PROFOUND Study: Development and Validation of a Multi-cancer Early Detection Model Based on Peripheral Blood Multi-omic Analysis and Machine Learning: a Multicenter, Prospective, Observational, Case-control Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Shanghai Weihe Medical Laboratory Co., Ltd.
- Enrollment
- 16666
- Locations
- 2
- Primary Endpoint
- The performance of cfDNA methylation-based multiple cancers early detection model in case-control study
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This study is a multi-center, case-control study aiming at developing and blinded testing machine learning-based multiple cancers early detection model by prospectively collecting blood samples from newly diagnosed cancer patients and individuals without confirmed cancer diagnosis.
Detailed Description
Blood samples from newly diagnosed cancer patients and individuals without confirmed cancer diagnosis will be prospectively collected to identify cancer-specific circulating signals through integrative multi-omic analysis. Based on the comprehensive molecular profiling, a machine learning-driven model will be trained and blinded validated independent through a two-stage approach in clinically annotated individuals. Approximately 10327 cancer patients will be enrolled in this study and early-stage cancer patients will be enriched to improve the model sensitivity on distinguishing cancers with favorable prognosis. Approximately 6339 age and sex matched controls will be included in model development, which are volunteers without a cancer diagnosis after routine cancer screening tests.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The performance of cfDNA methylation-based multiple cancers early detection model in case-control study
Time Frame: 12 months
The sensitivity, specificity and tissue origin accuracy of cfDNA methylation-based multiple cancers early detection model in detecting cancer or non-cancer at 95% confidence interval.
Secondary Outcomes
- The performance of cfDNA methylation-based multiple cancers early detection model in early stage cancer cases(12 months)
- The performance of multi-omic-based multiple cancers early detection model in case-control study(12 months)
- The performance of different multi-cancer early detection models in different subgroups(12 months)