The analysis of circulating DNA (Deoxyribonucleic acid) to identify potential resistance mechanisms during anti-EGFR (epidermal growth factor receptor) treatment is of great interest, as evidenced by the recent journal published by Corcoran in the prestigious New England Journal of Medicine. EmutRAS is one of the first studies that will specifically and prospectively evaluate the RAS mutational switch and its impact on the efficiency of the 1st line processing.
The primary study objective is the Detection of RAS mutational (rat sarcoma viral oncogene homolog) "switch" in circulating DNA by Intplex® test in mCRC (metastatic colorectal cancer) patients treated with antibody anti-EGFR (epidermal growth factor receptor), cetuximab or panitumumab in first line. The treatment and these modalities will be decided by the investigator. The study is based on blood sampling, the frequency of which is described below, rhythm of plasma samples: Inclusion after determination of wild status RAS tissues. First sampling of 2 EDTA (ethylenediaminetetraacetic acid) tubes, then at each tumour evaluation during treatment with anti EGFR (epidermal growth facor receptor), every 4 cures. At the end of treatment or after more than 36 treatment cures, a final sample will be taken. No results of the samples will be communicated to the investigator, the sponsor will centralize these results for the final analysis of the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
130
Blood sample at each tumor assessment
ICM Val d'Aurelle
Montpellier, Montpellier, France
Institut du Cancer de Montpellier - Val d'Aurelle
Montpellier, France
Proportion of patients with mCRC (metastatic colorectal cancer) who develop a RAS (rat sarcoma viral oncogene homolog) mutation under anti-EGFR (epidermal growth factor receptor) therapy
From baseline to the end of treatment
Time frame: Approximately 8 weeks
Probability of obtaining a positive test, i.e. RAS status mutated by the Intplex® test, among the patients determined RAS mutated by the tissue test
From baseline to the end of treatment
Time frame: Approximately 8 weeks
Probability of obtaining a negative test, i.e. wild RAS status by the Intplex® test among patients determined wild RAS by the tissue test
From baseline to the end of treatment
Time frame: Approximately 8 weeks
Probability of obtaining a positive test, i.e. BRAF status mutated by the Intplex® test, among the patients determined BRAF mutated by the tissue test
From baseline to the end of treatment
Time frame: Approximately 8 weeks
Probability of obtaining a negative test, i.e. wild BRAF status by Intplex® test among patients determined wild BRAF by tissue test.compared to the pre-treatment tissue test
From baseline to the end of treatment
Time frame: Approximately 8 weeks
Proportion of patients with a BRAF mutation under anti-EGFR therapy
From baseline to the end of treatment
Time frame: Approximately 8 weeks
Progression-free survival
From baseline to the database cutoff
Time frame: Approximately 36 months
Global survival
From baseline to the database cutoff
Time frame: Approximately 36 months
Evaluation of the following criterion: total concentration of circulating DNA
From baseline to the end of treatment
Time frame: Approximately 8 weeks
Evaluation of the following criterion: integrity index
From baseline to the end of treatment
Time frame: Approximately 8 weeks
Evaluation of the following criterion: concentration of mutated alleles
From baseline to the end of treatment
Time frame: Approximately 8 weeks
Evaluation of the following criterion: frequency of mutated alleles
From baseline to the end of treatment
Time frame: Approximately 8 weeks
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