- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03804463
The Multicentic Trial in Fertility-sparing Treatment and Ovarian Preservation Management for Early Endometrial Cancer
January 14, 2019 updated by: Min Wang
The Randomized Multicentic Prospective Controlled Trial in Fertility-sparing Treatment and Ovarian Preservation Management for Early Endometrial Cancer
Through multicenter, prospective, randomized, controlled clinical studies comparing different treatment options (fertility-sparing surgery and ovarian preservation surgery and radical surgery)therapeutic efficacy, safety and quality of life of patients, exploration of the best strategies and risks for the treatment of early endometrial cancer, and promotion and application.
Study Overview
Status
Unknown
Conditions
Detailed Description
Patients eligible for enrollment are selected and divided into three groups randomly, including fertility group,ovarian preservation group and endometrial cancer radical surgery group.
Take interventions including fertility preservation surgery,ovarian preservation surgery and endometrial cancer radical surgery for patients in different groups respectively.
Compare therapeutic efficacy, safety and quality of life of patients to evaluate three treatment and explore the best treatment for clinical application.
Study Type
Interventional
Enrollment (Anticipated)
170
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
- Name: Min Wang, PHD.
- Phone Number: 18940251222
- Email: wm21st@126.com
Study Contact Backup
- Name: YiSi Liu
- Phone Number: 18640138683
- Email: liuyisi91@163.com
Study Locations
-
-
Liaoning
-
Shenyang, Liaoning, China, 110004
- Shengjing Hospitaol of China Medical University
-
Contact:
- Min Wang, PHD
- Phone Number: 18940251222
- Email: wm21st@126.com
-
-
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
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Premenopausal women, age ≤ 50 years
- Surgical curettage / hysteroscopic pathology confirmed, endometrioid adenocarcinoma G1/G2 (including well-differentiated, high-medium and middle-differentiation);
- Clinical consideration of IA (<1/2 muscle infiltration);
- First-time treatment
- The subject (or his legal representative) must understand the nature of the study and sign an informed consent form.
Exclusion Criteria:
- At the same time participate in other clinical trials;
- Can not tolerate surgery;
- Ovarian suspicious metastasis;
- Have a family history of ovarian cancer;
- Incorporate other malignant tumors;
- Preoperative CA125 abnormal persons
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: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: radical surgery group
Endometrial cancer radical surgery to be administered in this arm.
|
Take hysterectomy and bilateral adnexectomy.
|
Experimental: fertility preservation group
Fertility-sparing surgery to be administered in this arm.
|
Take endometrectomy , preserve uterus and bilateral ovaries.
|
Experimental: ovarian preservation group
Ovarian preservation surgery to be administered in this arm.
|
Take hysterectomy,preserve bilateral ovaries.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total survival Time
Time Frame: 6 months
|
calculate the time from patients enter the group to death
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the change of Ovarian volume
Time Frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
measure the ovarian volume dynamically by ultrasonography
|
6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
the change of endocrine function evaluation
Time Frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
measure the endocrine function(hormone level) dynamically by blood detection
|
6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
Progression Free Survival
Time Frame: 6 months
|
calculate the time from patients enter the group to tumor progression
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Min Wang, PHD., Shengjing Hospital
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 (Anticipated)
January 10, 2019
Primary Completion (Anticipated)
December 31, 2020
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
June 4, 2018
First Submitted That Met QC Criteria
January 14, 2019
First Posted (Actual)
January 15, 2019
Study Record Updates
Last Update Posted (Actual)
January 15, 2019
Last Update Submitted That Met QC Criteria
January 14, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017PS017K
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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