Gynecological Malignancies Earlystage Detection by Multi-omics Based Liquid Biopsy in Peripheral Blood: a Prospective, Extended Validation Study

Fudan University1 site in 1 country2,935 target enrollmentFebruary 22, 2023

ConditionsGynecologic Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gynecologic Cancer
Sponsor: Fudan University
Enrollment: 2935
Locations: 1
Primary Endpoint: To validate the sensitivity, specificity and accuracy of tissue traceability of an early detection model based on combined cfDNA methylation and serum tumor markers in patients with gynecological malignancies
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a prospective study aimed to validate the performance of combined multi-omitcs assays for early detection of gynecologic cancers. Biomarkers of cfDNA methylation, ctDNA mutation and blood miRNA markers will be evaluated. The study will enroll approximately 2935 female participants, including participants with gynecologic cancers patients and healthy participants.

Registry

clinicaltrials.gov

Start Date

February 22, 2023

End Date

December 31, 2024

Last Updated

2 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Fudan University

Responsible Party

Principal Investigator

Zhong Zheng MD

Department of Gynecological Oncology, Fudan University Shanghai Cancer Center

Fudan University

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

To validate the sensitivity, specificity and accuracy of tissue traceability of an early detection model based on combined cfDNA methylation and serum tumor markers in patients with gynecological malignancies

Time Frame: 24 months

Secondary Outcomes

To verify the sensitivity and specificity of serum tumor markers alone as an early detection model for gynecological malignant tumors(24months)
To verify the sensitivity, specificity and tissue traceability accuracy of cfDNA methylation as an early detection model for gynecological malignancies.(24months)