基于循环肿瘤DNA（ctDNA）的多癌检测分析方法的临床验证：来自越南一项针对2795名参与者的纵向前瞻性队列研究的中期报告

Clinical validation of a ctDNA-Based Assay for Multi-Cancer Detection: An Interim Report from a Vietnamese Longitudinal Prospective Cohort Study of 2795 Participants.

作者信息

Nguyen Thi Hue Hanh, Lu Y-Thanh, Le Van Hoi, Bui Vinh Quang, Nguyen Lan Hieu, Pham Nhu Hiep, Phan Thanh Hai, Nguyen Huu Thinh, Tran Van Song, Bui Chi Viet, Vo Van Kha, Nguyen Pham Thanh Nhan, Dang Ha Huu Phuoc, Pham Van Dung, Cao Van Thinh, Nguyen Thanh Dat, Nguyen Luu Hong Dang, Phan Ngoc Minh, Nguyen Trong Hieu, Nguyen Van Thien Chi, Pham Thi Mong Quynh, Tran Vu Uyen, Le Minh Phong, Vo Dac Ho, Tran Thi Minh Thu, Nguyen Minh Nguyen, Nguyen Thi Thanh, Tieu Ba Linh, Nguyen Huu Tam Phuc, Truong Dinh Yen An, Cao Chi Thuy Tien, Nguyen Van Tung, Le Thi Le Quyen, Luong Thi Lan Anh, Doan Thi Kim Phuong, Dao Thi Trang, Phan Canh Duy, Nguyen Thanh Xuan, Pham Nguyen Tuong, Nguyen Bao Toan, Pham Thi Thu Thuy, Le Huu Linh, Truong Cong Thanh, Jasmine Thanh Xuan, Le Minh Chi, Phan Van Bau, Truong Quang Binh, Tran Thi Huong Ly, Huynh Minh Thien, Tran Tu Quy, Nguyen Si Tuan, Tran Vu, Tran Van Khanh, Nguyen Huu Nguyen, Nguyen Duy Sinh, Nguyen Thi Quynh Tho, Phan Thi Van, Do Thi Thanh-Thuy, Truong Dinh-Kiet, Tang Hung Sang, Phan Minh Duy, Giang Hoa, Nguyen Hoai Nghia, Tran Le Son

机构信息

Research and Development Department, Gene Solutions, Ho Chi Minh, Vietnam.

Medical Genetics Institute, Ho Chi Minh, Vietnam.

出版信息

Cancer Invest. 2023 Feb 6:1-17. doi: 10.1080/07357907.2023.2173773.

DOI:10.1080/07357907.2023.2173773

PMID:36719061

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.

摘要

SPOT-MAS检测法（“通过甲基化和大小筛查肿瘤的存在”）通过评估血液中的循环肿瘤DNA来检测越南五种最常见的癌症。在此，我们在一项前瞻性多中心临床试验K-DETEK中验证了其性能。我们对来自越南各地14个地点的2795名参与者的分析表明，它能够检测无症状个体中的癌症，阳性预测值为60%，检测肿瘤位置的准确率为83.3%。我们提供了一份病例报告，以支持进一步将SPOT-MAS用作辅助方法来实现癌症早期检测，并为早期治疗提供机会。