Molecular Mechanism Study of Uterine Sarcoma

NCT ID: NCT05881967

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-11-30

Brief Summary

The purpose of this project was to use multi-omics technology to screen the key factors for the occurrence and development of uterine sarcoma.

Detailed Description

Uterine sarcomas are rare mesenchymal neoplasms in the female genital system, accounting for about 1% of female reproductive tract malignancies and 3%~7% of uterine malignancies. Subtypes of uterine sarcoma are leiomyosarcoma, endometrial stromal sarcoma, and adenosarcoma. Uterine leiomyosarcoma is the most common uterine sarcoma, accounting for about 1% to 2% of all uterine malignancies.

Uterine sarcomas differ in histologic appearance and clinical behavior. The incidence of uterine sarcoma is low and the prognosis is poor. Its manifestations mainly include abnormal vaginal bleeding, abdominal pain and abdominal mass, but none of these symptoms are specific.

For uterine sarcoma, there are no diagnostic serum markers and imaging features and the diagnosis of uterine sarcoma still mainly depends on postoperative pathological results. However, with the development of omics technology, immunophenotypes and molecular characterization of uterine sarcomas have increasingly been utilized to improve diagnostic classification and prognostication in uterine sarcomas. Uterine leiomyosarcoma, the most common subtype of uterine sarcoma, does not have a single defining molecular abnormality.

This project intends to use multi-omics technology to screen the key factors for the occurrence, development, and malignant transformation of uterine sarcoma, especially uterine leiomyosarcoma, and to map the interaction network of cell signaling pathways. It provides key molecular markers for the early assessment of recurrence and malignant transformation of uterine myoma after conservative treatment, and provides a molecular mechanism basis for finding solutions to prevent the progression and malignant transformation.

Conditions

Uterine Sarcoma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Uterine sarcoma

Participants were enrolled for the first treatment of uterine sarcoma or secondary operation for recurrence fo uterine sarcoma.

Diagnostic biomarker

Intervention Type: DIAGNOSTIC_TEST

Diagnostic gene for uterine sarcoma

Uterine fibroid

Participants were enrolled for surgery of uterine fibroids.

Diagnostic biomarker

Intervention Type: DIAGNOSTIC_TEST

Diagnostic gene for uterine sarcoma

Interventions

Diagnostic biomarker

Diagnostic gene for uterine sarcoma

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Age 18 or older;

2. Newly treated or recurenced uterine sarcoma.

Exclusion Criteria

1. Diagnosis of other malignancies within the past 5 years;

2. history of pelvic or vaginal radiation therapy;

3. Known high-grade lesions of the cervix and endometrium.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shixuan Wang

OTHER

Sponsor Role: lead

Responsible Party

Shixuan Wang

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Yan Li

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yan Li, Dr

Role: primary

liyan@tjh.tjmu.edu.cn

13971026069

Other Identifiers

IRB20221166

Identifier Type: -

Identifier Source: org_study_id