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

I

Institut de Cancérologie de Lorraine

Status

Completed

Conditions

Colorectal Cancer Metastatic

Treatments

Genetic: KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA

Study type

Interventional

Funder types

Other

Identifiers

NCT02751177
2015-A01272-47

Details and patient eligibility

About

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.

Full 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.

Enrollment

236 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

236 participants in 1 patient group

OncoBEAM
Experimental group
Description:
KRAS, NRAS and BRAF mutations will be analyzed in circulating plasma DNA using ONCOBEAM technique.
Treatment:
Genetic: KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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