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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: Clinical Trial Phase 1 study, sponsored by Boston Medical Center.
NCT03013855 is a Phase 1 study that was terminated before completion, run by Boston Medical Center. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
For example, the percentage of positive standard FIT results that also have positive DRE FIT results, and the percentage of negative standard FIT results that also have negative DRE FIT results.
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 |
Why NCT03013855 stopped before completion
NCT03013855 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which FIT-SOC is the first listed.
NCT03013855 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03013855's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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