Molecular Mechanism Study of Uterine Sarcoma

Uterine Sarcoma Clinical Trial

Official title:

Molecular Mechanism Study of Uterine Sarcoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05881967
• Other study ID #: IRB20221166
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: May 2023
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sarcoma
• Uterine Sarcoma

Intervention

Diagnostic Test:
• Diagnostic biomarker
Diagnostic gene for uterine sarcoma

Locations

Country	Name	City	State
China	Yan Li	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Shixuan Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Susceptible gene in women with uterine sarcoma	Analyze genetic susceptibility among women exhibiting disease manifestations of uterine sarcoma	baseline