PERformance of Multi-Cancer Early-detectIon Based on Various Biomarkers in fEmale Cancers, PERCEIVE-I

• Conditions: Gynecologic Cancer

• Registration Number: NCT04903665
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-11
• Study First Submitted: 2021-05-24
• Study First Submitted QC: 2021-05-24
• Study First Posted: 2021-05-26
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-26
• Last Update Posted: 2022-07-28
• Primary Completion: 2022-08-22
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 495

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity,specificity and tissue of origin accuracy of the multi-omics model as early detection for gynecologic cancers.	12 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China