PRediction Of Five Usual Tumors Using Blood Test for Risk Assessment and Early Detection
- Conditions
- CancerNeoplasms
- Interventions
- Device: Multi-cancer early detection test
- Registration Number
- NCT05874648
- Lead Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Brief Summary
Liquid biopsy technology based on cell-free nucleic acids and protein characteristics has unique advantages and significant application prospects in cancer early detection. The purpose of this study is to collect peripheral blood samples from participants with new diagnosis of cancer and from participants who do not have a diagnosis of cancer in order to develop machine learning models for discovering cancer from non-cancer.
- Detailed Description
The PROFUTURE study: A prospective, multicenter, observational, case-control study with collection of peripheral blood and clinical data from clinical networks in order to develop machine learning models for discovering cancer from non-cancer. According to the statistical hypothesis based on expected detection performance, the study will enroll approximately 3,830 participants, including 2,138 participants with cancer (case arm) and approximately 1,692 representative participants without a clinical diagnosis of cancer after medical screening (control arm). Participants pre-matched by age and gender will be divided into training set and validation set in a ratio of approximately 7:3. The validation set will be blinded until the models are developed. Clinical information, demographics, and medical data relevant to cancer status are collected from all participants and their medical records at baseline. The participants of control arm will be asked to report suspected cancer diagnosis status within 6 months after blood collection.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 3830
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Non-cancer arm Multi-cancer early detection test - Cancer arm Multi-cancer early detection test -
- Primary Outcome Measures
Name Time Method Sensitivity of predefined five types of cancers and specificity of non-cancers and in different subgroup of cfDNA methylation-based model at 95% confidence interval. 12 months Tissue of origin (TOO) accuracy of five types of cancers of cfDNA methylation-based model at 95% confidence interval. 12 months
- Secondary Outcome Measures
Name Time Method Sensitivity, specificity and TOO accuracy of five types of cancers of a multi-omics model at 95% confidence interval. 12 months Sensitivity, specificity and TOO accuracy of cfDNA methylation-based model and multi-omics model in different stages or pathological types of five types of cancers at 95% confidence intervals. 12 months
Trial Locations
- Locations (1)
The Sixth Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China