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A Multi-Center Study to Develop a Multi-Cancer Early Detection Test Using Whole Genome Sequencing of Circulating DNA in Cancer Patients and Healthy Volunteers
Led by Yonsei University · Updated on 2024-01-30
4000
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating a Multi-Cancer Early Detection MCED platform using whole genome sequencing of circulating tumor DNA combined with machine learning. This prospective, multi-center observational study aims to validate this MCED platform for the early detection of invasive cancers. The study plans to enroll 4,000 subjects including cancer patients and healthy volunteers across up to 10 clinical institutions in South Korea. Participants include those diagnosed with invasive solid tumors at various stages before treatment and healthy volunteers scheduled for cancer screening tests. Blood samples and clinical information will be collected from all participants. The study does not involve experimental treatments but focuses on analyzing circulating DNA to detect cancer early. During the study, participants will provide blood samples and clinical data for analysis. Researchers will assess the diagnostic accuracy of the MCED platform by measuring the positive and negative predictive values for invasive cancer diagnosis and the concordance rate for predicting the cancer origin over a 36-month period. Participants will be monitored for up to three years to evaluate these outcomes.
CONDITIONS
Brief Title
A Prospective, Multi-center Clinical Study to Establish Multi-Cancer Early Detection Platform Through the Analysis of Whole Genome Sequencing of Circulating DNA in Cancer Patients and Healthy Volunteers
Research Team
J
Joohyuk Sohn
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