NCT02751177

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 236 (actual)
• Sponsor: Institut de Cancérologie de Lorraine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
GENETIC	KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA	Mutation in plasma DNA vs tumor tissue

Timeline

• Start date: 2016-03-25
• Primary completion: 2017-05-30
• Completion: 2017-05-30
• First posted: 2016-04-26
• Last updated: 2018-08-09

Locations

11 sites across 1 country: France