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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-25

Study Completion Date

2017-05-30

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.

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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.

Conditions

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Colorectal Cancer Metastatic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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OncoBEAM

KRAS, NRAS and BRAF mutations will be analyzed in circulating plasma DNA using ONCOBEAM technique.

Group Type EXPERIMENTAL

KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA

Intervention Type GENETIC

Mutation in plasma DNA vs tumor tissue

Interventions

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KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA

Mutation in plasma DNA vs tumor tissue

Intervention Type GENETIC

Other Intervention Names

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metastatic colorectal cancer OncoBEAM

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No