Recurrent Endometrial CarcinomaNCT05192850
Endometrial Cancer Recurrence in Patients Taking Metformin
An observational study of Recurrent Endometrial Carcinoma, run by WellSpan Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Endometrial Carcinoma
- What is being tested?
- Metformin use
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2021to 27 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants who underwent initial treatment for curative intent of endometrial cancer in the WellSpan system between 2016-2020
Who may be able to join
- Participants with endometrial cancer of all histologies treated in the WellSpan system from 2016-2020
Who cannot join
- Participants who underwent palliative treatment for endometrial cancer
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Recurrent Endometrial Carcinoma
- Being tested
- Metformin use
- Keywords
- metformin, endometrial cancer
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin useDrug
As an observational study, this is past exposure to metformin that occurred during the study period
| Study group | Role | What they receive |
|---|---|---|
| Metformin use | These participants were on metformin for any duration at any point in time in the study period Receives: Drug: Metformin use | |
| No metformin use | These participants were never on metformin for any duration at any point in time in the study period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial Cancer Recurrence
This is the identification of whether metformin use is associated with endometrial cancer recurrence.
Measured: 2016-2020
Secondary outcomes (2)
Progression Free Survival
This is the identification of whether metformin use is associated with improved progression free survival of endometrial cancer.
Measured: 2016-2020
Overall Survival
This is the identification of whether metformin use is associated with improved overall survival of endometrial cancer.
Measured: 2016-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start27 Dec 2021
- Primary completion27 Feb 2023
- Study completion27 Feb 2023 (estimated)
Why it stopped: study was not started at WellSpan
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Recurrent Endometrial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- WellSpan Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eav Lim, WellSpan Health
- Investigators
- Eav Lim, DO, Principal investigator, WellSpan Health-York Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192850
- Sponsor's protocol ID
- 1849612-1
- Status last verified
- Apr 2024
- First submitted
- 23 Dec 2021
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23640372Tang 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.
PubMed 28409158Tseng 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.
PubMed 25913129Meireles 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.
PubMed 28760367Zhang 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.
PubMed 24460896Lee 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.
PubMed 30211120Xie 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.
PubMed 29069850
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Cancer Recurrence in Patients Taking Metformin
- ClinicalTrials.gov ID
- NCT05192850
- Acronym / sponsor ID
- 1849612-1
- Conditions
- Recurrent Endometrial Carcinoma
- Keywords
- metformin, endometrial cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: study was not started at WellSpan
- Enrolment
- 0 participants (actual)
- Lead sponsor
- WellSpan HealthUniversity, hospital or other
- Study start
- 27 Dec 2021 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 27 Feb 2023 (estimated)
- First posted
- 14 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin use | – | Drug: Metformin useThese participants were on metformin for any duration at any point in time in the study period |
| No metformin use | – | –These participants were never on metformin for any duration at any point in time in the study period |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who underwent initial treatment for curative intent of endometrial cancer in the WellSpan system between 2016-2020
Key inclusion criteria (1 listed)
- Participants with endometrial cancer of all histologies treated in the WellSpan system from 2016-2020
Key exclusion criteria (1 listed)
- Participants who underwent palliative treatment for endometrial cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin useAs an observational study, this is past exposure to metformin that occurred during the study period | Drug | Metformin use |
Primary outcome
Endometrial Cancer Recurrence
Time frame: 2016-2020
This is the identification of whether metformin use is associated with endometrial cancer recurrence.
2 secondary outcomes
Progression Free Survival
Time frame: 2016-2020
Overall Survival
Time frame: 2016-2020
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Background: PubMed 23640372Esposito 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.
- Background: PubMed 28409158Tang 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.
- Background: PubMed 25913129Tseng 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.
- Background: PubMed 28760367Meireles 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.
- Background: PubMed 24460896Zhang 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.
- Background: PubMed 30211120Lee 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.
- Background: PubMed 29069850Xie 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eav Lim, DO principal investigator
WellSpan Health-York Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Endometrial Carcinoma, run by WellSpan Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometrial Cancer Recurrence (time frame: 2016-2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05192850, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.