Clinical trial NCT02751177: Detection of KRAS, NRAS et BRAF Mutations in Plasma Circulating DNA From Patients With Metastatic Colorectal Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer Metastatic
Keywords: KRAS gene mutation
NRAS gene mutation
BRAF gene mutation
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2016-04-26
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: KRAS, NRAS et BRAF mutational status
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Auxerre
country: France
facility: CH Auxerre
city: Besançon
country: France
facility: CH Besançon-Hopital Jean Minjoz
city: Chalon Sur Saône
country: France
facility: CH Chalon Sur Saône-William Morey
city: Dijon
country: France
facility: Centre Georges François Leclerc Dijon
city: Metz
country: France
facility: Hopital Belle-Isle-Metz
city: Nancy
country: France
facility: Polyclinique de Gentilly
city: Reims
country: France
facility: CHU Reims-Hôpital Robert Debré
city: Reims
country: France
facility: Polyclinique Courlancy Reims
city: Strasbourg
country: France
facility: Centre Paul Stauss
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Nancy
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: MERLIN JEAN LOUIS
role: STUDY_CHAIR
affiliation: Institut de Cancérologie de Lorraine
name: HARLE ALEXANDRE
role: STUDY_CHAIR
affiliation: Institut de Cancérologie de Lorraine
name: GAVOILLE CELINE, oncologist
role: PRINCIPAL_INVESTIGATOR
References: