
- Proportions of patients with improved overall colon rating
|
62 |
All |
18 Years and older (Adult, Senior) |
NCT00140894 |
0966-205
2005_052 |
|
March 1, 2003 |
|
|
September 1, 2005 |
September 29, 2017 |
|
|
| 22 |
NCT00319007 |
Unknown † |
Influence of Sulindac and Probiotics on the Development of Pouch Adenomas in Patients With Familial Adenomatous Polyposis |
- Adenomatous Polyposis Coli
|
- Drug: Sulindac (drug)
- Drug: VSL#3 (probiotic)
- Drug: Inulin (probiotic)
|
Interventional |
Phase 2 |
- Radboud University
- Dutch Cancer Society
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Pouch mucosal proliferation index at 0, 1 and 2 months
- Pouch mucosal apoptosis index at 0, 1 and 2 months
- Pouch mucosal Glutathione S transferases activity and isoenzyme levels at 0, 1 and 2 months
- (and 2 more...)
|
30 |
All |
16 Years and older (Child, Adult, Senior) |
NCT00319007 |
23266
KUN 2003-2911 |
|
April 2006 |
|
December 2006 |
April 27, 2006 |
August 10, 2007 |
|
- Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands
|
| 23 |
NCT03061591 |
Not yet recruiting |
Turmeric Supplementation on Polyp Number and Size in Patients With Familial Adenomatous Polyposis. |
- Familial Adenomatous Polyposis
- FAP
- FAP Gene Mutation
|
- Dietary Supplement: Wholistic Turmeric capsules
- Other: Placebo
|
Interventional |
Phase 2 |
- Tel-Aviv Sourasky Medical Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of polyps
- Size of polyps
- Histological apoptosis assays in frozen polyps and normal tissue (such as KI67, caspase 3 activity and COX-2 expression).
- (and 6 more...)
|
40 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT03061591 |
TASMC-15-RK-0601-CTIL |
|
April 2017 |
April 2018 |
April 2020 |
February 23, 2017 |
February 23, 2017 |
|
|
| 24 |
NCT00033371 |
Terminated
Has Results |
Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis |
- Colorectal Cancer
- Familial Adenomatous Polyposis
|
- Drug: Celecoxib
- Other: Placebo
- Drug: eflornithine
- (and 2 more...)
|
Interventional |
Phase 2 |
- National Cancer Institute (NCI)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percent Change in the Number of Polyps Greater Than or Equal to 2mm in Diameter in Focal Area(s) of the Colorectum
- Global Duodenal Polyp Burden
- Percent Change in Polyp Size in Focal Area(s) of the Colorectum
- (and 2 more...)
|
112 |
All |
18 Years to 65 Years (Adult) |
NCT00033371 |
NCI-2013-00844
N01-CN95040
CDR0000069278
NCI-P02-0219
ID00-109
P30CA016672
MDA-ID-00109
N01-CN-95040
N01CN95040 |
|
December 2001 |
April 2009 |
December 2014 |
January 27, 2003 |
February 15, 2017 |
February 4, 2015 |
- M D Anderson Cancer Center
Houston, Texas, United States
|
| 25 |
NCT03346980 |
Recruiting |
Endoscopic Evaluation of Duodenal Polyposis in Patients With Familial Adenomatous Polyposis (FAP) |
- Familial Adenomatous Polyposes
- Duodenal Polyposis
- Duodenal Cancer
|
- Diagnostic Test: Esophagogastroduodenoscopy
|
Observational |
|
- Copenhagen University Hospital, Hvidovre
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Inter-observer agreement of the Spigelman Score evaluated by expert endoscopists.
- Inter- and intra-observer agreement of the endoscopic sub-scores evaluated by expert endoscopists (the number of polyps and the size of these)
- Intra-observer agreement of Spigelman Score evaluated by expert endoscopists.
