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NCT01205672 · ClinicalTrials.gov registry record · Early Phase 1
Evaluation of the Molecular Effects of Metformin on the Endometrium in Patients With Endometrial Cancer
A Early Phase 1 study of Endometrial Cancer, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 21
- Enrollment target
- 2
- Study locations
NCT01205672: Completed Early Phase 1 study of Endometrial Cancer, sponsored by M.D. Anderson Cancer Center.
NCT01205672 is a Early Phase 1 study of Endometrial Cancer that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 21 participants, below the 524-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01205672, a Early Phase 1 study of Endometrial Cancer, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 21 participants
- Enrollment target
- 2
- Study locations
Study Summary
The goal of this research study is to learn if metformin can affect endometrial cancer cells in women who do not have diabetes. Objectives: Primary Objectives: 1\. To determine the molecular effects of metformin and associated physiologic changes in insulin/glucose metabolism on the mTOR (mammalian target of rapamycin) signaling pathway in the endometrium of women with endometrial cancer Secondary Objectives: 1. To describe the effects of metformin on the histology and proliferation of the endometrium in women with endometrial cancer. 2. To assess the effect of body mass index on the response to treatment with metformin 3. To assess the effect of insulin resistance on the response to treatment with metformin 4. To determine effects of metformin on the serum, urine and DNA biomarkers of women with endometrial cancer.
Primary Outcome
Baseline expression of s6K measured using Western blots, which yield ordinal results (e.g. "weak", "moderate", "strong", etc.). After treatment with metformin, expression again observed, and the percent of patients who have an increase in expression will be calculated.
Conditions Studied
Interventions
- DRUG Metformin
Study Locations (2)
Texas
- Lyndon B. Johnson General Hospital - Houston
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2010-09-16 |
| Est. Completion | 2017-05-28 |
| Phase | Early Phase 1 |
What the finished NCT01205672 record still lists
NCT01205672 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 524-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Endometrial Cancer appearing as the primary indexed condition, and to 1 intervention - of which Metformin is the first listed.
NCT01205672 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01205672 about?
NCT01205672 is a clinical study titled "Evaluation of the Molecular Effects of Metformin on the Endometrium in Patients With Endometrial Cancer". The goal of this research study is to learn if metformin can affect endometrial cancer cells in women who do not have diabetes. Objectives: Primary Objectives: 1\. To determine the molecular effects of metformin and associated physiologic changes in insulin/glucose metabolism on the mTOR (mammali...
What is the current status of trial NCT01205672?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 21 participants. The study started on 2010-09-16. Estimated completion is 2017-05-28.
What conditions does trial NCT01205672 study?
This clinical trial studies the following conditions: Endometrial Cancer.
What interventions are being tested in trial NCT01205672?
The interventions under investigation include: Metformin (DRUG).
Who is sponsoring clinical trial NCT01205672?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01205672 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Endometrial Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01205672's enrollment target sits among peer trials
21 166th of 181 higher than 12 of 181 other Endometrial Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Endometrial Cancer 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.
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