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NCT05279690 · ClinicalTrials.gov registry record · Phase 1
Pilot Trial of Colchicine in Urothelial Cancer and Other Solid Tumors
A Phase 1 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT05279690 is a Phase 1 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 16 participants.
The verdict
NCT05279690, a Phase 1 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This open-label, non-randomized study aims to determine the anti-inflammatory effect of colchicine on the reduction of peripheral blood CRP in patients with solid tumors or localized urothelial cancer. There are two cohorts, which will enroll separately and parallelly. Cohort 1 will include two successive groups with advanced/recurrent solid tumors (15 patients will receive low-dose colchicine and 15 for high-dose colchicine) who will receive 14 days of colchicine. In Cohort 2, 15 patients with post-radical surgery for high-risk clinically localized urothelial cancer will be enrolled. They will receive one 28-day cycle of colchicine. The primary outcome, post-treatment decline in CRP level, a continuous measure, will be defined as the maximum percentage decline from baseline in post-treatment CRP value within two weeks of colchicine (Cohort 1) or one cycle of colchicine (cohort 2), where the baseline value is measured before any treatment is initiated.
Interventions
- DRUG Colchicine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2022-02-14 |
| Est. Completion | 2024-12-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05279690
The ClinicalTrials.gov registry entry for NCT05279690 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Colchicine is the first listed.
NCT05279690 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05279690 about?
NCT05279690 is a clinical study titled "Pilot Trial of Colchicine in Urothelial Cancer and Other Solid Tumors". This open-label, non-randomized study aims to determine the anti-inflammatory effect of colchicine on the reduction of peripheral blood CRP in patients with solid tumors or localized urothelial cancer. There are two cohorts, which will enroll separately and parallelly. Cohort 1 will include two succ...
What is the current status of trial NCT05279690?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2022-02-14. Estimated completion is 2024-12-16.
What interventions are being tested in trial NCT05279690?
The interventions under investigation include: Colchicine (DRUG).
Who is sponsoring clinical trial NCT05279690?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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