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

Not Applicable

Completed

• Conditions: Colorectal Cancer Metastatic
• Interventions: Genetic: KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA

• Registration Number: NCT02751177
• Lead Sponsor: Institut de Cancérologie de Lorraine

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.

Study Timeline

• Study First Submitted: 2016-03-03
• Study Start: 2016-03-25
• Study First Submitted QC: 2016-04-21
• Study First Posted: 2016-04-26
• Primary Completion: 2017-05-30
• Study Completion: 2017-05-30
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OncoBEAM	KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA	KRAS, NRAS and BRAF mutations will be analyzed in circulating plasma DNA using ONCOBEAM technique.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (11)

Polyclinique de Gentilly; 🇫🇷 Nancy, France

CH Auxerre; 🇫🇷 Auxerre, France

CH Chalon Sur Saône-William Morey; 🇫🇷 Chalon Sur Saône, France

CH Besançon-Hopital Jean Minjoz; 🇫🇷 Besançon, France

Centre Georges François Leclerc Dijon; 🇫🇷 Dijon, France

Hopital Belle-Isle-Metz; 🇫🇷 Metz, France

CHU Reims-Hôpital Robert Debré; 🇫🇷 Reims, France

CHRU Nancy; 🇫🇷 Vandœuvre-lès-Nancy, France

Polyclinique Courlancy Reims; 🇫🇷 Reims, France

Centre Paul Stauss; 🇫🇷 Strasbourg, France

Institut de Cancérologie de Lorraine; 🇫🇷 Vandœuvre-lès-Nancy, France