Non-Invasive Prediction of Colorectal Neoplasia (NIPCON)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Philadelphia Veterans Affairs Medical Center
Sponsor:
Information provided by (Responsible Party):
Martin Tobi, Philadelphia Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01815463
First received: March 18, 2013
Last updated: November 15, 2013
Last verified: November 2013
  Purpose

Hypothesis:The Adnab-9 antigen is a predictive biomarker in individuals at risk of developing colorectal neoplasia.

Study aim is to evaluate the potential of the Adnab-9 monoclonal antibody (MAb) as a marker of cancer risk in a population at increased risk for colorectal cancer (CRC). This marker would be compared to other current and emerging diagnostic methods. 2,800 Veterans would be recruited into the study. In phase 1, candidates would be defined as having increased CRC risk by a short questionnaire. Stool samples would be obtained and a semi-quantitative Adnab-9 antigen assay (ELISA) would be determined. Patients with differing high and low estimations of fecal Adnab-9 would undergo colonoscopy at which time other samples of effluent and colonic mucosa would be taken, and a detailed lifestyle and nutritional questionnaire would be completed. The characteristics of the Adnab-9 fecal test as a diagnostic test would be critically determined using the outcome of the colonoscopic and other test results. The patients will be contacted through the mail and by word of mouth. Informed consent will be obtained before the samples are obtained. The participants are clinically defined as high-risk and therefore screening colonoscopy would be likely performed in any event. A number of assays for Adnab-9 are feasible including slot-blot, Western blot, and ELISA. Other stool studies include conventional fecal occult blood tests (FOBT or FIT) that will be performed in tandem. The investigators therefore began this method of collection and obtained consent from over 2000 patients with a similar overall compliance rate with FOBT screening procedures to that reported previously of approximately 50%. Currently the study is no longer enrolling patients at the Detroit VA and is now finalizing data entry. Another 450 patients to be recruited at the Philadelphia VAMC.


Condition
Colonic Polyps
Polyposis Coli
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Invasive Prediction of Colorectal Neoplasia

Resource links provided by NLM:


Further study details as provided by Philadelphia Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Correlation of Adnab-9 stool result with outcome of colonoscopy [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Stool is collected on guaiac stool cards and/or stool Polymedco sample bottle and extracted. Extracted stool is assayed for protein content and this is used as a standard for the Adnab-9 ELISA. Record review note colonoscopy outcome which is correlated with Adnab-9 ELISA result.


Secondary Outcome Measures:
  • Define the origin of the Adnab-9 bound antigen [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Biopsies are taken at the time of colonoscopy in ~10% of initial enrollees, from 6 colonic segments. In addition colonic effluent. saliva, urine and blood samples are taken. ELISA and immunohistochemistry for Adnab-9 binding are performed.


Biospecimen Retention:   Samples With DNA

Stool Urine Saliva Blood Tissue


Estimated Enrollment: 2800
Study Start Date: August 2006
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
colorectal neoplasia
No interventions Record colorectal neoplasia

Detailed Description:

The primary objectives is to test the efficacy of Adnab-9 stool testing in a population at high-risk for colorectal neoplasia and directly compare it to that of the FOBT and secondarily, identify the source of the Adnab-9 antigen to determine influences of diet and environment on its expression. The design is a prospective cross sectional (Part 1) and a case-control longitudinal follow-up study (Part 2) using a brief questionnaire to assess risk for cancer in a total of 2800 Part I patients will be enrolled designed to achieve a database of high risk individuals and measure fecal Adnab-9 levels before a clinically indicated colonoscopy is performed. The patients submit 4 FOBT cards in a routine manner by mail, 3 are used for the FOBT and stool is extracted from the last card for the Adnab-9 ELISA which is reported as OD/5ug protein/well. 100 Part 2 enrollees are then selected on the basis of positive fecal Adnab-9 test candidates matched with a like number of patients with negative stool results who have had their initial colonoscopy and who will have a 5-year follow-up colonoscopy. Detailed Adnab-9 testing (immunohistochemical Adnab-9 binding; blood biomarker estimations and Adnab-9 Western blotting) will be performed on various bodily fluids to perfect the method of testing and completion of the detailed questionnaire to check for reproducibility and interim lifestyle changes in these participants.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Greater than average risk for colorectal neoplasia

Criteria

Inclusion Criteria:

  • ability to complete a consent form
  • must be at above average risk for colorectal neoplasia
  • physically able to undergo colonoscopy or barium enema

Exclusion Criteria:

  • Mentally handicapped
  • Physically infirm
  • Low risk for colorectal neoplasia
  • Pregnant individuals
  • Vulnerable populations
  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: NCT01815463

Contacts
Contact: Martin Tobi, MB,ChB 989 497 2500 ext 13934 Martin.Tobi@va.gov
Contact: John Lieb, MD 215 823 5800 ext 3514 John.Lieb@va.gov

Locations
United States, Pennsylvania
Philadelphia VAMC Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kyong-Mi Chang, MD    215-823-5800 ext 5893    Kyong-Mi.Chang@va.gov   
Contact: Eileen McCarthy-Dorsey    215 823 5800 ext 6029    Eileen.McCarthy-Dorsey@va.gov   
Sub-Investigator: David E Kaplan, MD,MSc         
Sub-Investigator: Yu-Xiao Yang, MD, MCE         
Principal Investigator: Fadi Antaki, MD         
Principal Investigator: John Lieb, MD         
Sponsors and Collaborators
Philadelphia Veterans Affairs Medical Center
Investigators
Principal Investigator: Martin Tobi, MB,ChB Philadelphia VAMC (WOC) Detroit VAMC (WOC) Saginaw VAMC
Principal Investigator: Fadi Antaki, MD Detroit VAMC
Principal Investigator: John Lieb, MD Philadelphia PVAMC
  More Information

Publications:
Responsible Party: Martin Tobi, MB ChB, Philadelphia Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01815463     History of Changes
Other Study ID Numbers: 00919, 0409000159
Study First Received: March 18, 2013
Last Updated: November 15, 2013
Health Authority: United States: Federal Government

Keywords provided by Philadelphia Veterans Affairs Medical Center:
stool
monoclonal antibody
Adnab-9
FOBT
FIT
iFOBT
colonoscopy
barium enema
flexible sigmoidoscopy

Additional relevant MeSH terms:
Neoplasms
Colonic Polyps
Colorectal Neoplasms
Adenomatous Polyposis Coli
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Adenomatous Polyps
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Colonic Neoplasms
Neoplastic Syndromes, Hereditary
Intestinal Polyposis
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on August 28, 2014