- Inter- and intra-observer agreement of the Spigelman Score and the endoscopic sub-scores evaluated by novices.
|
33 |
All |
Child, Adult, Senior |
NCT03346980 |
SPIGELMAN-VALIDATE |
|
December 1, 2017 |
December 1, 2019 |
December 1, 2019 |
November 20, 2017 |
January 25, 2018 |
|
- Copenhagen University Hospital Hvidovre
Hvidovre, Capital, Denmark
|
| 26 |
NCT00253812 |
Unknown † |
Adenoma Detection Rate:NBI, AFI, Chromoscopic or Standard Endoscopy |
- Familial Adenomatous Polyposis
|
- Procedure: flexible sigmoidoscopy
|
Interventional |
Not Applicable |
- London North West Healthcare NHS Trust
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: Single
- Primary Purpose: Diagnostic
|
- The primary outcome measure will be the mean number of adenomas detected on the blinded video review for each endoscopy
- Adenoma detection rate for each of the modalities compared with each other.
- Primary endoscopist adenoma count for each modality.
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT00253812 |
05ADR-88 |
|
November 2005 |
|
|
November 15, 2005 |
September 24, 2007 |
|
- Norht West London Hospitals NHS Trust
London, Middlesex, United Kingdom
|
| 27 |
NCT00134758 |
Unknown † |
Ursodeoxycholic Acid in the Treatment of Duodenal Adenomas in Familial Adenomatous Polyposis (FAP) Patients |
- Adenomatous Polyposis Coli, Familial
|
- Drug: Ursodeoxycholic acid
- Drug: Placebo
|
Interventional |
Phase 2
Phase 3 |
- Assistance Publique - Hôpitaux de Paris
- Axcan Pharma
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- SPIGELMAN severity score of duodenal lesion after 2 years of follow-up
- Cellular proliferation (Ki 67 and PCNA)
- Biliary acid profile
- Compliance to the treatment
|
90 |
All |
18 Years to 65 Years (Adult) |
NCT00134758 |
P030419
AOM 03041 |
|
October 2004 |
June 2009 |
October 2009 |
August 25, 2005 |
July 29, 2009 |
|
- Saint-Antoine Hospital
Paris, France
|
| 28 |
NCT00808743 |
Completed |
Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis |
- Familial Adenomatous Polyposis
- Duodenal Neoplasms
- Duodenal Polyps
|
- Drug: Celecoxib
- Drug: Ursodeoxycholic acid
- Drug: Placebo
|
Interventional |
Phase 2
Phase 3 |
- Radboud University
- Dutch Cancer Society
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- Change in number and size of duodenal adenomas (assessed directly and by evaluation of video and photographic material from endoscopic procedures)
- Cell proliferation, in normal mucosa and adenomas (if present)
- Biliary acid profile (if present)
|
37 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT00808743 |
RUN 2008-4198
ABR nr.: NL23569.091.08
CMO: 2008/148
EudraCT: 2008-003696-43 |
PreDuoFAP |
May 2009 |
July 2011 |
January 2013 |
December 16, 2008 |
May 16, 2013 |
|
- Academic Medical Center
Amsterdam, Netherlands - University Medical Center
Groningen, Netherlands - Leiden University Medical Center
Leiden, Netherlands - (and 2 more...)
|
| 29 |
NCT01604564 |
Recruiting |
Registry With Information About Colitis Ulcerosa and Familial Adenomatous Polyposis Patients |
- Colitis,Ulcerative
- Adenomatous Polyposis Coli
- Reservoir, Ileoanal
|
|
Observational |
|
- Universitaire Ziekenhuizen Leuven
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Evaluation of postoperatieve recovery
|
200 |
All |
Child, Adult, Senior |
NCT01604564 |
S-54228 |
KOPOF |
May 2012 |
December 2018 |
December 2019 |
May 23, 2012 |
July 29, 2016 |
|
- University Clinics Gasthuisberg
Leuven, Flemish Brabant, Belgium
|
| 30 |
NCT00503035 |
Active, not recruiting |
Molecular Targeting of 15-Lipoxygenase-1 (15-LOX-1) for Apoptosis Induction in Human Colorectal Cancers |
- Familial Adenomatous Polyposis
|
- Drug: Celecoxib
- Procedure: Colonoscopy Biopsy
|
Interventional |
Phase 2 |
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- 13-S-HODE, 15-LOX-1 primary product, levels (measured by ELISA assay)
|
40 |
All |
16 Years and older (Child, Adult, Senior) |
NCT00503035 |
DM02-592
NCI-2012-01522
1R01CA106577-01A1 |
|
August 2003 |
August 2019 |
August 2019 |
July 18, 2007 |
January 17, 2018 |
|
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
| 31 |
NCT03494543 |
Completed
New |
Endoscopic Papillectomy for Ampullary Adenomas |
- Ampullary Adenoma
- Familial Adenomatous Polyposis
|
- Procedure: Endoscopic Papillectomy
|
Observational |
|
- Arcispedale Santa Maria Nuova-IRCCS
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- technical success
- number of procedures to achieve technical success
- incidence of adverse events
- (and 2 more...)
