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临床试验/NCT05192850
NCT05192850撤回不适用

Endometrial Cancer Recurrence in Patients Taking Metformin

WellSpan Health1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年12月27日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
入组人数
100
试验地点
1
主要终点
Endometrial Cancer Recurrence

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • Participants who underwent palliative treatment for endometrial cancer

研究组 & 干预措施

Metformin use

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

干预措施: Metformin use (Drug)

结局指标

主要结局

Endometrial Cancer Recurrence

时间窗: 2016-2020

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

次要结局

  • Progression Free Survival(2016-2020)
  • Overall Survival(2016-2020)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eav Lim

Principal Investigator

WellSpan Health

研究点 (1)

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