Clinical trial · Interventional
Smart Measurement of Circulating Tumor DNA
Smart Measurement of Circulating Tumor DNA: a Tumor-agnostic Computational Tool to Improve Colorectal Cancer Care
NCT06989814CI-TRIAL-00093411SMARTrecruitingN/AClinicalTrials.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)
The goal of this study is to develop a blood-test which can detect colorectal cancer in early stages. Participants will be asked to take an extra blood test, which will be analyzed further in the lab.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Colorectal Neoplasms, Hereditary Nonpolyposis | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.85 |
| Colorectal Neoplasms Malignant | — | UNRESOLVED | — |
| Hereditary Nonpolyposis Colon Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Product | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lynch-carriers with a (colorectal) tumor
- description
- People with a newly diagnosed Lynch-associated tumor will be asked to undergo an extra blood test.
- interventionNames
- Diagnostic Test: Blood Product
Primary outcomes (2)
- measure
- Estimated ctDNA fractions in blood
- timeFrame
- Measurement at baseline
- description
- ctDNA presence will be measured against a (presently not specified) threshold, creating a divide between 'detectable' and 'non-detectable'.
- measure
- Tumor pathology
- timeFrame
- Measurement at baseline
- description
- Tumor pathology will be revised to later compare with estimated ctDNA presence.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: (suspect) Lynch Syndrome carriers who: * Have proven Lynch Syndrome (MMR-gene or EPCAM mutation), or have a proven microsatellite instability high (MSI-H)tumor; * Are at least 18 years old; Have been diagnosed with any form of cancer at the time of inclusion, but have had no treatment yet; * Have granted informed consent to participate in this study. Exclusion Criteria: (suspect) Lynch Syndrome carriers who: * Are unwilling to undergo extra blood sampling; * Are under the age of 18; * Have no newly diagnosed tumors at time of inclusion; * Have been treated for their tumor at time of inclusion; * Are not able to read or understand Dutch language or are mentally not capable.
References
Publications (4)
- BACKGROUNDMouliere F, Chandrananda D, Piskorz AM, Moore EK, Morris J, Ahlborn LB, Mair R, Goranova T, Marass F, Heider K, Wan JCM, Supernat A, Hudecova I, Gounaris I, Ros S, Jimenez-Linan M, Garcia-Corbacho J, Patel K, Ostrup O, Murphy S, Eldridge MD, Gale D, Stewart GD, Burge J, Cooper WN, van der Heijden MS, Massie CE, Watts C, Corrie P, Pacey S, Brindle KM, Baird RD, Mau-Sorensen M, Parkinson CA, Smith CG, Brenton JD, Rosenfeld N. Enhanced detection of circulating tumor DNA by fragment size analysis. Sci Transl Med. 2018 Nov 7;10(466):eaat4921. doi: 10.1126/scitranslmed.aat4921. PMID 30404863
- BACKGROUNDDeger T, Boers RG, de Weerd V, Angus L, van der Put MMJ, Boers JB, Azmani Z, van IJcken WFJ, Grunhagen DJ, van Dessel LF, Lolkema MPJK, Verhoef C, Sleijfer S, Martens JWM, Gribnau J, Wilting SM. High-throughput and affordable genome-wide methylation profiling of circulating cell-free DNA by methylated DNA sequencing (MeD-seq) of LpnPI digested fragments. Clin Epigenetics. 2021 Oct 20;13(1):196. doi: 10.1186/s13148-021-01177-4. PMID 34670587
- BACKGROUNDSchrag D, Beer TM, McDonnell CH 3rd, Nadauld L, Dilaveri CA, Reid R, Marinac CR, Chung KC, Lopatin M, Fung ET, Klein EA. Blood-based tests for multicancer early detection (PATHFINDER): a prospective cohort study. Lancet. 2023 Oct 7;402(10409):1251-1260. doi: 10.1016/S0140-6736(23)01700-2. PMID 37805216
- RESULTEikenboom EL, Wilting SM, Deger T, Srebniak MI, Van Veghel-Plandsoen M, Boers RG, Boers JB, van IJcken WFJ, Gribnau JH, Atmodimedjo P, Dubbink HJ, Martens JWM, Spaander MCW, Wagner A. Liquid Biopsies for Colorectal Cancer and Advanced Adenoma Screening and Surveillance: What to Measure? Cancers (Basel). 2023 Sep 17;15(18):4607. doi: 10.3390/cancers15184607. PMID 37760576