Clinical validation of a ctDNA-Based Assay for Multi-Cancer Detection: An Interim Report from a Vietnamese Longitudinal Prospective Cohort Study of 2795 Participants
Thị Huệ Hạnh Nguyễn, Y‐Thanh Lu, Van Hoi Le, Vinh Bui, Lan Hieu Nguyen, Như Hiệp Phạm, Thanh Hai Phan, Huu Thinh Nguyen, Huu Thinh Nguyen, Van Song Tran, Chi Viet Bui, Van Kha Vo, Pham Thanh Nhan Nguyen, Ha Huu Phuoc Dang, Văn Dũng Phạm, Van Thinh Cao, Thanh Dat Nguyen, Lưu Hồng Đăng Nguyễn, Ngoc Minh Phan, Trong Hieu Nguyen, Van Thien Chi Nguyen, Thi Mong Quynh Pham, Vu Uyen Tran, Minh Phong Lê, Dac Ho Vo, Thi Minh Thu Tran, Minh Nguyen Nguyen, Thị Thanh Bình Nguyễn, Bá Linh Tiêu, Huu Tam Phuc Nguyen, Huu Tam Phuc Nguyen, Dinh Yen An Truong, Chi Thuy Tien Cao, Van Tung Nguyen, Thi Le Quyen Le, Thi Lan Anh Luong, Thi Kim Phuong Doan, Thị Trang Đào, Canh Duy Phan, Thanh Xuân Nguyễn, Nguyen Tuong Pham, Bao Toan Nguyen, Thi Thu Thuy Pham, Huu Linh Le, Cong Thanh Truong, Thanh Xuan Jasmine, Minh Chi Le, Van Bau Phan, Quang Binh Truong, Thi Huong Ly Tran, Minh Thien Huynh, Tu Quy Tran, Si Tuan Nguyen, Vu Tran, Văn Khanh Trần, Huu Nguyen Nguyen, Huu Nguyen Nguyen, Duy Sinh Nguyen, Thi Quynh Tho Nguyen, Thi Van Phan, Thi Thanh-Thuy, Dinh‐Kiet Truong, Hung Sang Tang, Minh‐Duy Phan, Hoa Giang, Hoai Nghia Nguyen, Hoai Nghia Nguyen, Le Son Tran
Abstract
The SPOT-MAS assay "Screening for the Presence Of Tumor by Methylation And Size" detects the five most common cancers in Vietnam by evaluating circulating tumor DNA in the blood. Here, we validated its performance in a prospective multi-center clinical trial, K-DETEK. Our analysis of 2795 participants from 14 sites across Vietnam demonstrates its ability to detect cancers in asymptomatic individuals with a positive predictive value of 60%, with 83.3% accuracy in detecting tumor location. We present a case report to support further using SPOT-MAS as a complementary method to achieve early cancer detection and provide the opportunity for early treatment.