Non-Invasive Prediction of Colorectal Neoplasia (NIPCON)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Non-Invasive Prediction of Colorectal Neoplasia|
- 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.
- 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
|Study Start Date:||August 2006|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
No interventions Record colorectal neoplasia
Please refer to this study by its ClinicalTrials.gov identifier: NCT01815463
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|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|