Clinical trial · Interventional
Detection of KRAS, NRAS et BRAF Mutations in Plasma Circulating DNA From Patients With Metastatic Colorectal Cancer
Multicenter Prospective Study Comparing KRAS, NRAS and BRAF Mutation Testing Using OncoBEAM Technique in Plasma vs Conventional Techniques in Formalin Fixed Paraffin Embedded Tissues
- 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)
RAS genotyping is mandatory for the prescription of anti-EGFR (epidermal growth factor receptor) therapies in patients with metastatic colorectal cancer. The standard genotyping is assessed on formalin-fixed paraffin embedded tumour tissue. This study compares RAS and BRAF genotyping results achieved in analyzing circulating plasma DNA using OncoBEAM™ technique with those achieved using the standard genotyping techniques and formalin-fixed paraffin embedded samples.
Conditions
Conditions (1)
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 Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OncoBEAM
- description
- KRAS, NRAS and BRAF mutations will be analyzed in circulating plasma DNA using ONCOBEAM technique.
- interventionNames
- Genetic: KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA
Primary outcomes (1)
- measure
- KRAS, NRAS et BRAF mutational status
- timeFrame
- up to 6 months
- description
- Compare the results of KRAS (exons 2, 3 et 4), NRAS (exons 2, 3 et 4) and BRAF (V600) genes genotyping using OncoBeam technique in blood samples with results achieved routinely by the molecular genetics platforms of the recruiting centers.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult subjects with newly diagnosed, anti EGFR treatment naïve metastatic colorectal cancer * Standard of Care RAS/RAF tests performed on FFPE tumor sample as part of routine * Patient information and written informed consent form signed * Patient must be affiliated to a social security system * Age : 18 years and older Exclusion Criteria: * Patient bearing non-metastatic colorectal cancer * Patient with local relapse only * Patient with exclusive nodal metastases * Patient whose health contraindicates a 30 ml blood sample * Blood transfusion within 1 week prior blood collection * Patient having received any chemotherapy or / and radiotherapy within 15 days prior to blood collection * History of another primary cancer within the last 5 years, with the exception of non-melanomatous skin cancer and carcinoma in situ of the cervix * Persons deprived of liberty or under supervision
References
Publications (1)
- DERIVEDHarle A, Gavoille C, Bouche O, Abdelghani MB, Plaza J, Spaeth D, Boudrant A, Ghiringhelli F, Villing AL, Borg C, Rouyer M, Husson M, Gilson P, Salleron J, Lambert A, Merlin JL. Sensitive cell-free DNA assay for accurate detection of RAS and BRAF mutations in liquid biopsies of patients with metastatic colorectal cancer: Final results of the multicentric ColoBEAM study. Oncol Lett. 2025 Oct 30;31(1):13. doi: 10.3892/ol.2025.15366. eCollection 2026 Jan. PMID 41235357