PERformance of Multi-Cancer Early-detectIon Based on Various Biomarkers in fEmale Cancers, PERCEIVE-I
- Conditions
- Gynecologic Cancer
- Interventions
- Device: Multi-cancer early detection test
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 495
Inclusion Criteria
Not provided
Read More
Exclusion Criteria
Not provided
Read More
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cancer Arm Multi-cancer early detection test Participants with new diagnosis of gynecologic cancers, from whom blood samples will be collected. Benign Arm Multi-cancer early detection test Participants with new diagnosis of benign gynecologic diseases, from whom blood samples will be collected.
- 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 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
Trial Locations
- Locations (1)
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China