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

Colorectal Cancer Metastatic Clinical Trial

— ColoBEAM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02751177
• Other study ID #: 2015-A01272-47
• Status: Completed
• Phase: N/A
• Start date: March 25, 2016
• Est. completion date: May 30, 2017

Study information

• Verified date: August 2018
• Source: Institut de Cancérologie de Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: May 30, 2017
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

Intervention

Genetic:
• KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA
Mutation in plasma DNA vs tumor tissue

Locations

Country	Name	City	State
France	CH Auxerre	Auxerre
France	CH Besançon-Hopital Jean Minjoz	Besançon
France	CH Chalon Sur Saône-William Morey	Chalon Sur Saône
France	Centre Georges François Leclerc Dijon	Dijon
France	Hopital Belle-Isle-Metz	Metz
France	Polyclinique de Gentilly	Nancy
France	CHU Reims-Hôpital Robert Debré	Reims
France	Polyclinique Courlancy Reims	Reims
France	Centre Paul Stauss	Strasbourg
France	CHRU Nancy	Vandœuvre-lès-Nancy
France	Institut de Cancérologie de Lorraine	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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