Clinical trial NCT05192850: Endometrial Cancer Recurrence in Patients Taking Metformin
Official title: Endometrial Cancer Recurrence in Patients Taking Metformin
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Recurrent Endometrial Carcinoma
Keywords: metformin
endometrial cancer
Lead sponsor: WellSpan Health
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who underwent initial treatment for curative intent of endometrial cancer in the WellSpan system between 2016-2020

Brief summary: Given the early literature available and its biological plausibility as an inhibitor of the mammalian target of rapamycin (mTOR) protein, it is hypothesized that women with endometrial cancer who take metformin for non-cancer related reasons have a lower cancer recurrence rate compared to women not taking metformin. The primary goal of this study is to determine whether metformin use is associated with a decrease in the rate of endometrial cancer recurrence. Secondary objectives are to assess whether women with endometrial cancer taking metformin have longer progression free survival and overall survival than those that do not take metformin.

Detailed description: This is a retrospective chart review study. Medical records are reviewed and data collected through the hospital's electronic medical record (EMR). Participants are women that had definitive treatment for endometrial cancer between 2016-2020 at WellSpan York Hospital Department of Gynecologic Oncology. Participants are identified and their chart reviewed for demographic data of age, race, comorbid conditions, and use of metformin. Possible confounding information is documented, including chemotherapy status, radiotherapy status, cancer and tumor type, grade, and stage, available genetics information, medications at the time of cancer diagnosis, and medication durations. Those patients who had cancer recurrence are identified. Recurrence data including type, time interval, additional treatment are collected. Recurrence is defined as any recurrence validated by clinical, imaging and histological data and can be identified based on the cancer registry. Recurrence rate in participants that took metformin vs. those that did not is calculated. Time to endometrial cancer recurrence is calculated. Progression free survival and overall survival are calculated. Statistical analysis is performed to compare each of these outcomes between participants who took metformin vs. those that did not.

Eligibility criteria: Inclusion Criteria:

* Participants with endometrial cancer of all histologies treated in the WellSpan system from 2016-2020

Exclusion Criteria:

* Participants who underwent palliative treatment for endometrial cancer

Primary outcomes:
measure: Endometrial Cancer Recurrence
timeFrame: 2016-2020
Secondary outcomes:
measure: Progression Free Survival
timeFrame: 2016-2020
measure: Overall Survival
timeFrame: 2016-2020
Other outcomes:
Locations:
city: York
country: United States
facility: WellSpan
state: Pennsylvania
Study officials:
affiliation: WellSpan Health-York Cancer Center
name: Eav Lim, DO
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Lee TY, Martinez-Outschoorn UE, Schilder RJ, Kim CH, Richard SD, Rosenblum NG, Johnson JM. Metformin as a Therapeutic Target in Endometrial Cancers. Front Oncol. 2018 Aug 28;8:341. doi: 10.3389/fonc.2018.00341. eCollection 2018.
citation: Xie W, Li T, Yang J, Shang M, Xiao Y, Li Q, Yang J. Metformin use and survival outcomes in endometrial cancer: a systematic review and meta-analysis. Oncotarget. 2017 Aug 22;8(42):73079-73086. doi: 10.18632/oncotarget.20388. eCollection 2017 Sep 22.