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

NCT06417736 · tracked via the Priya Life Science China tracker

Sponsor

Women's Hospital School Of Medicine Zhejiang University

Phase

Not applicable

Started

2023-12-01

Last updated

2024-05-16

Condition(s) studied

Endometrial Cancer Stage IEndometrial Hyperplasia

Investigational drug(s) / intervention(s)

Megestrol Acetate 40 MG

Megestrol Acetate 40 MG: 160mg/one time/day

Study 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

FEMALE

Min age

18 Years

Max age

45 Years

Healthy volunteers

Inclusion Criteria: * 1.18-45 years old with a strong desire to preserve fertility; 2. pathologically diagnosed with primary grade1 or grade2 endometrioid endometrial carcinoma and hyperplasia 3.no signs of suspicious myometrial invasion by enhanced magnetic resonance imaging (MRI) 4. no signs of suspicious extrauterine metastasis by enhanced computed tomography and CT scan of the Lungs Exclusion Criteria: * 1.have contraindication for pregnancy. 2.no fertility requiremen 3.have myometrial invasion or extrauterine metastasis 4.pathologically diagnosed with primary grade3 endometrioid endometrial carcinoma or non-endometrioid endometrial carcinoma 5.Any disease or symptom that may affect the implementation of the study or the interpretation of the results

Primary outcome measure(s)

24-week complete response(CR) rate — baseline,12 weeks after treatment,and 24 weeks of treatment
The treatment response:complete response,no endometrial lesion

Trial sites (1)

Facility	City	Region	Status
Women's Hospital School of Medicine Zhejiang University	Hangzhou	Zhejiang	Recruiting

More Women's Hospital School Of Medicine Zhejiang University trials in China

Clinical Value of ETCOc in the Diagnosis and Treatment of ABO-HDN Recruiting

Secondary Cytoreduction Followed by Chemotherapy Versus Chemotherapy Alone in Relapsed Ovarian Cancer After PARPi Maintenance Treatment: a Multicentre, Open-label, Randomised, Phase 3 Trial Recruiting

Preventive Effect of Probiotics in GDM Recruiting

Clinical Efficacy Study of PD-1 Inhibitor Combined With Neoadjuvant Chemotherapy in Advanced Endometrial Cancer Recruiting

Utility of Whole Genome Sequencing in Fetuses With Abnormal Ultrasound Findings Recruiting

Other trials for the same condition

Cohort Study of Intrauterine Diseases Recruiting

PROfiling Based Endometrial Cancer Adjuvant Therapy Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06417736 on ClinicalTrials.gov ↗ ← All trials in China