|
62 |
All |
18 Years and older (Adult, Senior) |
NCT03494543 |
CORE001 |
Papillectomy |
January 1, 2005 |
December 31, 2015 |
December 31, 2017 |
April 11, 2018 |
April 12, 2018 |
|
|
| 32 |
NCT00685568 |
Completed |
Celecoxib in Preventing Colorectal Cancer in Young Patients With a Genetic Predisposition for Familial Adenomatous Polyposis |
- Colorectal Cancer
- Precancerous Condition
|
- Drug: celecoxib
- Other: placebo
|
Interventional |
Phase 1 |
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Double (Participant, Care Provider)
- Primary Purpose: Prevention
|
- Toxicity
- Aberrant crypt foci (ACF) and adenoma burden in the entire colorectum
- Elimination of the learning curve in a phase II/III trial
- (and 7 more...)
|
22 |
All |
10 Years to 14 Years (Child) |
NCT00685568 |
ID02-090
MDA-ID-02090
CDR0000596468 |
|
December 2002 |
November 2006 |
November 2006 |
May 28, 2008 |
November 20, 2012 |
|
- Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States - M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States - Texas Children's Hospital
Houston, Texas, United States - University of Texas Medical School at Houston
Houston, Texas, United States
|
| 33 |
NCT03333265 |
Recruiting |
Primary Chemoprevention of Familial Adenomatous Polyposis With Berberine Hydrochloride |
|
- Drug: 100mg Berberine hydrochloride
- Drug: 300mg Berberine hydrochloride
- Drug: Placebo Oral Tablet
|
Interventional |
Phase 2
Phase 3 |
- xiaohua li
- Xijing Hospital of Digestive Diseases
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Cumulative the numbers and diameters of those colorectal adenomas during Berberine hydrochloride or placebo treatment in patients with familial adenomatous polyposis
|
100 |
All |
18 Years to 65 Years (Adult) |
NCT03333265 |
XJLL 2016 017 |
|
September 1, 2017 |
August 31, 2020 |
December 31, 2020 |
November 6, 2017 |
November 6, 2017 |
|
- Xijing Hospital of Digestive Disease
Xi'an, Shaanxi, China
|
| 34 |
NCT01052376 |
Terminated |
Endomicrocancer: Confocal Endomicroscopy in Patients With High Risk of Colorectal Cancer |
- Inflammatory Bowel Disease (IBD)
- Familial Adenomatous Polyposis
|
- Device: Confocal endomicroscopy
|
Interventional |
Not Applicable |
- Nantes University Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Evaluate and validate CEM in terms of its ability to diagnose neoplastic lesions and to distinguish between normal and neoplastic mucosa in vivo, based on comparison between "optical biopsies" and standard histology.
|
73 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01052376 |
BRD08/6-A |
|
December 2008 |
|
January 2011 |
January 20, 2010 |
May 23, 2012 |
|
- CHU de Lille
Lille, France - Hôpital Saint Philibert
Lomme, France - Institut Paoli Calmettes
Marseille, France - (and 3 more...)
