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NOT YET RECRUITING
NCT07915271

Performance of Multi-Cancer Detection Test in Asymptomatic Patients With Neoplastic Lesions

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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

OTHER

MCED

A cfDNA methylation-based multi-cancer early detection (MCED) test designed to screen for 16 cancer types in a single assay.