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NCT05237960 · ClinicalTrials.gov registry record · Phase 2
Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia
A Phase 2 study of Oral Leukoplakia and Erythroplakia, sponsored by University of Arizona.
- Active
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
- 10
- Study locations
NCT05237960 is a Phase 2 study of Oral Leukoplakia and Erythroplakia that is active but no longer recruiting, run by University of Arizona. The registered enrollment target is 34 participants, below the 42-participant average among 4 other Oral Leukoplakia trials with a reported enrollment target (19% lower). The trial reports 10 study locations across 10 states.
The verdict
NCT05237960, a Phase 2 study of Oral Leukoplakia and Erythroplakia, is active but no longer recruiting, sponsored by University of Arizona.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
- 10
- Study locations
Study Summary
This phase IIb trial tests whether metformin works in preventing oral cancer in patients with oral leukoplakia (white patches) or erythroplakia (red patches). Metformin is in a class of drugs called biguanides. Metformin helps to control the amount of glucose (sugar) in the blood. It decreases the amount of glucose patients absorb from food and the amount of glucose made by the liver. Metformin also increases the body's response to insulin, a natural substance that controls the amount of glucose in the blood. This trial may help researchers determine if metformin can stop changes in the mouth that are related to pre-cancer growths in the mouth.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Biopsy
- DRUG Placebo Administration
- DRUG Extended Release Metformin Hydrochloride
Study Locations (10)
Arizona
- University of Arizona Cancer Center-North Campus - Tucson
California
- UC San Diego Medical Center - Hillcrest - San Diego
Florida
- Moffitt Cancer Center - Tampa
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Louisiana
- Louisiana State University - Lafayette
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
Minnesota
- University of Minnesota/Masonic Cancer Center - Minneapolis
New York
- NYU College of Dentistry - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2023-01-12 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05237960
The ClinicalTrials.gov registry entry for NCT05237960 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 42-participant average among 4 other Oral Leukoplakia trials with a reported enrollment target (19% lower). The listed sponsor is University of Arizona, which has 349 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Oral Leukoplakia appearing as the primary indexed condition, and to 4 interventions - of which Biospecimen Collection is the first listed.
NCT05237960 reports 10 study locations spanning 10 distinct geographic areas - top geographies include Arizona, California, Florida.
Frequently Asked Questions
What is clinical trial NCT05237960 about?
NCT05237960 is a clinical study titled "Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia". This phase IIb trial tests whether metformin works in preventing oral cancer in patients with oral leukoplakia (white patches) or erythroplakia (red patches). Metformin is in a class of drugs called biguanides. Metformin helps to control the amount of glucose (sugar) in the blood. It decreases the a...
What is the current status of trial NCT05237960?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2023-01-12. Estimated completion is 2026-12.
What conditions does trial NCT05237960 study?
This clinical trial studies the following conditions: Oral Leukoplakia, Erythroplakia.
What interventions are being tested in trial NCT05237960?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Biopsy (PROCEDURE), Placebo Administration (DRUG), Extended Release Metformin Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT05237960?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05237960 being conducted?
This trial has 10 study locations across Arizona, California, Florida, Georgia, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.