Clinical validation of a ctDNA-Based Assay for Multi-Cancer Detection: An Interim Report from a Vietnamese Longitudinal Prospective Cohort Study of 2795 Participants.
Thi Hue Hanh NguyenY-Thanh LuVan Hoi LeVinh Quang BuiLan Hieu NguyenNhu Hiep PhamThanh Hai PhanHuu Thinh NguyenVan Song TranChi Viet BuiVan Kha VoPham Thanh Nhan NguyenHa Huu Phuoc DangVan Dung PhamVan Thinh CaoThanh Dat NguyenLuu Hong Dang NguyenNgoc Minh PhanTrong Hieu NguyenVan Thien Chi NguyenThi Mong Quynh PhamVu Uyen TranMinh Phong LeDac Ho VoThi Minh Thu TranMinh Nguyen NguyenThi Thanh NguyenBa Linh TieuHuu Tam Phuc NguyenDinh Yen An TruongChi Thuy Tien CaoVan Tung NguyenThi Le Quyen LeThi Lan Anh LuongThi Kim Phuong DoanThi Trang DaoCanh Duy PhanThanh Xuan NguyenNguyen Tuong PhamBao Toan NguyenThi Thu Thuy PhamHuu Linh LeCong Thanh TruongThanh Xuan JasmineMinh Chi LeVan Bau PhanQuang Binh TruongThi Huong Ly TranMinh Thien HuynhTu Quy TranSi Tuan NguyenVu TranVan Khanh TranHuu Nguyen NguyenDuy Sinh NguyenThi Quynh Tho NguyenThi Van PhanThi Thanh-Thuy DoDinh-Kiet TruongHung Sang TangMinh Duy PhanHoa GiangHoai Nghia NguyenRichard L FerreroPublished in: Cancer investigation (2023)
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.
Keyphrases
- circulating tumor
- papillary thyroid
- clinical trial
- cell free
- circulating tumor cells
- squamous cell
- high throughput
- loop mediated isothermal amplification
- real time pcr
- label free
- gene expression
- lymph node metastasis
- randomized controlled trial
- squamous cell carcinoma
- study protocol
- cross sectional
- open label
- combination therapy