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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02751177

Acronym

ColoBEAM

Enrollment

236

Registered

2016-04-26

Start date

2016-03-25

Completion date

2017-05-30

Last updated

2018-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer Metastatic

Keywords

KRAS gene mutation, NRAS gene mutation, BRAF gene mutation

Brief summary

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

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.

Interventions

GENETICKRAS, NRAS et BRAF mutation analysis from circulating plasma DNA

Mutation in plasma DNA vs tumor tissue

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
KRAS, NRAS et BRAF mutational status	up to 6 months	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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026