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

May 12, 2024 updated by: Women's Hospital School Of Medicine Zhejiang University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 321006
        • Recruiting
        • Women's Hospital School Of Medicine Zhejiang University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: membrane-inhibiting formula combined with oral progestins
Megestrol acetate(160mg/day) and membrane-inhibiting formula, 24weeks
Drug: Megestrol Acetate 40 MG
160mg/one time/day
Other Names:
  • membrane-inhibiting formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-week complete response(CR) rate
Time Frame: baseline,12 weeks after treatment,and 24 weeks of treatment
The treatment response:complete response,no endometrial lesion
baseline,12 weeks after treatment,and 24 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
36-week CR rate
Time Frame: baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment
The treatment response:complete response,no endometrial lesion
baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment
48-week CR rate
Time Frame: baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment
The treatment response:complete response,no endometrial lesion
baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment
treatment-related adverse events
Time Frame: baseline,12 weeks after treatment,and 24 weeks of treatment
analyze the safety of the drug
baseline,12 weeks after treatment,and 24 weeks of treatment
recurrent rate
Time Frame: baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment
cumulative recurrent rate
baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment
pregnancy rate
Time Frame: 1-year after CR
long term fertility results
1-year after CR

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
CR in different molecular classification
Time Frame: baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment
Efficacy in different molecular classification of POLE-mutated, mismatch repair-deficient(MMRd), p53 wild type(p53wt),and p53-abnormal(p53abn)
baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women's Hospital School Of Medicine Zhejiang University

Investigators

  • Principal Investigator: Yang Li, Doctor, Women's Hospital School Of Medicine Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 12, 2024

First Submitted That Met QC Criteria

May 12, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 12, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO2023-3614

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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