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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intplex test | Experimental | In vitro diagnostic device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intplex test | Device | Blood sample at each tumor assessment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Approximately 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Participation in another interventional clinical trial - biomedical research (therapeutic strategy type) is not excluded provided that it is use an Anti-EGFR with a AMM (marketing authorization), (Cetuximab - Panitumumab) with a dose and a standard administration rhythm (according to the AMM).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICM Val d'Aurelle | Montpellier | Montpellier | 34298 | France | ||
| Institut du Cancer de Montpellier - Val d'Aurelle |
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From baseline to the end of treatment |
| 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 | 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 | Approximately 8 weeks |
| Proportion of patients with a BRAF mutation under anti-EGFR therapy | From baseline to the end of treatment | Approximately 8 weeks |
| Progression-free survival | From baseline to the database cutoff | Approximately 36 months |
| Global survival | From baseline to the database cutoff | Approximately 36 months |
| Evaluation of the following criterion: total concentration of circulating DNA | From baseline to the end of treatment | Approximately 8 weeks |
| Evaluation of the following criterion: integrity index | From baseline to the end of treatment | Approximately 8 weeks |
| Evaluation of the following criterion: concentration of mutated alleles | From baseline to the end of treatment | Approximately 8 weeks |
| Evaluation of the following criterion: frequency of mutated alleles | From baseline to the end of treatment | Approximately 8 weeks |
| Montpellier |
| 34298 |
| France |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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