Ohio Colorectal Cancer Prevention Initiative (OCCPI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Ohio State University Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Heather Hampel, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01850654
First received: May 3, 2013
Last updated: May 21, 2014
Last verified: December 2013
  Purpose

The purpose of the Ohio Colorectal Cancer Prevention Initiative (OCCPI) is to reduce morbidity and mortality due to colorectal cancer (CRC) in the state of Ohio. By identifying individuals at high-risk for CRC (genetically predisposed) and providing screening recommendations for cancer risk reduction, the OCCPI will understand how to increase length of life and quality of life for those diagnosed with CRC in Ohio, as well as to better prevent CRC in others in Ohio.

Participants will have free tumor screening for Lynch syndrome, and may be eligible for free genetic testing and free genetic counseling as part of this study.


Condition Intervention
Lynch Syndrome
Colorectal Cancer
Genetic: LS tumor screening
Genetic: Genetic testing
Behavioral: Genetic Counseling
Other: Biorepository
Behavioral: Questionnaire

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Ohio Colorectal Cancer Prevention Initiative: Universal Screening for Lynch Syndrome

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Determine the Incidence of Hereditary Cancer Syndromes among Newly Diagnosed Colorectal Cancer Patients [ Time Frame: 18 months (initial assessment) ] [ Designated as safety issue: No ]
    Through tumor testing for Lynch syndrome and follow-up genetic testing for all patients with abnormal tumor testing and select patients with normal tumor testing (those diagnosed under age 50 and those at 50 or over with a first degree relative with colorectal or endometrial cancer).


Estimated Enrollment: 4000
Study Start Date: December 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Probands
Participants with colorectal or endometrial cancer.
Genetic: LS tumor screening
All participants with CRC or EC will have LS tumor screening (MSI, IHC, methylation if applicable).
Other Names:
  • MSI
  • IHC
  • Methylation
Genetic: Genetic testing

Next-generation sequencing panel of several genes that increase the risk for hereditary cancers including the LS genes (MLH1, MSH2, MSH6, PMS2, EPCAM), polyposis genes (MUTYH, APC), and others.

The following study participants will have free genetic testing:

  • CRC and EC study participants with unmethylated MSI-high (MSI-H) tumors
  • CRC and EC study participants with microsatellite stable (MSS) or MSI-low (MSI-L) tumors who have abnormal IHC results (MLH1 and PMS2 are absent) and they do not have methylation of the MLH1 promoter
  • CRC study participants diagnosed with CRC <50 years with normal tumor studies, regardless of family history
  • CRC study participants diagnosed with CRC ≥ 50 years with normal tumor studies AND a FDR with CRC or EC

At-risk relatives of the individuals found to have LS are eligible for free single site genetic testing.

Behavioral: Genetic Counseling

The participants found to have LS or another type of hereditary cancer will have free genetic counseling.

At-risk relatives of the individuals found to have LS are eligible for free genetic counseling.

Other: Biorepository
The biorepository is an optional part of the OCCPI. CRC and EC participants will contribute leftover tumor and blood samples, as well as a saliva sample. FDR of the CRC participants will contribute a saliva sample. The at-risk relatives of those found to have LS will contribute blood and saliva samples.
Behavioral: Questionnaire
First-degree relatives of the participants with CRC
The first-degree relatives of the CRC probands (participants with colorectal cancer).
Other: Biorepository
The biorepository is an optional part of the OCCPI. CRC and EC participants will contribute leftover tumor and blood samples, as well as a saliva sample. FDR of the CRC participants will contribute a saliva sample. The at-risk relatives of those found to have LS will contribute blood and saliva samples.
Behavioral: Questionnaire
At-risk relatives
The relatives of the participants found to have Lynch syndrome.
Genetic: Genetic testing

Next-generation sequencing panel of several genes that increase the risk for hereditary cancers including the LS genes (MLH1, MSH2, MSH6, PMS2, EPCAM), polyposis genes (MUTYH, APC), and others.

