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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer Metastatic
• Intervention / Treatment: Genetic: KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA

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 Type: Interventional
• Enrollment (Actual): 236
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Auxerre, France, 89000
    • Ch Auxerre
  • Besançon, France, 25020
    • CH Besançon-Hopital Jean Minjoz
  • Chalon Sur Saône, France, 71 321
    • CH Chalon Sur Saône-William Morey
  • Dijon, France, 21079
    • Centre Georges Francois Leclerc Dijon
  • Metz, France, 54045
    • Hopital Belle-Isle-Metz
  • Nancy, France, 54000
    • Polyclinique de Gentilly
  • Reims, France, 51100
    • Polyclinique Courlancy Reims
  • Reims, France, 51092
    • CHU Reims-Hôpital Robert Debré
  • Strasbourg, France, 67065
    • Centre Paul Stauss
  • Vandœuvre-lès-Nancy, France, 54500
    • CHRU Nancy
  • Vandœuvre-lès-Nancy, France, 54519
    • Institut de Cancérologie de Lorraine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OncoBEAM; 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; Mutation in plasma DNA vs tumor tissue; Other Names: metastatic colorectal cancer; OncoBEAM

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institut de Cancérologie de Lorraine
• Investigators: Study Chair: HARLE ALEXANDRE, Institut de Cancérologie de Lorraine; Study Chair: MERLIN JEAN LOUIS, Institut de Cancérologie de Lorraine; Principal Investigator: GAVOILLE CELINE, oncologist, Institut de Cancérologie de Lorraine

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2016
• Primary Completion (Actual): May 30, 2017
• Study Completion (Actual): May 30, 2017

Study Registration Dates

• First Submitted: March 3, 2016
• First Submitted That Met QC Criteria: April 21, 2016
• First Posted (Estimate): April 26, 2016

Study Record Updates

• Last Update Posted (Actual): August 9, 2018
• Last Update Submitted That Met QC Criteria: August 7, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: KRAS gene mutation; NRAS gene mutation; BRAF gene mutation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2015-A01272-47

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES