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Trial Title:
Prospective Study for Endometrial Carcinoma and Hyperplasia in Childbearing-age Women
NCT ID:
NCT06417736
Condition:
Endometrial Cancer Stage I
Endometrial Hyperplasia
Conditions: Official terms:
Endometrial Neoplasms
Endometrial Hyperplasia
Hyperplasia
Megestrol
Megestrol Acetate
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Megestrol Acetate 40 MG
Description:
160mg/one time/day
Arm group label:
membrane-inhibiting formula combined with oral progestins
Other name:
membrane-inhibiting formula
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
Criteria for eligibility:
Criteria:
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
Gender:
Female
Gender based:
Yes
Gender description:
female
Minimum age:
18 Years
Maximum age:
45 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Women's Hospital School of Medicine Zhejiang University
Address:
City:
Hangzhou
Zip:
321006
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Yang
Phone:
0086-18268165386
Email:
5516015@zju.edu.cn
Start date:
December 1, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Women's Hospital School Of Medicine Zhejiang University
Agency class:
Other
Source:
Women's Hospital School Of Medicine Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06417736
