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Updated: Jan 13, 2026
Detection and Monitoring of Tumor Associated Circulating DNA in Patient Biofluids
Published on: June 8, 2019
Direct Comparison of Tumor-Informed and Tumor-Naive Circulating Tumor DNA Assays for Recurrence Detection in
Van-Anh Nguyen Hoang1,2, Ngoc Nguyen1,2, Tu Nguyen1,2
1Medical Genetics Institute, Ho Chi Minh City, Vietnam.
Background:
Circulating tumor DNA (ctDNA) is a promising prognostic biomarker in early-stage NSCLC. The typical tumor-informed method of ctDNA testing requires tissue specimens of high quality, which is a challenge in developing countries. Tumor-naive approach is an alternative, but the performance of the two methods has not been directly compared using the same samples and platform.
Methods:
We retrospectively analyzed tumor and blood samples of patients with early-stage NSCLC enrolled in our published study. For analytical performance, pretreatment samples of 42 patients and 50 healthy donors were used to assess the accuracy of ctDNA detection. For clinical performance, 176 postsurgical blood samples of 76 patients with NSCLC were analyzed to compare the ctDNA status with recorded clinical recurrence. The tumor-informed method evaluated personalized mutations and a fixed 500-hotspot panel, whereas the tumor-naive method combined predesigned mutation panels and nonmutation genome-wide features of ctDNA.
Results:
The tumor-informed assay had 66.7% sensitivity and 99.3% specificity for detecting ctDNA in early-stage NSCLC, higher than the tumor-naive assay with 52.6% sensitivity and 95.7% specificity. Postsurgical ctDNA status determined by both methods had significant prognostic value to predict recurrence ahead of clinical diagnosis (hazard ratio >100, p < 0.0001). Tumor-informed ctDNA achieved 86.7% sensitivity to detect recurrence, and the 500-hotspot panel improved the ctDNA detection rate for cases with suboptimal tissue specimens. Tumor-naive ctDNA had 80.0% sensitivity to detect recurrence, and integration of nonmutation features was crucial.
Conclusions:
Both methods exhibited high accuracy in detecting residual cancer in NSCLC. The tumor-naive approach is a reliable alternative when high-quality tissue specimens are unavailable.