The following study participants will have free genetic testing:

  • CRC and EC study participants with unmethylated MSI-high (MSI-H) tumors
  • CRC and EC study participants with microsatellite stable (MSS) or MSI-low (MSI-L) tumors who have abnormal IHC results (MLH1 and PMS2 are absent) and they do not have methylation of the MLH1 promoter
  • CRC study participants diagnosed with CRC <50 years with normal tumor studies, regardless of family history
  • CRC study participants diagnosed with CRC ≥ 50 years with normal tumor studies AND a FDR with CRC or EC

At-risk relatives of the individuals found to have LS are eligible for free single site genetic testing.

Behavioral: Genetic Counseling

The participants found to have LS or another type of hereditary cancer will have free genetic counseling.

At-risk relatives of the individuals found to have LS are eligible for free genetic counseling.

Other: Biorepository
The biorepository is an optional part of the OCCPI. CRC and EC participants will contribute leftover tumor and blood samples, as well as a saliva sample. FDR of the CRC participants will contribute a saliva sample. The at-risk relatives of those found to have LS will contribute blood and saliva samples.
Behavioral: Questionnaire

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Newly diagnosed with colorectal adenocarcinoma (all stages) and have a resection at any hospital in Ohio between 1/1/2013 and 12/31/2014.

    • For individuals who have neoadjuvant treatment and show a complete response at resection, the tumor screening will be attempted on their original biopsy (even if it occurred in 2012) as long as their resection occurred between 1/1/2013 and 12/31/2014.
    • Many individuals with stage IV CRC will not have a resection; therefore, the tumor screening will be attempted on their original colon biopsy as long as their primary diagnosis occurred between 1/1/2013 and 12/31/2014. If only metastatic CRC is available on a biopsy (liver or lymph node metastases), tumor screening will be attempted on the metastatic tissue.
  2. Newly diagnosed with endometrial cancer (any histology except sarcoma) and have a resection between 1/1/2013 and 12/31/2014 at OSU only.
  3. All at-risk relatives of the participants found to have LS.
  4. First-degree relatives (parents, siblings and adult children ≥ 25 years of age) of the CRC participants who do not have LS.

Exclusion Criteria:

  1. Prisoners.
  2. Individuals who are under the age of 18.
  3. Individuals must have a primary colorectal or endometrial cancer, not a recurrence of a previous colorectal or endometrial cancer.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01850654

Contacts
Contact: Rachel Pearlman, MS, LGC 614-293-5740 Rachel.Pearlman@osumc.edu
Contact: Heather Hampel, MS, LGC 614-293-7240 Heather.Hampel@osumc.edu

