NCT03804463

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

January 10, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

2 years

First QC Date

June 4, 2018

Last Update Submit

January 14, 2019

Conditions

Endometrial Cancer

Keywords

Preservation of fertility surgerovarian preservationendometrial cancer

Outcome Measures

Primary Outcomes (1)

  • Total survival Time

    calculate the time from patients enter the group to death

    6 months

Secondary Outcomes (3)

  • the change of Ovarian volume

    6 months, 1 year, 2 years, 3 years, 4 years, 5 years

  • the change of endocrine function evaluation

    6 months, 1 year, 2 years, 3 years, 4 years, 5 years

  • Progression Free Survival

    6 months

Study Arms (3)

radical surgery group

EXPERIMENTAL

Endometrial cancer radical surgery to be administered in this arm.

Procedure: endometrial cancer radical surgery

fertility preservation group

EXPERIMENTAL

Fertility-sparing surgery to be administered in this arm.

Procedure: fertility-sparing surgery

ovarian preservation group

EXPERIMENTAL

Ovarian preservation surgery to be administered in this arm.

Procedure: ovarian preservation surgery

Interventions

endometrial cancer radical surgeryPROCEDURE

Take hysterectomy and bilateral adnexectomy.

radical surgery group
fertility-sparing surgeryPROCEDURE

Take endometrectomy , preserve uterus and bilateral ovaries.

fertility preservation group
ovarian preservation surgeryPROCEDURE

Take hysterectomy,preserve bilateral ovaries.

ovarian preservation group

Eligibility Criteria

Age21 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shengjing Hospitaol of China Medical University

Shenyang, Liaoning, 110004, China

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Min Wang, PHD.

    Shengjing Hospital

    STUDY DIRECTOR

Central Study Contacts

Min Wang, PHD.

CONTACT

18940251222wm21st@126.com

YiSi Liu

CONTACT

18640138683liuyisi91@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

June 4, 2018

First Posted

January 15, 2019

Study Start

January 10, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

January 15, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)