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

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.

Keywords:

• Liquid biopsy
• ctDNA
• clinical validation
• prospective trial
• cancer screening

Acknowledgments

We thank our K-DETEK participants for their courage and generosity. We thank Angela Marie Jansen, PhD, MHS of Angela Jansen and Associates, for her help in editing this manuscript.

Author contributions

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

Disclosure statement

The authors including LST, HNN, HG, MDP, HHN and DSN hold equity in Gene Solutions. The funder Gene Solutions provided support in the form of salaries for authors THHN, YTL, TDN, LHDN, NMP, THN, TCVN, TMQP, VUT, MPL, DHV, TMTT, MNN, TTN, BLT, HTPN, DYAT, CTTC, HNN, DSN, TQTN, TVP, TTTD, DKT, HST, MDP, HG, HNN and LST. NHN, HG, MDP and LST are inventors on the patent application (USPTO 17930705). We also confirm that this does not alter our adherence to Cancer Investigation policies on sharing data and materials.

Data availability statement

Sequencing data will be deposited in a public portal database (NCBI SRA) upon acceptance and are available on request from the corresponding author, LST. The data are not publicly available due to ethical restrictions.

Additional information

Funding

The study was funded by Gene Solutions.