|
| 35 |
NCT00026468 |
Withdrawn |
Exisulind in Preventing Polyps in Patients With Familial Adenomatous Polyposis |
- Colorectal Cancer
- Small Intestine Cancer
|
|
Interventional |
Phase 2
Phase 3 |
- University of Utah
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Double
- Primary Purpose: Prevention
|
|
0 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT00026468 |
CDR0000069032
R01CA080852
P30CA042014
UUMC-IRB-5999-96
NCI-H01-0079 |
|
July 1999 |
July 1999 |
July 1999 |
January 27, 2003 |
July 24, 2013 |
|
|
| 36 |
NCT01173250 |
Completed |
Is Diverting Ileostomy Necessary in Stapled Ileoanal Pouch? |
- Ulcerative Colitis
- Familial Adenomatous Polyposis
|
- Procedure: adding diverting ileostomy
- Procedure: omitting diverting ileostomy
|
Interventional |
Not Applicable |
|
Other |
|
|
|
All |
Child, Adult, Senior |
NCT01173250 |
251068 |
|
|
|
|
August 2, 2010 |
August 16, 2010 |
|
|
| 37 |
NCT02374931 |
Active, not recruiting |
18F-FES PET/CT in Imaging Patients With Desmoid Tumors |
- Deep Fibromatosis/Desmoid Tumor
- Familial Adenomatous Polyposis
|
- Drug: F-18 16 Alpha-Fluoroestradiol
- Procedure: Positron Emission Tomography
- Procedure: Computed Tomography
- Other: Laboratory Biomarker Analysis
|
Interventional |
Early Phase 1 |
- Vanderbilt-Ingram Cancer Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Standard uptake value (SUV) measured as percent injected dose per cc
- IHC staining intensity in tissue samples
|
3 |
All |
18 Years and older (Adult, Senior) |
NCT02374931 |
VICC SAR 1458
NCI-2015-00081
P30CA068485 |
|
April 2015 |
July 2017 |
December 2018 |
March 2, 2015 |
April 11, 2018 |
|
- Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
|
| 38 |
NCT01002287 |
Terminated
Has Results |
An Evaluation of SprayShield in Reducing Post-Operative Adhesion Formation Following Major Open Abdominal Surgery |
- Ulcerative Colitis
- Familial Polyposis
|
- Device: SprayShield Adhesion Barrier System
- Procedure: Good Surgical Technique Alone
|
Interventional |
Not Applicable |
- Integra LifeSciences Corporation
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Prevention
|
- The Incidence of Adhesions, Defined as the Proportion of Subjects Presenting at the Follow-up Surgery (10-12 Weeks) With One or More Adhesions to the Midline Incision, Regardless of Extent and/or Severity.
- Severity of Adhesions
- Adhesion Involvement Along the Midline Incision (Percentage)
- Mobilization Time
|
11 |
All |
18 Years and older (Adult, Senior) |
NCT01002287 |
ABD-08-001 |
|
October 2009 |
October 2010 |
May 2011 |
October 27, 2009 |
November 20, 2014 |
January 29, 2014 |
- Covidien
Bedford, Massachusetts, United States
|
| 39 |
NCT01815463 |
Terminated |
Non-Invasive Prediction of Colorectal Neoplasia |
- Colonic Polyps
- Polyposis Coli
- Colorectal Cancer
|
|
Observational |
|
- Corporal Michael J. Crescenz VA Medical Center
|
U.S. Fed |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Correlation of Adnab-9 stool result with outcome of colonoscopy
- Define the origin of the Adnab-9 bound antigen
|
2282 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT01815463 |
00919
0409000159 |
NIPCON |
August 2006 |
August 2014 |
August 2014 |
March 21, 2013 |
September 27, 2016 |
|
- Philadelphia VAMC
Philadelphia, Pennsylvania, United States
|
| 40 |
NCT00663819 |
Terminated
Has Results |
Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses |
- Rectal Cancer
- Ulcerative Colitis
- Familial Adenomatous Polyposis
- Diverticulitis
|
- Device: GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement
- Procedure: Staple line without reinforcement
|
Interventional |
Not Applicable |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak
- Identify and Compare the Rate of Anastomotic Stenosis Associated With Circular Stapled Anastomoses Constructed With and Without CBSG.
