The Multicentic Trial in Fertility-sparing Treatment and Ovarian Preservation Management for Early Endometrial Cancer

NCT ID: NCT03804463

Last Updated: 2019-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-10

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Endometrial Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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radical surgery group

Endometrial cancer radical surgery to be administered in this arm.

Group Type EXPERIMENTAL

endometrial cancer radical surgery

Intervention Type PROCEDURE

Take hysterectomy and bilateral adnexectomy.

fertility preservation group

Fertility-sparing surgery to be administered in this arm.

Group Type EXPERIMENTAL

fertility-sparing surgery

Intervention Type PROCEDURE

Take endometrectomy , preserve uterus and bilateral ovaries.

ovarian preservation group

Ovarian preservation surgery to be administered in this arm.

Group Type EXPERIMENTAL

ovarian preservation surgery

Intervention Type PROCEDURE

Take hysterectomy,preserve bilateral ovaries.

Interventions

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endometrial cancer radical surgery

Take hysterectomy and bilateral adnexectomy.

Intervention Type PROCEDURE

fertility-sparing surgery

Take endometrectomy , preserve uterus and bilateral ovaries.

Intervention Type PROCEDURE

ovarian preservation surgery

Take hysterectomy,preserve bilateral ovaries.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Premenopausal women, age ≤ 50 years
2. Surgical curettage / hysteroscopic pathology confirmed, endometrioid adenocarcinoma G1/G2 (including well-differentiated, high-medium and middle-differentiation);
3. Clinical consideration of IA (\<1/2 muscle infiltration);
4. First-time treatment
5. The subject (or his legal representative) must understand the nature of the study and sign an informed consent form.

Exclusion Criteria

1. At the same time participate in other clinical trials;
2. Can not tolerate surgery;
3. Ovarian suspicious metastasis;
4. Have a family history of ovarian cancer;
5. Incorporate other malignant tumors;
6. Preoperative CA125 abnormal persons
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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First Hospital of China Medical University

OTHER

Sponsor Role collaborator

Min Wang

OTHER

Sponsor Role lead

Responsible Party

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Min Wang

Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Min Wang, PHD.

Role: STUDY_DIRECTOR

Shengjing Hospital

Locations

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Shengjing Hospitaol of China Medical University

Shenyang, Liaoning, China

Site Status

Countries

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China

Central Contacts

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Min Wang, PHD.

Role: CONTACT

18940251222

YiSi Liu

Role: CONTACT

18640138683

Facility Contacts

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Min Wang, PHD

Role: primary

18940251222

Other Identifiers

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2017PS017K

Identifier Type: -

Identifier Source: org_study_id

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