Evidence map›Paper›PMID 39948555›Full record

Observational studyBMC medicine2025

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

Luu Hong Dang Nguyen, Thi Hue Hanh Nguyen, Van Hoi Le, Vinh Quang Bui, Lan Hieu Nguyen, Nhu Hiep Pham, Thanh Hai Phan, Huu Thinh Nguyen, Van Song Tran, Chi Viet Bui and 60 more

Registry-linked trialAbstract readMulticenter StudyObservational StudyValidation Study
In one paragraph

Observational study in BMC medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05227261 (Assessment of a Novel Blood Test in Early Detection of the Five Common Cancers Based on the Investigation of the Circulating Tumour DNA), which is not on this map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05227261 completednot on this map

Assessment of a Novel Blood Test in Early Detection of the Five Common Cancers Based on the Investigation of the Circulating Tumour DNA

TypeobservationalSponsorGene SolutionsRan2022 to 2024Enrolled9,057ConditionsCancer, Lung, Cancer, Breast, Cancer Liver, Cancer, Colorectal
3 · Its place in the literature

Who cites it

20 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Review
  6. Review
  7. Article
  8. Article
  9. Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

70 authors.

Luu Hong Dang Nguyen *Medical Genetics Institute, Ho Chi Minh, Vietnam.
Thi Hue Hanh Nguyen *Medical Genetics Institute, Ho Chi Minh, Vietnam.
Van Hoi LeNational Cancer Hospital, Hanoi, Vietnam.
Vinh Quang BuiHanoi Oncology Hospital, Hanoi, Vietnam.
Lan Hieu NguyenHanoi Medical University Hospital, Hanoi Medical University, Hanoi, Vietnam.
Nhu Hiep PhamHue Central Hospital, Hue, Vietnam.
Thanh Hai PhanMedic Medical Center, Ho Chi Minh, Vietnam.
Huu Thinh NguyenUniversity Medical Center HCM, Ho Chi Minh, Vietnam.
Van Song TranPeople's Hospital 115, Ho Chi Minh, Vietnam.
Chi Viet BuiXuyen A General Hospital, Ho Chi Minh, Vietnam.
Van Kha VoCantho Oncology Hospital, Can Tho, Vietnam.
Pham Thanh Nhan NguyenDanang Oncology Hospital, Da Nang, Vietnam.
Ha Huu Phuoc DangDongnai General Hospital, Bien Hoa, Vietnam.
Van Dung PhamThong Nhat Dongnai General Hospital, Bien Hoa, Vietnam.
Van Thinh CaoLe Van Thinh Hospital, Ho Chi Minh, Vietnam.
Ngoc Minh PhanMedical Genetics Institute, Ho Chi Minh, Vietnam.
Ba Linh TieuMedical Genetics Institute, Ho Chi Minh, Vietnam.
Giang Thi Huong NguyenMedical Genetics Institute, Ho Chi Minh, Vietnam.
Dac Ho VoMedical Genetics Institute, Ho Chi Minh, Vietnam.
Trung Hieu TranMedical Genetics Institute, Ho Chi Minh, Vietnam.
Thanh Dat NguyenMedical Genetics Institute, Ho Chi Minh, Vietnam.
Van Thien Chi NguyenMedical Genetics Institute, Ho Chi Minh, Vietnam.
Trong Hieu NguyenMedical Genetics Institute, Ho Chi Minh, Vietnam.
Vu Uyen TranMedical Genetics Institute, Ho Chi Minh, Vietnam.
Minh Phong LeMedical Genetics Institute, Ho Chi Minh, Vietnam.
Thi Minh Thu TranMedical Genetics Institute, Ho Chi Minh, Vietnam.
Minh Nguyen NguyenMedical Genetics Institute, Ho Chi Minh, Vietnam.
Thi Tuong Vi VanMedical Genetics Institute, Ho Chi Minh, Vietnam.
Anh Nhu NguyenMedical Genetics Institute, Ho Chi Minh, Vietnam.
Thi Thanh NguyenMedical Genetics Institute, Ho Chi Minh, Vietnam.
Nhu Nhat Tan DoanMedical Genetics Institute, Ho Chi Minh, Vietnam.
Hoang Tan NguyenMedical Genetics Institute, Ho Chi Minh, Vietnam.
Phuoc Loc DoanMedical Genetics Institute, Ho Chi Minh, Vietnam.
Le Anh Khoa HuynhMedical Genetics Institute, Ho Chi Minh, Vietnam.
Tien Anh NguyenMedical Genetics Institute, Ho Chi Minh, Vietnam.
Huu Tam Phuc NguyenMedical Genetics Institute, Ho Chi Minh, Vietnam.
Y-Thanh LuMedical Genetics Institute, Ho Chi Minh, Vietnam.
Chi Thuy Tien CaoMedical Genetics Institute, Ho Chi Minh, Vietnam.
Van Tung NguyenNational Cancer Hospital, Hanoi, Vietnam.
Thi Le Quyen LeHanoi Oncology Hospital, Hanoi, Vietnam.
Thi Lan-Anh LuongHanoi Medical University Hospital, Hanoi Medical University, Hanoi, Vietnam.
Thi Kim Phuong DoanHanoi Medical University Hospital, Hanoi Medical University, Hanoi, Vietnam.
Thi Trang DaoHanoi Medical University Hospital, Hanoi Medical University, Hanoi, Vietnam.
Canh Duy PhanHue Central Hospital, Hue, Vietnam.
Thanh Xuan NguyenHue Central Hospital, Hue, Vietnam.
Nguyen Tuong PhamHue Central Hospital, Hue, Vietnam.
Bao Toan NguyenMedic Medical Center, Ho Chi Minh, Vietnam.
Thi Thu Thuy PhamMedic Medical Center, Ho Chi Minh, Vietnam.
Huu Linh LeMedic Medical Center, Ho Chi Minh, Vietnam.
Cong Thanh TruongMedic Medical Center, Ho Chi Minh, Vietnam.
Thanh Xuan JasmineMedic Medical Center, Ho Chi Minh, Vietnam.
Minh Chi LeUniversity Medical Center HCM, Ho Chi Minh, Vietnam.
Van Bau PhanPeople's Hospital 115, Ho Chi Minh, Vietnam.
Quang Binh TruongUniversity Medical Center HCM, Ho Chi Minh, Vietnam.
Thi Huong Ly TranCantho Oncology Hospital, Can Tho, Vietnam.
Minh Thien HuynhCantho Oncology Hospital, Can Tho, Vietnam.
Tu Quy TranDanang Oncology Hospital, Da Nang, Vietnam.
Si Tuan NguyenThong Nhat Dongnai General Hospital, Bien Hoa, Vietnam.
Vu TranThong Nhat Dongnai General Hospital, Bien Hoa, Vietnam.
Van Khanh TranLe Van Thinh Hospital, Ho Chi Minh, Vietnam.
Huu Nguyen NguyenMedical Genetics Institute, Ho Chi Minh, Vietnam.
Duy Sinh NguyenMedical Genetics Institute, Ho Chi Minh, Vietnam.
Thi Van PhanMedical Genetics Institute, Ho Chi Minh, Vietnam.
Thi Thanh-Thuy DoMedical Genetics Institute, Ho Chi Minh, Vietnam.
Dinh Kiet TruongMedical Genetics Institute, Ho Chi Minh, Vietnam.
Hung Sang TangMedical Genetics Institute, Ho Chi Minh, Vietnam.
Hoa GiangMedical Genetics Institute, Ho Chi Minh, Vietnam.
Hoai-Nghia NguyenMedical Genetics Institute, Ho Chi Minh, Vietnam.
Minh-Duy PhanMedical Genetics Institute, Ho Chi Minh, Vietnam. pmduy@yahoo.com.
Le Son TranMedical Genetics Institute, Ho Chi Minh, Vietnam. leson1808@gmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNon-invasive multi-cancer early detection (MCED) tests have shown promise in enhancing early cancer detection. However, their clinical utility across diverse populations remains underexplored, limiting their routine implementation. This study aims to validate the clinical utility of a multimodal non-invasive circulating tumor DNA (ctDNA)-based MCED test, SPOT-MAS (Screening for the Presence Of Tumor by DNA Methylation And Size).