- Determine the Rate of Significant Staple Line Hemorrhage With and Without the Use of CBSG in Circular Stapled Anastomoses
- Determine the Efficacy and Further Substantiate Safety of CBSG Used in Conjunction With Circular Staplers When Performing High-risk Colorectal, Coloanal, and Ileoanal Anastomoses.
|
258 |
All |
18 Years and older (Adult, Senior) |
NCT00663819 |
2008-109
CS150 |
|
April 2008 |
October 2012 |
October 2012 |
April 22, 2008 |
April 17, 2018 |
September 10, 2014 |
- University of South Alabama
Mobile, Alabama, United States - University of Southern California, Keck School of Medicine
Los Angeles, California, United States - University of South Florida-Cleveland Clinic Florida
Weston, Florida, United States - (and 13 more...)
|
| 41 |
NCT00844727 |
Terminated |
Coxib-inhibition of Duodenal Polyp Growth in FAP |
|
- Drug: Rofecoxib
- Drug: placebo
|
Interventional |
Phase 2
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
|
38 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT00844727 |
RH01/01 |
|
September 2003 |
April 2004 |
April 2004 |
February 16, 2009 |
July 6, 2011 |
|
- Dept of Medicine, Rikshospitalet
Oslo, Norway
|
| 42 |
NCT02198092 |
Recruiting |
Preliminary Evaluation of Septin9 in Patients With Hereditary Colon Cancer Syndromes |
- Familial Adenomatous Polyposis
- Map Syndrome
- Lynch Syndrome
- (and 2 more...)
|
- Other: Epi proColon Testing
|
Observational |
|
- University of Pennsylvania
- Epigenomics, Inc
|
Other / Industry |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Septin9 Plasma Levels
- Septin9 Plasma Levels Versus Polyps
- Pre- and Post-Colectomy Colonic Epithelial Cell Numbers
- Septin9 Levels Versus Circulating Colonic Epithelial Cell Numbers
|
46 |
All |
18 Years and older (Adult, Senior) |
NCT02198092 |
816593 |
Septin9 |
July 2014 |
August 2020 |
August 2020 |
July 23, 2014 |
February 7, 2018 |
|
- University of Pennsylvania
Philadelphia, Pennsylvania, United States
|
| 43 |
NCT02470416 |
Recruiting |
Prevalence of Small Bowel Polyps in Patients With Sporadic Duodenal Adenomas |
|
- Device: Small bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTD
|
Interventional |
Not Applicable |
- Western Sydney Local Health District
- Westmead hospital Westmead NSW 2145 Australia
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Number of participants with sporadic (ie not related to FAP or PJS) duodenal/ampullary adenomas
- Number of participants with presence and prevalence of colonic polyps
|
200 |
All |
Child, Adult, Senior |
NCT02470416 |
HREC/14/WMEAD/226(4028) |
SPIDA |
October 2015 |
July 2018 |
July 2018 |
June 12, 2015 |
November 14, 2017 |
|
- Westmead Hospital
Westmead, New South Wales, Australia
|
| 44 |
NCT01286662 |
Completed |
A Cohort Study of Patients Treated With Brachytherapy for Selected Desmoid Patients in Gardner Syndrome |
- Gardner Syndrome
- Colorectal Carcinoma
- Desmoid Tumor
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- mortality
- incidence of colorectal carcinoma
- Incidence of desmoid tumors
|
105 |
All |
Child, Adult, Senior |
NCT01286662 |
TriemliH |
|
January 1978 |
December 2010 |
December 2010 |
January 31, 2011 |
January 31, 2011 |
|
|
| 45 |
NCT01987518 |
Recruiting |
French Digestive Polyposis Cohorte Family Adenomatous Polyposis With APC and MYH Gene Mutations , Cowden's Disease With PTEN Gene Mutation, Peutz Jeghers Disease With STK 11 Gene Mutation ,juvénil Polyposis With SMAD 4 Gene Mutation , Serrated and Hyperplastic Polyposis |
|
- Other: Procedure surgery behavioral and genetic diagnosis
- Procedure: quality of life after different type of surgery
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- genetic diagnosis or over 50 polyps in the stomach in the duodenum or in the colon
|
350 |
All |
12 Years to 90 Years (Child, Adult, Senior) |
NCT01987518 |
Peps Data Base
SISRA |
|
January 2011 |
August 2014 |
August 2020 |
November 19, 2013 |
February 28, 2018 |
|
- Hopital Edouard Herriot
Lyon, Rhone Alpes, France
|
| 46 |
NCT03027401 |
Not yet recruiting |
Clinical Sequencing of Cancer and Tissue Repository: OncoGenomics |
- Neoplasms
- Adenomatous Polyposis Coli
- Neurofibroma, Plexiform
- Myelodysplastic Syndromes
|
|
Observational |
|
- National Cancer Institute (NCI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Identify incidental and secondary findings in germline DNA and actionable somatic mutations for reporting clinical results from a CLIA-certified lab into CRIS medical records.
