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NCT04094675 · ClinicalTrials.gov registry record · Phase 2
Sirolimus for Cowden Syndrome With Colon Polyposis
A Phase 2 study, sponsored by Ohio State University.
- Completed
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT04094675: Completed Phase 2 study, sponsored by Ohio State University.
NCT04094675 is a Phase 2 study that has completed, run by Ohio State University. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04094675, a Phase 2 study, has completed, sponsored by Ohio State University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
Colon polyposis (the presence of multiple colon polyps) is very common with Cowden syndrome, as over 60% of patients have 50 or more polyps. In a previous clinical trial, some participants had reduction in the number of colon polyps with the use of the medication sirolimus for a very short time period. This study is investigating sirolimus and its effect on the number of colon polyps in patients with Cowden syndrome and polyposis over a 1 year period.
Primary Outcome
Assessment of change in number of colon polyps. This will be assessed for each segment of colon (ascending, transverse, descending, sigmoid, rectum) and then aggregated into a total number of colon polyps. The entrance result will be compared to the final result for each participant.
Interventions
- DRUG Sirolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2019-09-16 |
| Est. Completion | 2025-06-05 |
| Phase | Phase 2 |
What the finished NCT04094675 record still lists
NCT04094675 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Sirolimus is the first listed.
NCT04094675 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04094675 about?
NCT04094675 is a clinical study titled "Sirolimus for Cowden Syndrome With Colon Polyposis". Colon polyposis (the presence of multiple colon polyps) is very common with Cowden syndrome, as over 60% of patients have 50 or more polyps. In a previous clinical trial, some participants had reduction in the number of colon polyps with the use of the medication sirolimus for a very short time peri...
What is the current status of trial NCT04094675?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2019-09-16. Estimated completion is 2025-06-05.
What interventions are being tested in trial NCT04094675?
The interventions under investigation include: Sirolimus (DRUG).
Who is sponsoring clinical trial NCT04094675?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04094675's enrollment target sits among peer trials
5 2000th of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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