The Unintrusive Detection of EaRly-stage Cancers
Completed
- Conditions
- Cancer
- Interventions
- Device: Multi-cancer early detection test
- Registration Number
- NCT04820868
- Lead Sponsor
- Shanghai Zhongshan Hospital
- Brief Summary
According to a previous study, a cell-free DNA (cfDNA) methylation-based model showed high sensitivity and specificity (80.6% and 98.3%) in blood-based multi-cancer detection. In this way, a multi-center, prospective, single-blind study (THUNDER study) is designed to further validate the performance of the cfDNA methylation-based model for early cancer detection. Blood RNA markers will also be evaluated. The study will enroll approximately 2508 participants, including participants with malignancies and healthy participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2508
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
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 cancer, from whom blood samples will be collected Healthy Arm Multi-cancer early detection test Participants without known presence of malignancies or benign diseases, from whom blood samples will be collected
- Primary Outcome Measures
Name Time Method Sensitivity and specificity of early detection of 6 types of cancers and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model 7 months
- Secondary Outcome Measures
Name Time Method Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model in different stages or pathological types of cancer 7 months
Trial Locations
- Locations (1)
Zhongshan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China