Trials / Withdrawn
WithdrawnNCT02042495
Endometrial Cancer Biomarker Changes Following Exposure to Metformin
A Clinical Trial to Evaluate Endometrial Cancer Biomarker Changes Following Exposure to the Insulin Sensitizer Metformin
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Jewish General Hospital · Academic / Other
- Sex
- Female
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The investigators will explore the chemopreventive role of metformin. The purpose of this study is to determine whether, among patients with endometrial cancer, treatment with the currently approved insulin sensitizing drug metformin increases or decreases pathway activation distal to the insulin receptor in endometrial cancer tissue. This is a phase IIa study of metformin to be used to the pre-operative period of women diagnosed with endometrial cancer by comparing their endometrial biopsy specimens taken at their initial visit and after 4-6 weeks of treatment of metformin on the day of their surgical staging.
Detailed description
Aim 1 To determine whether, among patients with endometrial cancer, treatment with the currently approved insulin sensitizing drug metformin increases or decreases pathway activation distal to the insulin receptor in endometrial cancer tissue. Aim II To compare specified biomarkers in each endometrial cancer patient before and after receiving metformin. Our goal is to compare the following biomarkers in each patient before and after metformin administration: Ki-67, TUNEL assay for apoptosis level, phosphor-AMPK, phosphor-IGF-1R, phosphor-IRS1, phospho-Akt, phospho-S6, phosphor-mTOR, pACC. All patients diagnosed with endometrial cancer presenting to the Jewish General Hospital for surgical treatment will be invited to participate.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Metformin |
Timeline
- Start date
- 2016-08-01
- Primary completion
- 2017-12-01
- First posted
- 2014-01-23
- Last updated
- 2016-08-30
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT02042495. Inclusion in this directory is not an endorsement.