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NCT03013855 · ClinicalTrials.gov registry record · Phase 1
Efficacy of Fecal Immunochemical Test Using Digital Rectal Exam
A Phase 1 study, sponsored by Boston Medical Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT03013855 is a Phase 1 study that was terminated before completion, run by Boston Medical Center. The registered enrollment target is 1 participants.
The verdict
NCT03013855, a Phase 1 study, was terminated before completion, sponsored by Boston Medical Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
This study will investigate the use of digital rectal exam (DRE) to obtain stool samples for the fecal immunochemical test (FIT) in patients due for screening colonoscopy and in pre-operative patients with known colorectal cancer. FIT is currently FDA-approved for spontaneous stool and DRE, however, samples are not commonly obtained by DRE. In addition, some clinicians remain skeptical about the accuracy of FIT using stool obtained from DRE. This study aims to assess the correlation between FIT using the stool sample from DRE (FIT-DRE) and standard of care FIT (FIT-SOC). If good correlation is shown, the investigators may be able to demonstrate efficacy of FIT using a DRE in the clinic setting. This may help avoid logistical barriers, as well as improve compliance and adherence to colon cancer screening in the outpatient setting, eventually leading to improved quality of care.
Interventions
- DEVICE FIT-SOC
- DEVICE FIT-DRE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2016-07 |
| Est. Completion | 2017-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03013855
The ClinicalTrials.gov registry entry for NCT03013855 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which FIT-SOC is the first listed.
NCT03013855 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03013855 about?
NCT03013855 is a clinical study titled "Efficacy of Fecal Immunochemical Test Using Digital Rectal Exam". This study will investigate the use of digital rectal exam (DRE) to obtain stool samples for the fecal immunochemical test (FIT) in patients due for screening colonoscopy and in pre-operative patients with known colorectal cancer. FIT is currently FDA-approved for spontaneous stool and DRE, however,...
What is the current status of trial NCT03013855?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2016-07. Estimated completion is 2017-07.
What interventions are being tested in trial NCT03013855?
The interventions under investigation include: FIT-SOC (DEVICE), FIT-DRE (DEVICE).
Who is sponsoring clinical trial NCT03013855?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
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