Clinical trial · Observational
Early Detection of Five Common Cancers Using the ctDNA Analysing Test
Assessment of a Novel Blood Test in Early Detection of the Five Common Cancers Based on the Investigation of the Circulating Tumour DNA
NCT05227261CI-TRIAL-00086163K-DETEKcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multi-centre, prospective cohort study, aiming to evaluate a blood test in early detection of the four common cancers, based on the investigation of the circulating tumour DNA (ctDNA). Primary objective: To evaluate the performance characteristics of the blood ctDNA test in early detecting cancers. Secondary objectives: * To evaluate the performance characteristics of the test in determining the origin of tumour, as compared to the findings of the imaging diagnostic tests. * To determine the risk of cancers development in the high-risk population, as compared to that in the moderate-risk group.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer, Breast | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer, Colorectal | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Cancer, Gastric | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Cancer Liver | — | UNRESOLVED | — |
| Cancer, Lung | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Circulating Tumour DNA | — | UNRESOLVED | — |
| Liquid Biopsy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Positive predictive value, Negative predictive value of the blood ctDNA test in early detecting cancers
- timeFrame
- 12 months following enrolment
- measure
- Sensitivity and specificity of the test in early detecting cancers
- timeFrame
- 12 months following enrolment
Secondary outcomes (2)
- measure
- Positive predictive value of the test in determining the origin of tumour, as compared to the findings of the imaging diagnostic tests
- timeFrame
- 12 months following enrolment
- measure
- Rate of cancer development in the high-risk group as compared to the moderate-risk population
- timeFrame
- 12 months following enrolment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 40 or above at enrolment * Neither clinical suspicion of cancer nor history of confirmed cancer has been reported * Agree to be contacted at 6 months and 12 months following enrolment to collect information about general health status and progress of cancer (if possible) * Provide written informed consent Exclusion Criteria: If a potential participant has any one of the following criteria, he/she will not be able to be enrolled in the study: * History of cancer (cancer has either been confirmed or been treated within the past 3 years) * History of blood transfusion or bone marrow transplantation within the past 3 years * Does not agree to participate in study * The subject has clinical manifestations of pregnant.
References
Publications (64)
- BACKGROUNDSung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
- BACKGROUNDBray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. PMID 30207593
- BACKGROUNDPham T, Bui L, Kim G, Hoang D, Tran T, Hoang M. Cancers in Vietnam-Burden and Control Efforts: A Narrative Scoping Review. Cancer Control. 2019 Jan-Dec;26(1):1073274819863802. doi: 10.1177/1073274819863802. PMID 31319695
- BACKGROUNDAhlquist DA. Universal cancer screening: revolutionary, rational, and realizable. NPJ Precis Oncol. 2018 Oct 29;2:23. doi: 10.1038/s41698-018-0066-x. eCollection 2018. PMID 30393772
- BACKGROUNDBrenner H, Jansen L, Ulrich A, Chang-Claude J, Hoffmeister M. Survival of patients with symptom- and screening-detected colorectal cancer. Oncotarget. 2016 Jul 12;7(28):44695-44704. doi: 10.18632/oncotarget.9412. PMID 27213584
- BACKGROUNDNational Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29. PMID 21714641
- BACKGROUNDTabar L, Fagerberg G, Chen HH, Duffy SW, Smart CR, Gad A, Smith RA. Efficacy of breast cancer screening by age. New results from the Swedish Two-County Trial. Cancer. 1995 May 15;75(10):2507-17. doi: 10.1002/1097-0142(19950515)75:103.0.co;2-h.