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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.
The study will be proposed to all patients with a metastatic colorectal cancer.
Study information will be given to the patient during a routine medical examination. The patient will be included after checking inclusion criteria and signature of the informed consent form
Blood sampling (30 ml) will be performed before the initiation of the first line metastatic chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OncoBEAM | Experimental | KRAS, NRAS and BRAF mutations will be analyzed in circulating plasma DNA using ONCOBEAM technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA | Genetic | Mutation in plasma DNA vs tumor tissue |
|
| Measure | Description | Time Frame |
|---|---|---|
| KRAS, NRAS et BRAF mutational status | 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. | up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MERLIN JEAN LOUIS | Institut de Cancérologie de Lorraine | Study Chair |
| HARLE ALEXANDRE | Institut de Cancérologie de Lorraine | Study Chair |
| GAVOILLE CELINE, oncologist | Institut de Cancérologie de Lorraine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Auxerre | Auxerre | 89000 | France | |||
| CH Besançon-Hopital Jean Minjoz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41235357 | Derived | Harle 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. |
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| Besançon |
| 25020 |
| France |
| CH Chalon Sur Saône-William Morey | Chalon-sur-Saône | 71 321 | France |
| Centre Georges François Leclerc Dijon | Dijon | 21079 | France |
| Hopital Belle-Isle-Metz | Metz | 54045 | France |
| Polyclinique de Gentilly | Nancy | 54000 | France |
| CHU Reims-Hôpital Robert Debré | Reims | 51092 | France |
| Polyclinique Courlancy Reims | Reims | 51100 | France |
| Centre Paul Stauss | Strasbourg | 67065 | France |
| CHRU Nancy | Vandœuvre-lès-Nancy | 54500 | France |
| Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | 54519 | France |