RecruitingNot ApplicableNCT06417736

Prospective Study for Endometrial Carcinoma and Hyperplasia in Childbearing-age Women

Prospective Clinical Study of Fertility-sparing Treatment With a Membrane-inhibiting Formula Combined With Oral Progestins for Endometrial Carcinoma and Hyperplasia in Childbearing-age Women


Sponsor

Women's Hospital School Of Medicine Zhejiang University

Enrollment

75 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluate the effect and adverse side effects of membrane-inhibiting formula plus oral progestins as fertility-preserving treatment in patients with early-stage endometrial cancer and endometrial hyperplasia research questions:When taken with oral progestins, does the drug membrane-inhibiting formula shorten the time required for complete endometrial remission? What medical problems do participants have when taking drug membrane-inhibiting formula plus oral progestins? Efficacy, side effects, recurrence, pregnancy, and time to obtain pregnancy in different molecular classifications of POLE-mutated, mismatch repair-deficient(MMRd), p53 wild type(p53wt), and p53-abnormal(p53abn). Participants will: Take drug membrane-inhibiting formula plus oral progestins every day Visit the clinic once every 3 months for checkups, tests, and hysteroscopy Keep a diary of examination results and pathology


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring fertility-sparing treatment options for young women with early-stage endometrial cancer (uterine cancer) or precancerous changes to the uterine lining, who still want to become pregnant. Instead of removing the uterus (which is the standard treatment), this study uses hormonal therapies to treat the cancer while preserving the ability to have children. **You may be eligible if...** - You are 18–45 years old with a strong desire to preserve your fertility and have children - You have been diagnosed with early-stage (grade 1 or 2) uterine cancer or precancerous uterine lining changes - Imaging scans show no sign that the cancer has grown into the uterine muscle or spread elsewhere **You may NOT be eligible if...** - You have a medical reason you cannot become pregnant - You do not want to preserve fertility - Imaging shows the cancer has grown into the uterine muscle wall or spread to other organs - You have a more aggressive form of uterine cancer (grade 3 or a non-endometrioid type) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMegestrol Acetate 40 MG

160mg/one time/day


Locations(1)

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, China

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NCT06417736


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