Gynecologic Malignancies Early-stage Detection by Liquid Biopsy in Peripheral Blood: a Prospective, Observational Study

Fudan University1 site in 1 country495 target enrollmentFebruary 11, 2021

ConditionsGynecologic Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gynecologic Cancer
Sponsor: Fudan University
Enrollment: 495
Locations: 1
Primary Endpoint: Sensitivity,specificity and tissue of origin accuracy of the multi-omics model as early detection for gynecologic cancers.
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a prospective study aimed to develop and 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 495 female participants, including participants with gynecologic cancers or benign diseases.

Registry

clinicaltrials.gov

Start Date

February 11, 2021

End Date

December 31, 2022

Last Updated

3 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Fudan University

Responsible Party

Principal Investigator

Xiaohua Wu MD

Director

Fudan University

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Sensitivity,specificity and tissue of origin accuracy of the multi-omics model as early detection for gynecologic cancers.

Time Frame: 12 months

Secondary Outcomes

Sensitivity and specificity of the multi-omics model in early detection of different gynecologic cancer diseases(12 months)
Sensitivity and specificity of the multi-omics model in early detection of gynecologic cancers in different stages.(12 months)