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NCT05310318 Clinical Trial

Prognosis of Low-grade Endometrial Stromal Sarcoma

Recurrence Clinical Trial

Official title:
Surgical and Reproductive Results of Fertility-sparing Treatment for Low-grade Endometrial Stromal Sarcoma: A Retrospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05310318
Other study ID # SOUM-2
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 26, 2022
Est. completion date March 26, 2025

Study information
Verified date March 2022
Source Peking Union Medical College Hospital
Contact Lei Li, M.D.
Phone 86-139-1198-8831
Email lileigh@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is to investigate the survival outcomes and fertility outcomes in patients with uterine low-grade endometrial stromal sarcoma (LGESS) treated in Peking Union Medical College Hospital. All primary and recurrent LGESS patients will be enrolled. The study will collect retrospectively data consisting of epidemiological characteristics, surgical, medical treatment and adjuvant therapy. Details about recurrence, mortality, pregnancy and obstetrical outcomes are also followed as primary endpoints. Fertility-sparing procedures, including uterine-sparing and ovary-sparing surgeries will be recorded specifically.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date March 26, 2025
Est. primary completion date March 26, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Aged 18 years or older - Confirmed of LGESS - Acceptance of surgical treatment for LGESS - With detailed follow-up outcomes Exclusion Criteria: - Not meeting all of the inclusion criteria

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Surgical treatment with and without fertility-sparing procedures
Patients accepted surgeries for LGESS and relevant adjuvant therapy if indicated.

Locations
Country Name City State
China Lei Li Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression-free survival Progression-free survival after surgery One year
Primary Overall survival Overall survival after surgery One year
Primary Pregnancy rate Pregnancy rate after surgery in patients with fertility-sparing patients One year
Secondary Miscarriage rate Miscarriage rate after surgery in patients with fertility-sparing patients One year
Secondary Full-term pregnancy rate Full-term pregnancy rate after surgery in patients with fertility-sparing patients One year
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