# Prospective validation study: a non-invasive circulating tumor DNA-based assay for simultaneous early detection of multiple cancers in asymptomatic adults

Source: https://onco.cc/key-papers/paper-spot-mas-k-detek-bmc-med-2025/  
OnCo record `paper-spot-mas-k-detek-bmc-med-2025` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

In 9,024 Vietnamese adults without symptoms, the SPOT-MAS blood test was positive in about one in two hundred, and four in ten of those had cancer.

## Summary

K-DETEK (NCT05227261) enrolled 9,057 asymptomatic adults aged 40 or older at 75 hospitals and one research institute in Vietnam, followed for 12 months. Of 9,024 eligible, 43 (0.48%) tested positive; 17 were confirmed with cancer, 9 matching the predicted tissue of origin: positive predictive value 39.53% (95% CI 26.37 to 54.42), tissue-of-origin accuracy 52.94%. Of 8,981 negatives, 8,974 were cancer-free at 12 months (negative predictive value 99.92%). Sensitivity was 70.83% (50.83 to 85.09) and specificity 99.71% (99.58 to 99.80).

## Fields

- Kind: Key paper
- Last checked: 2026-10-29
- Journal: BMC Medicine
- Year: 2025
- DOI: 10.1186/s12916-025-03929-y
- Authors: Nguyen LHD, Nguyen THH, Le VH, et al.
- Findings: 43 of 9,024 positive (0.48%); 17 cancers; positive predictive value 39.5%.; Sensitivity 70.8% (24 cancers in total), specificity 99.71%.; Tissue of origin correct in 9 of 17.
- What it means: A prospective screening result in a lower-middle-income country, with a positive predictive value similar to PATHFINDER's; the sensitivity rests on 24 cancers, and the test's tissue call was right about half the time.
- Caveats: Single-arm; 24 cancers in total, so wide confidence intervals.; No stage I figure in the abstract.; Sponsored by Gene Solutions.

## Sources

- BMC Medicine 2025: K-DETEK: https://doi.org/10.1186/s12916-025-03929-y
- PubMed: https://pubmed.ncbi.nlm.nih.gov/39948555/
- ClinicalTrials.gov NCT05227261: https://clinicaltrials.gov/study/NCT05227261

## Connected records

- fronts: [Early Detection & Screening](https://onco.cc/fronts/early-detection/)
- technologies: [cfDNA fragmentomics](https://onco.cc/technologies/fragmentomics/), [Multi-cancer early detection (MCED)](https://onco.cc/technologies/mced/)
- drugs: [SPOT-MAS](https://onco.cc/drugs/spot-mas/)
- companies: [Gene Solutions](https://onco.cc/companies/gene-solutions/)
- terms: [Positive predictive value (PPV)](https://onco.cc/terms/ppv/)
- trials: [K-DETEK (SPOT-MAS in adults without symptoms, Vietnam)](https://onco.cc/trials/k-detek/)

---
JSON: https://onco.cc/api/v1/entities/paper-spot-mas-k-detek-bmc-med-2025.json