Molecular Mechanism Study of Uterine Sarcoma

Recruiting

• Conditions: Uterine Sarcoma
• Interventions: Diagnostic Test: Diagnostic biomarker

• Registration Number: NCT05881967
• Lead Sponsor: Shixuan Wang

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.

Study Timeline

• Study Start: 2023-03-01
• Status Verified: 2023-05
• Study First Submitted: 2023-05-21
• Study First Submitted QC: 2023-05-21
• Last Update Submitted: 2023-05-21
• Study First Posted: 2023-05-31
• Last Update Posted: 2023-05-31
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Uterine fibroid	Diagnostic biomarker	Participants were enrolled for surgery of uterine fibroids.
Uterine sarcoma	Diagnostic biomarker	Participants were enrolled for the first treatment of uterine sarcoma or secondary operation for recurrence fo uterine sarcoma.

Primary Outcome Measures

Name	Time	Method
Susceptible gene in women with uterine sarcoma	baseline	Analyze genetic susceptibility among women exhibiting disease manifestations of uterine sarcoma

Trial Locations

Locations (1)

Yan Li; 🇨🇳 Wuhan, Hubei, China