Skip to main content
OpenTrials
Completed

NCT Number: NCT02751177

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Auxerre, Auxerre, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA

Genetic

Mutation in plasma DNA vs tumor tissue

Other names: metastatic colorectal cancer, OncoBEAM

Primary outcomes

  1. KRAS, NRAS et BRAF mutational status

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Official study title

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

Acronym: ColoBEAM

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 26, 2016
Registry last updated
Aug 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.