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Performance of Multi-Cancer Detection Test in Asymptomatic Patients With Neoplastic Lesions
Sponsor: Sun Yat-sen University
Summary
This multicenter, observational case-only study will evaluate the clinical performance of a blood-based, cell-free DNA (cfDNA) methylation multi-cancer early detection (MCED) test in adults aged 50 to 74 years with confirmed invasive cancer or selected high-risk precancerous lesions/carcinoma in situ. The study will primarily recruit patients who had no cancer-related symptoms before diagnosis. An additional tissue-of-origin (TOO) model optimization cohort will include patients with urothelial cancer, colorectal advanced adenoma, gastric high-grade dysplasia, or esophageal high-grade dysplasia, irrespective of symptom status.
Official title: Performance Validation of a Blood-Based Multi-Cancer Early Detection Model in Asymptomatic Patients With Cancer and Precancerous Lesions: A Multicenter Case-Only Study
Key Details
Gender
All
Age Range
50 Years - 74 Years
Study Type
OBSERVATIONAL
Enrollment
948
Start Date
2026-11-01
Completion Date
2027-12-31
Last Updated
2026-11-04
Healthy Volunteers
No
Interventions
MCED
A cfDNA methylation-based multi-cancer early detection (MCED) test designed to screen for 16 cancer types in a single assay.