Locations
United States, Ohio
Akron General Medical Center Recruiting
Akron, Ohio, United States, 44109
Contact: Cathy Farmer       Cathy.Farmer@akrongeneral.org   
Akron City/St. Thomas Hospital (Summa Health System) Recruiting
Akron, Ohio, United States, 44309
Contact: Joyce Neading       neadinja@summahealth.org   
Principal Investigator: Sameer Mahesh, MD         
Summa Barberton (Summa Health System) Recruiting
Barberton, Ohio, United States, 44203
Contact: Joyce Neading       neadinja@summahealth.org   
Principal Investigator: Sameer Mahesh, MD         
Aultman Hospital Recruiting
Canton, Ohio, United States, 44710
Contact: Janet Moore       jmoore@aultman.com   
Contact: Tinnelle Luck, MS       tluck@aultman.com   
Principal Investigator: Kisa Weeman, MD         
Mercy Medical Center Recruiting
Canton, Ohio, United States, 44708
Contact: Joan Edwards       Joan.Edwards@cantonmercy.org   
Contact: Linda Sims       Linda.Sims@cantonmercy.org   
Principal Investigator: Gregory Manson, MD         
Adena Health System Recruiting
ChillIcothe, Ohio, United States, 45601
Contact: Linda Kight       lkight@adena.org   
Principal Investigator: Philip Kuebler, MD         
Good Samaritan Hospital (TriHealth) Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Courtney Rice, MS, CGC       Courtney_Rice@trihealth.com   
Contact: Karen Hulesman, MS, CGC       Karen_Hulesman@trihealth.com   
Principal Investigator: Scott Kelley, MD         
Bethesda North Hospital (TriHealth) Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Courtney Rice, MS, CGC       Courtney_Rice@trihealth.com   
Contact: Karen Hulesman, MS, CGC       Karen_Hulesman@trihealth.com   
Principal Investigator: Scott Kelley, MD         
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Marla Prues       Marla.Prues@thechristhospital.com   
Principal Investigator: Ian Paquette, MD         
Fairview Hospital Recruiting
Cleveland, Ohio, United States, 44111
Contact: Brandie Leach       leachb@ccf.org   
MetroHealth Recruiting
Cleveland, Ohio, United States, 44109
Contact: Deb Strater       dstrater@metrohealth.org   
Principal Investigator: Timothy O'Brien, MD         
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Brandie Leach, MS, CGC       leachb@ccf.org   
Principal Investigator: Matthew Kalady, MD         
Grant Medical Center Recruiting
Columbus, Ohio, United States, 43215
Contact: Patti Dunn       pdunn@ohiohealth.com   
Contact: Angie Mulholland       amulhol2@ohiohealth.com   
Principal Investigator: Philip Kuebler, MD         
Mount Carmel East Hospital Recruiting
Columbus, Ohio, United States, 43213
Contact: Gretchen Gunderson       ggunderson@mchs.com   
Contact: Sue DeVictor       sdevictor@zangcenter.com   
Sub-Investigator: Karamjit Khanduja, MD         
Principal Investigator: Philip Kuebler, MD         
Mount Carmel West Hospital Recruiting
Columbus, Ohio, United States, 43222
Contact: Sue Devictor       sdevictor@zangcenter.com   
Contact: Gretchen Gunderson       ggunderson@mchs.com   
Principal Investigator: Philip Kuebler, MD         
Sub-Investigator: Karamjit Khanduja, MD         
Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States, 43214
Contact: Kelly Reynolds       KREYNOL2@ohiohealth.com   
Contact: Janet Harvey       jharvey@ohiohealth.com   
Principal Investigator: Philip Kuebler, MD         
Doctors Hospital Recruiting
Columbus, Ohio, United States, 43228
Contact: Janet Harvey       janet.harvey@ohiohealth.com   
Principal Investigator: Philip Kuebler, MD         
Summa Western Reserve (Summa Health System) Recruiting
Cuyahoga Falls, Ohio, United States, 44223
Contact: Joyce Neading       neadinja@summahealth.org   
Principal Investigator: Sameer Mahesh, MD         
Good Samaritan Hospital Dayton Recruiting
Dayton, Ohio, United States, 45415
Contact: Katherine Peyton       kpeyton@gshdayton.org   
Principal Investigator: Howard Gross, MD         
Miami Valley Hospital Recruiting
Dayton, Ohio, United States, 45409
Contact: Jane Boerger       mjboerger@mvh.org   
Contact: Elizabeth Koelker       eakoelker@mvh.org   
Principal Investigator: Howard Gross, MD         
Wright-Patterson Medical Center Recruiting
Dayton, Ohio, United States, 45433
Contact: Joyce Russo       joyce.russo@us.af.mil   
Kettering Medical Center Recruiting
Dayton, Ohio, United States, 45429
Contact: Krista Bensman       krista.bensman@khnetwork.org   
Contact: Brandi Palmer       brandi.palmer@khnetwork.org   