methodsWe conducted a multicenter prospective study, K-DETEK (ClinicalTrials.gov identifier: NCT05227261), involving 9057 asymptomatic individuals aged 40 years or older across 75 major hospitals and one research institute in Vietnam. Participants were followed for 12 months.

resultsOf the 9024 eligible participants, 43 (0.48%) tested positive for ctDNA. Among these, 17 were confirmed with malignant lesions in various primary organs through standard-of-care (SOC) imaging and biopsy, with 9 cases matching our tissue of origin (TOO) predictions. This resulted in a positive predictive value of 39.53% (95%CI 26.37-54.42) and a TOO accuracy of 52.94% (95%CI 30.96-73.83). Among the 8981 participants (99.52%) who tested negative, 8974 were confirmed cancer-free during a 12-month period after testing, yielding a negative predictive value of 99.92% (95% CI 99.84-99.96). The test demonstrated an overall sensitivity of 70.83% (95%CI 50.83-85.09) and a specificity of 99.71% (95% CI 99.58-99.80) for detecting various cancer types, including those without SOC screening options.

conclusionsThis study presents a prospective validation of a multi-cancer early detection (MCED) test conducted in a lower middle-income country, demonstrating the potential of SPOT-MAS for early cancer detection. Our findings indicate that MCED tests could be valuable additions to national cancer screening programs, particularly in regions where such initiatives are currently limited.

trial registrationClinicalTrials.gov ID: NCT05227261. Date of registration: 07/02/2022.

Indexed as

Circulating Tumor DNAEarly Detection of CancerNeoplasmsAdultAgedBiomarkers, TumorFemaleHumansMaleMiddle AgedProspective StudiesVietnamBiomarkers, TumorCirculating Tumor DNAClinical validationLiquid biopsyMulticancer early detectionMultimodal analysisTissue of origin

Identifiers

PMID39948555
PMCPMC11827191

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.