Predicting progesterone sensitivity in early endometrial cancer patients
Department of Obstetrics & Gynecology ，Peking University People's Hospital
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 |
|---|---|
| Enrollment | 244 (estimated) |
| Ages | 17 Years to 45 Years |
| Sex | Female |
| Sponsor | Peking University People's Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05647109 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include women with early endometrial carcinoma or atypical endometrial hyperplasia who wish to preserve their reproductive function.
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.
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 performed: While similar predictive models have been explored, this specific approach using patient-derived tumor-like cell clusters is relatively novel.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: WANG JIANLIU, PhD/MD
- Email: wangjianliu1203@163.com
- Phone: 8601088324383
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.