Detection of KRAS, NRAS et BRAF Mutations in Plasma Circulating DNA From Patients With Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Multicenter Prospective Study Comparing KRAS, NRAS and BRAF Mutation Testing Using OncoBEAM Technique in Plasma vs Conventional Techniques in Formalin Fixed Paraffin Embedded Tissues

Conditions
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Colorectal Cancer Metastatic

Intervention / Treatment
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* Genetic: KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OncoBEAM<br>KRAS, NRAS and BRAF mutations will be analyzed in circulating plasma DNA using ONCOBEAM technique. | Genetic: KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA<br>* Mutation in plasma DNA vs tumor tissue<br>* Other names: OncoBEAM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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KRAS gene mutation, NRAS gene mutation, BRAF gene mutation