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ACTIVE NOT RECRUITING Phase 2

Metformin Hydrochloride in Preventing Oral Cancer in Patients With an Oral Premalignant Lesion

NCT02581137 · View on ClinicalTrials.gov ↗

Study Summary

This phase IIa trial studies how well metformin hydrochloride works in preventing oral cancer in patients with an oral premalignant lesion (oral leukoplakia or erythroplakia). Oral premalignant lesions look like red or whitish plaques or lesions in the mouth that do not rub off and can be associated with a higher risk of cancer. Metformin hydrochloride may help prevent oral cancer from forming in patients with an oral premalignant lesion.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG Metformin Hydrochloride

Study Locations (4)

British Columbia

  • BC Cancer Research Centre — Vancouver
  • University of British Columbia Hospital — Vancouver

California

  • UC San Diego Medical Center - Hillcrest — San Diego

Minnesota

  • University of Minnesota/Masonic Cancer Center — Minneapolis

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2016-06-10
Est. Completion 2026-12-19
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02581137

The ClinicalTrials.gov registry entry for NCT02581137 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Oral Leukoplakia appearing as the primary indexed condition, and to 2 interventions — of which Laboratory Biomarker Analysis is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02581137 reports 4 study locations spanning 3 distinct geographic areas — top geographies include British Columbia, California, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02581137 about?

NCT02581137 is a clinical study titled "Metformin Hydrochloride in Preventing Oral Cancer in Patients With an Oral Premalignant Lesion". This phase IIa trial studies how well metformin hydrochloride works in preventing oral cancer in patients with an oral premalignant lesion (oral leukoplakia or erythroplakia). Oral premalignant lesions look like red or whitish plaques or lesions in the mouth that do not rub off and can be associated...

What is the current status of trial NCT02581137?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2016-06-10. Estimated completion is 2026-12-19.

What conditions does trial NCT02581137 study?

This clinical trial studies the following conditions: Oral Leukoplakia, Oral Cavity Carcinoma, Erythroplakia, Hyperplasia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02581137?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Metformin Hydrochloride (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02581137?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02581137 being conducted?

This trial has 4 study locations across California, Minnesota, British Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial