Endometrial Cancer Recurrence in Patients Taking Metformin

NCT05192850 | Withdrawn FDA Drug

• 1 other identifier: 1849612-1
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Endometrial Carcinoma

Keywords

metformin; endometrial cancer

Outcome Measures

Primary Outcomes (1)

• Endometrial Cancer Recurrence

  This is the identification of whether metformin use is associated with endometrial cancer recurrence.

  2016-2020

Secondary Outcomes (2)

• Progression Free Survival

  2016-2020

• Overall Survival

  2016-2020

Study Arms (2)

Metformin use

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

Drug: Metformin use

No metformin use

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

Interventions

Metformin use DRUG

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

Metformin use

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Participants who underwent palliative treatment for endometrial cancer

Sponsors & Collaborators

• WellSpan Health: lead

Study Sites (1)

WellSpan

York, Pennsylvania, 17403, United States

Location

Related Publications (7)

• 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.

  PMID: 23640372 BACKGROUND

• 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.

  PMID: 28409158 BACKGROUND

• 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.

  PMID: 25913129 BACKGROUND

• 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.

  PMID: 28760367 BACKGROUND

• 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.

  PMID: 24460896 BACKGROUND

• 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.

  PMID: 30211120 BACKGROUND

• 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.

  PMID: 29069850 BACKGROUND

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Eav Lim, DO

  WellSpan Health-York Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 14, 2022
• Study Start: December 27, 2021
• Primary Completion: February 27, 2023
• Study Completion: February 27, 2023
• Last Updated: March 28, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)