Molecular Mechanism Study of Uterine Sarcoma

Sponsor
Shixuan Wang (Other)
Overall Status
Recruiting
CT.gov ID
NCT05881967
Collaborator
(none)
300
1
33
9.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Diagnostic biomarker

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 Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Molecular Mechanism Study of Uterine Sarcoma
Actual Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Nov 30, 2025
Anticipated Study Completion Date :
Nov 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Uterine sarcoma

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

Diagnostic Test: Diagnostic biomarker
Diagnostic gene for uterine sarcoma

Uterine fibroid

Participants were enrolled for surgery of uterine fibroids.

Diagnostic Test: Diagnostic biomarker
Diagnostic gene for uterine sarcoma

Outcome Measures

Primary Outcome Measures

  1. Susceptible gene in women with uterine sarcoma [baseline]

    Analyze genetic susceptibility among women exhibiting disease manifestations of uterine sarcoma

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yan Li Wuhan Hubei China 430030

Sponsors and Collaborators

  • Shixuan Wang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shixuan Wang, Professor, Tongji Hospital
ClinicalTrials.gov Identifier:
NCT05881967
Other Study ID Numbers:
  • IRB20221166
First Posted:
May 31, 2023
Last Update Posted:
May 31, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 31, 2023