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Trial Title:
Molecular Mechanism Study of Uterine Sarcoma
NCT ID:
NCT05881967
Condition:
Uterine Sarcoma
Conditions: Official terms:
Sarcoma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Diagnostic biomarker
Description:
Diagnostic gene for uterine sarcoma
Arm group label:
Uterine fibroid
Arm group label:
Uterine sarcoma
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.
Criteria for eligibility:
Study pop:
400 patients who met the requirements includ 200 uterine sarcomas, 200 uterine
leiomyomas.
Sampling method:
Probability Sample
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Yan Li
Address:
City:
Wuhan
Zip:
430030
Country:
China
Status:
Recruiting
Contact:
Last name:
Yan Li, Dr
Phone:
13971026069
Email:
liyan@tjh.tjmu.edu.cn
Start date:
March 1, 2023
Completion date:
November 30, 2025
Lead sponsor:
Agency:
Shixuan Wang
Agency class:
Other
Source:
Tongji Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05881967
