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

• Conditions: Colorectal Cancer

• Registration Number: NCT02502656
• Lead Sponsor: Association des Gastroentérologues Oncologues

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-16
• Study First Submitted QC: 2015-07-16
• Study First Posted: 2015-07-20
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-17
• Primary Completion: 2017-08
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 425

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.	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).
Comparison of the timelines to obtain results between the two methods	Baseline	Timelines to obtain RAS mutations will be compared between tumor tissue (standard testing methods) and circulating tumor DNA
Comparisons of the costs between the two methods	Baseline	Costs for the two methods will be compared between tumor tissue (standard testing methods) and circulating tumor DNA

Trial Locations

Locations (14)

Hôpital Avicenne; 🇫🇷 Bobigny, France

Hopital Béclère; 🇫🇷 Clamart, France

Hopital Henri Mondor; 🇫🇷 Creteil, France

Hopital Kremlin-Bicêtre; 🇫🇷 Kremlin-Bicêtre, France

CH Longjumeau et Sud; 🇫🇷 Longjumeau, France

Hopital Saint-Antoine; 🇫🇷 Paris, France

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France

Hopital Mermoz; 🇫🇷 Lyon, France

Hôpital Pitié Salpêtrière; 🇫🇷 Paris, France

CHU Poitiers; 🇫🇷 Poitiers, France

Hopital Cochin; 🇫🇷 Paris, France

Hopital Saint-Louis; 🇫🇷 Paris, France

CHU Robert Debré; 🇫🇷 Reims, France

Hôpital Trousseau; 🇫🇷 Tours, France