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Study of OverC Blood Test for Early Cancer Detection in Adults Aged 40 to 75 at Risk
Led by Guangzhou Burning Rock Dx Co., Ltd. · Updated on 2022-07-06
12500
Participants Needed
1
Research Sites
252 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the performance of the OverC multi-cancer detection blood test in people aged 40 to 75 who are at risk for cancer but do not show symptoms. This prospective, multicenter, interventional study aims to understand how well this blood test detects various cancers early and records details like cancer types and stages when diagnosed. The study is sponsored by Guangzhou Burning Rock Dx Co., Ltd. and will take place at up to 30 clinical sites within China. Participants will receive the OverC multi-cancer detection blood test alongside standard cancer screening tests. The results from both tests will be shared with health care providers and participants. Diagnostic procedures will first be guided by the blood test results, followed by standard screening methods. The study plans to enroll about 12,500 participants over approximately 9 months, focusing on those with specific cancer risks to increase observed cancer cases. Participants will be actively followed for about 5 years after enrollment. Researchers will collect blood samples, track cancer diagnoses, and evaluate the effectiveness of the blood test by measuring sensitivity, specificity, and predictive values at 1, 3, and 5 years. They will also assess participants quality of life, anxiety levels, and satisfaction with the test during this time. Safety and disease progression will be monitored throughout the study period.
CONDITIONS
Brief Title
Multi-canceR Early-detection Test in Asymptomatic Individuals (PREVENT)
Research Team
S
Shangli Cai
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