Clinical trial · Observational
Liquid Biopsy and Machine Learning for Early Colorectal Cancer, Adenomas, Lynch Cancers, and Residual Disease Detection
NCT07450612CI-TRIAL-00104583BEACONrecruitingClinicalTrials.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 an multicenter study that will test the diagnostic accuracy of a blood test (i.e., a liquid biopsy) for the diagnosis of colorectal cancer (CRC), advanced adenomas (AAs), as well as Lynch-syndrome associated cancers. Additionally, a pre-planned analysis will evaluate the use of this liquid biopsy as a tool for molecular residual disease monitoring purposes.
Conditions
Conditions (19)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoma Colon | — | UNRESOLVED | — |
| Adenoma Colon Polyp | — | UNRESOLVED | — |
| Colon Adenoma | Colon Adenoma | ONTOLOGY_EXACT | 0.98 |
| Colon Disease | — | UNRESOLVED | — |
| Colon Neoplasm | Colon Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Colo-rectal Cancer | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| EPCAM Gene Mutation | — | UNRESOLVED | — |
| Lynch Syndrome | — | UNRESOLVED | — |
| Lynch Syndrome I | — | UNRESOLVED | — |
| Lynch Syndrome II | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BEACON | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- label
- Lynch syndrome, without Lynch-syndrome associated cancers
- description
- Individuals with Lynch syndrome, who are free of Lynch-syndrome associated cancers at the time of blood drawing
- interventionNames
- Diagnostic Test: BEACON
- label
- Lynch syndrome, with Lynch-syndrome associated cancers
- description
- Individuals with Lynch syndrome, who have one (or more) Lynch-syndrome associated cancer(s) at the time of blood drawing
- interventionNames
- Diagnostic Test: BEACON
- label
- Colorectal cancer
- description
- Individuals with sporadic biopsy-proven colorectal cancer, as identified during routine colonoscopy and diagnosed via pathological review
- interventionNames
- Diagnostic Test: BEACON
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All individuals included in the study need to have had a colonoscopy at the time of blood sampling. * Received standard diagnostic and staging (as necessary) procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment. * Received standard pathological and endoscopic diagnosis and assessment for cohort assignment Exclusion Criteria: * Lack of informed consent * Inflammatory bowel disease
References
Publications (21)
- BACKGROUNDAhlquist DA, Sargent DJ, Loprinzi CL, Levin TR, Rex DK, Ahnen DJ, Knigge K, Lance MP, Burgart LJ, Hamilton SR, Allison JE, Lawson MJ, Devens ME, Harrington JJ, Hillman SL. Stool DNA and occult blood testing for screen detection of colorectal neoplasia. Ann Intern Med. 2008 Oct 7;149(7):441-50, W81. doi: 10.7326/0003-4819-149-7-200810070-00004. PMID 18838724
- BACKGROUNDAziz Z, Wagner S, Agyekum A, Pumpalova YS, Prest M, Lim F, Rustgi S, Kastrinos F, Grady WM, Hur C. Cost-Effectiveness of Liquid Biopsy for Colorectal Cancer Screening in Patients Who Are Unscreened. JAMA Netw Open. 2023 Nov 1;6(11):e2343392. doi: 10.1001/jamanetworkopen.2023.43392. PMID 37971743
- BACKGROUNDBarnell EK, Kang Y, Wurtzler EM, Griffith M, Chaudhuri AA, Griffith OL; Geneoscopy Scientists. Noninvasive Detection of High-Risk Adenomas Using Stool-Derived Eukaryotic RNA Sequences as Biomarkers. Gastroenterology. 2019 Sep;157(3):884-887.e3. doi: 10.1053/j.gastro.2019.05.058. Epub 2019 May 30. No abstract available. PMID 31154021
- BACKGROUNDBarnell EK, Wurtzler EM, La Rocca J, Fitzgerald T, Petrone J, Hao Y, Kang Y, Holmes FL, Lieberman DA. Multitarget Stool RNA Test for Colorectal Cancer Screening. JAMA. 2023 Nov 14;330(18):1760-1768. doi: 10.1001/jama.2023.22231. PMID 37870871
- BACKGROUNDBettegowda C, Sausen M, Leary RJ, Kinde I, Wang Y, Agrawal N, Bartlett BR, Wang H, Luber B, Alani RM, Antonarakis ES, Azad NS, Bardelli A, Brem H, Cameron JL, Lee CC, Fecher LA, Gallia GL, Gibbs P, Le D, Giuntoli RL, Goggins M, Hogarty MD, Holdhoff M, Hong SM, Jiao Y, Juhl HH, Kim JJ, Siravegna G, Laheru DA, Lauricella C, Lim M, Lipson EJ, Marie SK, Netto GJ, Oliner KS, Olivi A, Olsson L, Riggins GJ, Sartore-Bianchi A, Schmidt K, Shih lM, Oba-Shinjo SM, Siena S, Theodorescu D, Tie J, Harkins TT, Veronese S, Wang TL, Weingart JD, Wolfgang CL, Wood LD, Xing D, Hruban RH, Wu J, Allen PJ, Schmidt CM, Choti MA, Velculescu VE, Kinzler KW, Vogelstein B, Papadopoulos N, Diaz LA Jr. Detection of circulating tumor DNA in early- and late-stage human malignancies. Sci Transl Med. 2014 Feb 19;6(224):224ra24. doi: 10.1126/scitranslmed.3007094.