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NCT01815463 · ClinicalTrials.gov registry record
Non-Invasive Prediction of Colorectal Neoplasia
A clinical trial, sponsored by Corporal Michael J. Crescenz VA Medical Center.
- Terminated
- Registry status
- 2,282
- Enrollment target
NCT01815463: Clinical Trial study, sponsored by Corporal Michael J. Crescenz VA Medical Center.
NCT01815463 is a clinical trial that was terminated before completion, run by Corporal Michael J. Crescenz VA Medical Center. The registered enrollment target is 2,282 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01815463 was terminated before completion, sponsored by Corporal Michael J. Crescenz VA Medical Center.
- TERMINATED
- Registry status
- 2,282 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,282 participants |
| Start Date | 2006-08 |
| Est. Completion | 2014-08 |
Why NCT01815463 stopped before completion
NCT01815463 is an observational study that tracks outcomes without assigning an intervention. Its 2,282 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT01815463 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01815463 about?
NCT01815463 is a clinical study titled "Non-Invasive Prediction of Colorectal Neoplasia". 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 w...
What is the current status of trial NCT01815463?
This trial is currently terminated. The enrollment target is 2,282 participants. The study started on 2006-08. Estimated completion is 2014-08.
Who is sponsoring clinical trial NCT01815463?
This trial is sponsored by Corporal Michael J. Crescenz VA Medical Center, which has 13 total clinical trials registered on ClinicalTrials.gov.
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