RAS Mutation Testing in the Circulating Blood of Patients With Metastatic Colorectal Cancer (RASANC)

November 16, 2016 updated by: Association des Gastroentérologues Oncologues

RAS Mutation Testing in the Circulating Blood of Patients With Metastatic Colorectal Cancer: Concordance With the "Standard" Testing Method From Tumor Tissue and Review of Associated Timelines and Costs

This study will evaluate the concordance of RAS mutation detection between the results obtained from circulating tumor DNA and those obtained with the "standard" method (testing from tumor tissue).

Study Overview

Status

Unknown

Conditions

Colorectal Cancer

Study Type

Observational

Enrollment (Anticipated)

425

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Bobigny, France
    - Recruiting
    - Hopital Avicenne
    - Contact:
      
      Thomas Aparicio, Pr
  - Clamart, France
    - Recruiting
    - Hôpital Béclère
    - Contact:
      
      L Marthey, Dr
  - Creteil, France
    - Recruiting
    - Hopital Henri Mondor
    - Contact:
      
      Christophe Tournigand, Pr
  - Kremlin-Bicêtre, France
    - Recruiting
    - Hôpital Kremlin-Bicêtre
    - Contact:
      
      Anne Thirot- Bidault, Dr
  - Longjumeau, France
    - Recruiting
    - CH Longjumeau et Sud
    - Contact:
      
      J Ezenfis, Dr
  - Lyon, France
    - Recruiting
    - Hopital Mermoz
    - Contact:
      
      Gérard Lledo, Dr
  - Paris, France
    - Recruiting
    - Hôpital Saint-Antoine
    - Contact:
      
      Thierry André, Pr
  - Paris, France
    - Recruiting
    - Hôpital Europeén Georges Pompidou
    - Contact:
      
      Julien TAIEB, Pr
  - Paris, France
    - Recruiting
    - Hôpital Cochin
    - Contact:
      
      Romain Coriat, Pr
  - Paris, France
    - Recruiting
    - Hôpital Saint-Louis
    - Contact:
      
      Jean-Marc Gornet, Dr
  - Paris, France
    - Recruiting
    - Hôpital Pitie Salpétrière
    - Contact:
      
      Jean-Baptiste Bachet, Dr
  - Poitiers, France
    - Recruiting
    - CHU Poitiers
    - Contact:
      
      DAVID TOUGERON, PR
  - Reims, France
    - Recruiting
    - CHU Robert Debre
  - Tours, France
    - Recruiting
    - Hôpital TROUSSEAU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All treatment naive patients seen in consultation for metastatic colorectal cancer in the participating centers

Description

Inclusion Criteria:

Pathologically confirmed metachronous or synchronous metastatic colorectal cancer
No prior chemotherapy with the exception of adjuvant chemotherapy completed ≥ 6 months prior to enrollment
Signed written informed consent obtained prior to any study specific screening procedures
Patients willing to provide a blood sample for Translational Research

Exclusion Criteria:

No tumor block available
Previous malignancy in the last 5 years
Medical, sociological, psychological or legal conditions that would not permit the patient to sign informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance regarding the mutation of RAS (yes vs no, dichotomous variable) between the two methods Time Frame: Baseline	RAS mutations will be compared between tumor tissue (standard testing methods) and results obtained from circulating tumor DNA	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance regarding the mutation of RAS (yes vs no, dichotomous variable) between the two methods in patients for whom circulating tumor DNA has been identified in the avalaible plasma sample. Time Frame: Baseline	RAS mutations will be compared between tumor tissue (standard testing methods) and results obtained from circulating tumor DNA. This subgroup of patients is defined as patients with at least one mutation identified in the panel of tested genes (Ion AmpliSeq Colon and Lung Cancer Panel) (RAS mutation or mutations on other genes TP53, PIK3CA, SMAD4 .... ) or with at least one methylated biomarker identified (for patients with no mutation identified in the panel of genes tested).	Baseline
Comparison of the timelines to obtain results between the two methods Time Frame: Baseline	Timelines to obtain RAS mutations will be compared between tumor tissue (standard testing methods) and circulating tumor DNA	Baseline
Comparisons of the costs between the two methods Time Frame: Baseline	Costs for the two methods will be compared between tumor tissue (standard testing methods) and circulating tumor DNA	Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association des Gastroentérologues Oncologues

Investigators

Principal Investigator: Jean-Baptiste Bachet, Dr, Association des Gastro-entérologues Oncologues (AGEO)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Bachet JB, Bouche O, Taieb J, Dubreuil O, Garcia ML, Meurisse A, Normand C, Gornet JM, Artru P, Louafi S, Bonnetain F, Thirot-Bidault A, Baumgaertner I, Coriat R, Tougeron D, Lecomte T, Mary F, Aparicio T, Marthey L, Taly V, Blons H, Vernerey D, Laurent-Puig P. RAS mutation analysis in circulating tumor DNA from patients with metastatic colorectal cancer: the AGEO RASANC prospective multicenter study. Ann Oncol. 2018 May 1;29(5):1211-1219. doi: 10.1093/annonc/mdy061.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

July 16, 2015

First Submitted That Met QC Criteria