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

Association des Gastroentérologues Oncologues425 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

425

Conditions

Colorectal Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (14)

Hôpital Avicenne

Bobigny, France

RECRUITING

Hopital Béclère

Clamart, France

RECRUITING

Outcomes

Primary Outcomes

Concordance regarding the mutation of RAS (yes vs no, dichotomous variable) between the two methods

RAS mutations will be compared between tumor tissue (standard testing methods) and results obtained from circulating tumor DNA

Time frame: Baseline

Secondary Outcomes

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.

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).

Time frame: Baseline

Comparison of the timelines to obtain results between the two methods

Timelines to obtain RAS mutations will be compared between tumor tissue (standard testing methods) and circulating tumor DNA

Time frame: Baseline

Comparisons of the costs between the two methods

Costs for the two methods will be compared between tumor tissue (standard testing methods) and circulating tumor DNA

Time frame: Baseline

Central Contacts

Jean-Baptiste Bachet, Dr

CONTACT

jean-baptiste.bachet@psl.aphp.fr

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.