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Endometrial Cancer Recurrence in Patients Taking Metformin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05192850
Recruitment Status : Active, not recruiting
First Posted : January 14, 2022
Last Update Posted : June 15, 2022
Sponsor:
Information provided by (Responsible Party):
Eav Lim, WellSpan Health

Study Description
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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.

Condition or disease Intervention/treatment
Recurrent Endometrial Carcinoma Drug: Metformin use

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Endometrial Cancer Recurrence in Patients Taking Metformin
Actual Study Start Date : December 27, 2021
Actual Primary Completion Date : February 27, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Metformin use
These participants were on metformin for any duration at any point in time in the study period
 Drug: Metformin use
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


Outcome Measures
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Primary Outcome Measures :
  1. Endometrial Cancer Recurrence [ Time Frame: 2016-2020 ]
    This is the identification of whether metformin use is associated with endometrial cancer recurrence.


Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 2016-2020 ]
    This is the identification of whether metformin use is associated with improved progression free survival of endometrial cancer.

  2. Overall Survival [ Time Frame: 2016-2020 ]
    This is the identification of whether metformin use is associated with improved overall survival of endometrial cancer.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05192850


Locations
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United States, Pennsylvania
WellSpan
York, Pennsylvania, United States, 17403
Sponsors and Collaborators
WellSpan Health
Investigators
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Principal Investigator: Eav Lim, DO WellSpan Health-York Cancer Center
More Information
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Publications:

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Responsible Party: Eav Lim, Principal Investigator, WellSpan Health
ClinicalTrials.gov Identifier: NCT05192850    
Other Study ID Numbers: 1849612-1
First Posted: January 14, 2022    Key Record Dates
Last Update Posted: June 15, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eav Lim, WellSpan Health:
metformin
endometrial cancer
Additional relevant MeSH terms:
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Endometrial Neoplasms
Recurrence
Disease Attributes
Pathologic Processes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Uterine Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs