Clinical trial · Observational
Non-Invasive Prediction of Colorectal Neoplasia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Local PI did not submit annual renewal, still active in Detroit, not recruiting.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Polyps | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Polyposis Coli | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- colorectal neoplasia
- description
- No interventions Record colorectal neoplasia
Primary outcomes (1)
- measure
- Correlation of Adnab-9 stool result with outcome of colonoscopy
- timeFrame
- 10 years
- description
- 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 outcomes (1)
- measure
- Define the origin of the Adnab-9 bound antigen
- timeFrame
- 10 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDTobi M, Prabhu S, Gage RE, Orr T, Lawson MJ. Colorectal cancer risk: the impact of evidence of a field effect of carcinogenesis on blinded diagnosis using an anti-adenoma antibody test performed on colonoscopic effluent. Dig Dis Sci. 2002 Feb;47(2):317-21. doi: 10.1023/a:1013713920805. PMID 11855547
- BACKGROUNDTobi M, Elitsur Y, Moyer MP, Halline A, Deutsch M, Nochomovitz L, Luk GD. Mucosal origin and shedding of an early colonic tumor marker defined by Adnab-9 monoclonal antibody. Scand J Gastroenterol. 1993 Dec;28(12):1025-34. doi: 10.3109/00365529309098304. PMID 8303203
- BACKGROUNDTobi M, Maliakkal B, Zitron I, Alousi M, Goo R, Nochomovitz L, Luk G. Adenoma-derived antibody, Adnab-9 recognizes a membrane-bound glycoprotein in colonic tissue and effluent material from patients with colorectal neoplasia. Cancer Lett. 1992 Oct 30;67(1):61-9. doi: 10.1016/0304-3835(92)90009-k. PMID 1423246