Endometrial Cancer Recurrence in Patients Taking Metformin

NCT ID: NCT05192850

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-27

Study Completion Date

2023-02-27

Brief Summary

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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

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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.

Conditions

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Recurrent Endometrial Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Metformin use

These participants were on metformin for any duration at any point in time in the study period

Metformin use

Intervention Type DRUG

As an observational study, this is past exposure to metformin that occurred during the study period

No metformin use

These participants were never on metformin for any duration at any point in time in the study period

No interventions assigned to this group

Interventions

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Metformin use

As an observational study, this is past exposure to metformin that occurred during the study period

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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WellSpan Health

OTHER

Sponsor Role lead

Responsible Party

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Eav Lim

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eav Lim, DO

Role: PRINCIPAL_INVESTIGATOR

WellSpan Health-York Cancer Center

Locations

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WellSpan

York, Pennsylvania, United States

Site Status

Countries

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United States

References

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Esposito K, Chiodini P, Capuano A, Bellastella G, Maiorino MI, Giugliano D. Metabolic syndrome and endometrial cancer: a meta-analysis. Endocrine. 2014 Feb;45(1):28-36. doi: 10.1007/s12020-013-9973-3. Epub 2013 May 3.

Reference Type BACKGROUND
PMID: 23640372 (View on PubMed)

Tang YL, Zhu LY, Li Y, Yu J, Wang J, Zeng XX, Hu KX, Liu JY, Xu JX. Metformin Use Is Associated with Reduced Incidence and Improved Survival of Endometrial Cancer: A Meta-Analysis. Biomed Res Int. 2017;2017:5905384. doi: 10.1155/2017/5905384. Epub 2017 Mar 20.

Reference Type BACKGROUND
PMID: 28409158 (View on PubMed)

Tseng CH. Metformin and endometrial cancer risk in Chinese women with type 2 diabetes mellitus in Taiwan. Gynecol Oncol. 2015 Jul;138(1):147-53. doi: 10.1016/j.ygyno.2015.03.059. Epub 2015 Apr 22.

Reference Type BACKGROUND
PMID: 25913129 (View on PubMed)

Meireles CG, Pereira SA, Valadares LP, Rego DF, Simeoni LA, Guerra ENS, Lofrano-Porto A. Effects of metformin on endometrial cancer: Systematic review and meta-analysis. Gynecol Oncol. 2017 Oct;147(1):167-180. doi: 10.1016/j.ygyno.2017.07.120. Epub 2017 Jul 29.

Reference Type BACKGROUND
PMID: 28760367 (View on PubMed)

Zhang ZJ, Li S. The prognostic value of metformin for cancer patients with concurrent diabetes: a systematic review and meta-analysis. Diabetes Obes Metab. 2014 Aug;16(8):707-10. doi: 10.1111/dom.12267. Epub 2014 Feb 27.

Reference Type BACKGROUND
PMID: 24460896 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30211120 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29069850 (View on PubMed)

Other Identifiers

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1849612-1

Identifier Type: -

Identifier Source: org_study_id

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