- Molecular, genomic, epigenetic, transcriptomic, proteomic, metabolomics and other "omics" profiling on tumors, malignancies and normal tissues
- Create a tissue repository
- (and 6 more...)
|
5000 |
All |
up to 99 Years (Child, Adult, Senior) |
NCT03027401 |
170040
17-C-0040 |
|
January 10, 2017 |
August 1, 2035 |
August 1, 2035 |
January 23, 2017 |
February 14, 2018 |
|
- National Institutes of Health Clinical Center
Bethesda, Maryland, United States
|
| 47 |
NCT03050268 |
Recruiting |
Familial Investigations of Childhood Cancer Predisposition |
- Acute Leukemia
- Adenomatous Polyposis
- Adrenocortical Carcinoma
- (and 43 more...)
|
|
Observational |
|
- St. Jude Children's Research Hospital
|
Other |
- Observational Model: Family-Based
- Time Perspective: Prospective
|
- Identification of novel cancer predisposing genes
|
3000 |
All |
Child, Adult, Senior |
NCT03050268 |
SJFAMILY |
SJFAMILY |
April 6, 2017 |
March 31, 2037 |
March 31, 2037 |
February 10, 2017 |
January 5, 2018 |
|
- St. Jude Children's Research Hospital
Memphis, Tennessee, United States
|
| 48 |
NCT01656746 |
Completed |
Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease |
- Adenomatous Polyp
- Crohn Disease
- Familial Adenomatous Polyposis
- (and 9 more...)
|
- Procedure: therapeutic laparoscopic surgery
|
Interventional |
Not Applicable |
- Ohio State University Comprehensive Cancer Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Operative time
- Length of skin and fascial incisions
- Estimated blood loss
- (and 5 more...)
|
10 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT01656746 |
OSU-09123
NCI-2012-00604 |
|
May 2010 |
October 2013 |
October 2013 |
August 3, 2012 |
December 6, 2017 |
|
- Ohio State University Medical Center
Columbus, Ohio, United States
|
| 49 |
NCT02012699 |
Recruiting |
Integrated Cancer Repository for Cancer Research |
- Pancreatic Cancer
- Thyroid Cancer
- Lung Cancer
- (and 44 more...)
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Development and implementation of a web-based Cancer Collaborative Registry at the University of Nebraska Medical Center (UNMC)/Nebraska Medical Center (NMC)
- Procurement and banking of excess biological material for future analysis
|
9999 |
All |
19 Years to 110 Years (Adult, Senior) |
NCT02012699 |
UNMC 253-13 |
iCaRe2 |
November 2013 |
December 2099 |
December 2099 |
December 16, 2013 |
May 9, 2017 |
|
- University of Alabama Birmingham
Birmingham, Alabama, United States - Penrose Cancer Center
Colorado Springs, Colorado, United States - Halifax Health Medical Center d/b/a Halifax Health
Daytona Beach, Florida, United States - (and 67 more...)
|
| 50 |
NCT00813241 |
Completed |
A Pilot Open-Label Crossover Bioavailability Study of Celecoxib in Healthy Volunteers |
|
- Drug: celecoxib reference formulation
- Drug: celecoxib test formulation A1
- Drug: celecoxib test formulation B2
- Drug: celecoxib test formulation C1
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
|
- PK endpoints will include Cmax, C12h, Tmax, AUCtlqc, AUCinf, and half-life (t1/2) for each formulation as data permit
- Visual inspection of median plasma concentration versus time profiles resulting from each formulation
- Adverse events and safety laboratory tests
|
16 |
All |
21 Years to 55 Years (Adult) |
NCT00813241 |
A3191354 |
|
January 2009 |
March 2009 |
March 2009 |
December 23, 2008 |
March 2, 2010 |
|
- Pfizer Investigational Site
Singapore, Singapore
|
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