Prognosis of Low-grade Endometrial Stromal Sarcoma

NCT05310318 | Unknown

• 1 other identifier: SOUM-2
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Grade Endometrial Stromal Sarcoma of Uterus (Diagnosis); Fertility-sparing Surgery; Survival Outcomes; Fertility Outcomes; Recurrence; Hormone Therapy; Adjuvant Therapy

Outcome Measures

Primary Outcomes (3)

• Progression-free survival

  Progression-free survival after surgery

  One year

• Overall survival

  Overall survival after surgery

  One year

• Pregnancy rate

  Pregnancy rate after surgery in patients with fertility-sparing patients

  One year

Secondary Outcomes (2)

• Miscarriage rate

  One year

• Full-term pregnancy rate

  One year

Interventions

Surgical treatment with and without fertility-sparing procedures PROCEDURE

Patients accepted surgeries for LGESS and relevant adjuvant therapy if indicated.

Also known as: Adjuvant therapy after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients accepted surgical treatment with and without fertility-sparing procedures for uterine low-grade endometrial stromal sarcoma.

You may qualify if:

• Aged 18 years or older
• Confirmed of LGESS
• Acceptance of surgical treatment for LGESS
• With detailed follow-up outcomes

Sponsors & Collaborators

• Lei Li: lead

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Endometrial Stromal Tumors; Disease; Recurrence

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Endometrial Neoplasms; Uterine Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Lei Li, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, M.D.

CONTACT

86-139-1198-8831; lileigh@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 26, 2022
• First Posted: April 4, 2022
• Study Start: March 26, 2022
• Primary Completion: March 26, 2024
• Study Completion: March 26, 2025
• Last Updated: April 4, 2022

Record last verified: 2022-03

Locations

CN (1)