Principal Investigator: Howard Gross, MD         
Grady Memorial Hospital Recruiting
Delaware, Ohio, United States, 43015
Contact: Vickie Maggard       VMAGGARD@ohiohealth.com   
Contact: Michelle McKinney-Harris       mmckinne@ohiohealth.com   
Principal Investigator: Philip Kuebler, MD         
Blanchard Valley Health System Recruiting
Findlay, Ohio, United States, 45840
Contact: Christy Montgomery       cmontgomery@bvhealthsystem.org   
Contact: Shannon Kohls       skohls@bvhealthsystem.org   
Principal Investigator: Howard Gross, MD         
Wayne Healthcare Recruiting
Greenville, Ohio, United States, 45331
Contact: Jill Brown       jill.brown@waynehealthcare.org   
Fairfield Medical Center Recruiting
Lancaster, Ohio, United States, 43130
Contact: Lisa Stevens       lisas@fmchealth.org   
St. Rita's Medical Center Recruiting
Lima, Ohio, United States, 45801
Contact: Lois Gerding       lagerding@health-partners.org   
Marietta Memorial Hospital Recruiting
Marietta, Ohio, United States, 45750
Contact: Sheryl Corp       scorp@mhsystem.org   
Contact: Joanna Lupardus       jlupardus@mhsystem.org   
Principal Investigator: Philip Kuebler, MD         
St. Luke's Hospital (ProMedica) Recruiting
Maumee, Ohio, United States, 43537
Contact: Ginger Schwyn       ginger.schwyn@promedica.org   
Hillcrest Hospital Recruiting
Mayfield Heights, Ohio, United States, 44124
Contact: Brandie Leach       leachb@ccf.org   
Atrium Medical Center Recruiting
Middletown, Ohio, United States, 45005
Contact: Sandy Fletcher       slfletcher@atriummedcenter.org   
Contact: Caitlin Conaway       ccconaway@atriummedcenter.org   
Principal Investigator: Howard Gross, MD         
Knox Community Hospital Recruiting
Mount Vernon, Ohio, United States, 43050
Contact: Bethany Lee       bethany.lee@knoxcommhosp.org   
Principal Investigator: Philip Kuebler, MD         
Licking Memorial Hospital Recruiting
Newark, Ohio, United States, 43055
Contact: Kenita Keck       kkeck@lmhealth.org   
Contact: Michelle Majoy       mmajoy@lmhealth.org   
Principal Investigator: Philip Kuebler, MD         
Southern Ohio Medical Center Recruiting
Portsmouth, Ohio, United States, 45648
Contact: Jamie Arnett       arnettj@somc.org   
Principal Investigator: Philip Kuebler, MD         
Robinson Memorial (Summa Health System) Recruiting
Ravenna, Ohio, United States, 44266
Contact: Joyce Neading       neadinja@summahealth.org   
Principal Investigator: Sameer Mahesh, MD         
Springfield Regional Medical Center Recruiting
Springfield, Ohio, United States, 45504
Contact: Linda Blosser       blosserl@sorcc.org   
Contact: Chaundra Foss       fossc@sorcc.org   
Principal Investigator: Philip Kuebler, MD         
Flower Hospital (ProMedica Health System) Recruiting
Sylvania, Ohio, United States, 43560
Contact: Carissa Jock       Carissa.Jock@ProMedica.org   
Contact: Melanie Wheeler       Melanie.Wheeler@ProMedica.org   
Toledo Hospital (Promedica Health System) Recruiting
Toledo, Ohio, United States, 43606
Contact: Sue Mayer       Sue.Mayer@ProMedica.org   
Contact: Melanie Wheeler       Melanie.Wheeler@ProMedica.org   
Upper Valley Medical Center Recruiting
Troy, Ohio, United States, 45373
Contact: Heather Penwell       hmpenwell@uvmc.com   
Contact: Jean Heath       jaheath@uvmc.com   
Principal Investigator: Howard Gross, MD         
Mount Carmel St. Ann's Hospital Recruiting
Westerville, Ohio, United States, 43081
Contact: Gretchen Gunderson       ggunderson@mchs.com   
Contact: Sue DeVictor       sdevictor@zangcenter.com   
Principal Investigator: Philip Kuebler, MD         
Sub-Investigator: Karamjit Khanduja, MD         
Genesis Cancer Care Center (Genesis Healthcare System) Recruiting
Zanesville, Ohio, United States, 43701
Contact: Mary West       mwest@genesishcs.org   
Contact: Annette Barr       abarr@genesishcs.org   
Principal Investigator: Philip Kuebler, MD         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Heather Hampel, MS, LGC Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Heather Hampel, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01850654     History of Changes
Other Study ID Numbers: OSU-12170
Study First Received: May 3, 2013
Last Updated: May 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
colorectal cancer
colon cancer
rectal cancer
endometrial cancer
Lynch syndrome
Ohio colon cancer study
OSU colon study

Additional relevant MeSH terms:
Colorectal Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 28, 2014