Predicting progesterone sensitivity in early endometrial cancer patients
Official title: Department of Obstetrics & Gynecology ,Peking University People's Hospital
Run by Peking University People's Hospital · NCT05647109 · Data updated 2026-11-12
This study is testing a new way to predict how well early endometrial cancer patients will respond to progesterone treatments using their own tumor cells.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 17 Years to 45 Years |
| Sex | Women only |
| Enrollment | 244 (estimated) |
| Sponsor | Peking University People's Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | September 1, 2021 |
| Main results expected | August 31, 2025 |
| Study ends | October 31, 2025 |
| Registry record updated | May 4, 2025 |
| Trial ID | NCT05647109 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include women with early endometrial carcinoma or atypical endometrial hyperplasia who wish to preserve their reproductive function.
✕Probably not a fit
Patients with acute liver disease, renal dysfunction, or those who are pregnant or have a confirmed diagnosis of any reproductive system cancer may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to develop a prediction model for progesterone sensitivity in patients diagnosed with early endometrial carcinoma or atypical endometrial hyperplasia. After diagnosis via hysteroscopy, eligible patients will receive daily doses of Medroxyprogesterone acetate or Megestrol acetate, with regular evaluations through hysteroscopy every three months. The study will analyze patient-derived tumor-like cell clusters to assess lipid content and construct a predictive model based on the collected data from 148 cases. The model will then be validated to determine its effectiveness in predicting treatment responses.
Why it matters
Potential benefit: If successful, this study could help tailor progesterone treatments for patients with early endometrial cancer, potentially improving fertility preservation outcomes.
How similar studies have gone: While similar predictive models have been explored, this specific approach using patient-derived tumor-like cell clusters is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have a confirmed pathological diagnosis based upon hysteroscopy: atypical endometrial hyperplasia or histologically prove well-differentiated EEC G1 without myometrial invasion * No signs of suspicious extrauterine involvement on enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT) or ultrasound * Have a desire for remaining reproductive function or uterus * Good compliance with adjunctive treatment and follow-up Exclusion Criteria: * Acute liver disease or liver tumor (benign or malignant) or renal dysfunction * Pregnancy or potential pregnancy * Confirmed diagnosis of any cancer in reproductive system * Acute severe disease such as stroke or heart infarction or a history of thrombosis disease * Hypersensitivity or contradiction for using MPA or MA * With other factors of reproductive dysfunction; * Strong request for uterine removal or other conservative treatment
Where it's running
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Peking University People's Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: WANG JIANLIU, PhD/MD
- Email: wangjianliu1203@163.com
- Phone: 8601088324383
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Liquid biopsy screening for early endometrial cancer in regional China
A non-invasive blood test using cell-free DNA is being tested to see if it can detect early endometrial cancer and tell apart benign from malignant uterine lesions.
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Intrauterine type III collagen injection plus progestin for fertility-preserving endometrial cancer or atypical hyperplasia
This test sees if adding an intrauterine injection of recombinant humanized type III collagen to high‑dose progestin helps women with early endometrial cancer or atypical hyperplasia preserve fertility and achieve tumor remission.
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Using GnRHa and Letrozole for Obese Women with Progestin-Insensitive Endometrial Cancer
This study is testing a new treatment combining GnRH antagonist and letrozole to see if it helps obese women with a specific type of endometrial cancer that hasn't responded to standard therapy.
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Combining GnRHa and Letrozole for Non-obese Patients with Endometrial Cancer
This study is testing if a combination of GnRHa and letrozole can help non-obese patients with early-stage endometrial cancer keep their fertility when standard treatments haven't worked.
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Weight management combined with hormonal treatment for women with endometrial atypical hyperplasia
This study is testing if combining weight management with hormonal treatments can help obese women with endometrial atypical hyperplasia who want to keep their fertility have better treatment results and pregnancy chances.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.