Intplex test
DeviceBlood sample at each tumor assessment
NCT Number: NCT03908788
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
ICM Val d'Aurelle, Montpellier, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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).
Blood sample at each tumor assessment
Time frame: Approximately 8 weeks
From baseline to the end of treatment
Time frame: Approximately 8 weeks
From baseline to the end of treatment
Time frame: Approximately 8 weeks
From baseline to the end of treatment
Time frame: Approximately 8 weeks
From baseline to the end of treatment
Time frame: Approximately 8 weeks
From baseline to the end of treatment
Time frame: Approximately 8 weeks
From baseline to the end of treatment
Time frame: Approximately 36 months
From baseline to the database cutoff
Time frame: Approximately 36 months
From baseline to the database cutoff
Time frame: Approximately 8 weeks
From baseline to the end of treatment
Time frame: Approximately 8 weeks
From baseline to the end of treatment
Time frame: Approximately 8 weeks
From baseline to the end of treatment
Time frame: Approximately 8 weeks
From baseline to the end of treatment
Institut du Cancer de Montpellier - Val d'Aurelle
Other
Detection of the Emergence of RAS (Rat Sarcoma Viral Oncogene Homolog) Mutations in Circulating DNA (Deoxyribonucleic Acid) in Patients With Metastatic Colorectal Cancer During Treatment With Anti-EGFR (Epidermal Growth Factor Receptor) Therapy
Acronym: EmutRAS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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