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NCT01511653 · ClinicalTrials.gov registry record
Validation of Colon Biomarkers for the Early Detection of Colorectal Adenocarcinoma
A clinical trial, sponsored by University of Michigan.
- Completed
- Registry status
- 13,000
- Enrollment target
NCT01511653: Completed study, sponsored by University of Michigan.
NCT01511653 is a clinical trial that has completed, run by University of Michigan. The registered enrollment target is 13,000 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01511653 has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- 13,000 participants
- Enrollment target
Study Summary
The investigators are undertaking a multi-center, 13000 subject validation study of several biomarkers for early detection of colon cancer. There are stool based biomarkers and blood based biomarkers being validated in this study. The biomarkers will be compared with colonoscopy and with FIT (fecal immunohistochemistry) tests which are the current standards for colon cancer screening. This is an NCI-early Detection Research Network funded project. The population targeted for this study are those persons undergoing colonoscopy for screening. Prior to colonoscopy or even prepping for colonoscopy, subjects will provide blood and stool samples as well as specific data regarding their GI and general medical history and concomitant medications. If subjects are interested in participating, arrangements will be made to see them. The informed consent process will take place, blood will be obtained, data will be obtained, and the stool kit described and given to the subject to take home. Stool samples will be sent back to the University of Michigan using prepaid mailing labels.
Primary Outcome
Test the hypothesis that sensitivity of stool vimentin methylation and/ the blood based panel (serum galectin-3 ligand, CEA, methylated genes BCAT1/IKZF1, Hypomethylated LINE1 from circulating cell free DNA) when combined with fecal immunochemical testing (FIT) will significantly improve the sensitivity of FIT for the detection of colorectal adenocarcinoma, and maintain specificity greater than 0.80.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13,000 participants |
| Start Date | 2011-10 |
| Est. Completion | 2019-04 |
What the finished NCT01511653 record still lists
NCT01511653 is an observational study that tracks outcomes without assigning an intervention. Its 13,000 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT01511653 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01511653 about?
NCT01511653 is a clinical study titled "Validation of Colon Biomarkers for the Early Detection of Colorectal Adenocarcinoma". The investigators are undertaking a multi-center, 13000 subject validation study of several biomarkers for early detection of colon cancer. There are stool based biomarkers and blood based biomarkers being validated in this study. The biomarkers will be compared with colonoscopy and with FIT (fecal ...
What is the current status of trial NCT01511653?
This trial is currently completed. The enrollment target is 13,000 participants. The study started on 2011-10. Estimated completion is 2019-04.
Who is sponsoring clinical trial NCT01511653?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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