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

Study Overview
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Brief Summary
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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).

Official Title
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RAS Mutation Testing in the Circulating Blood of Patients With Metastatic Colorectal Cancer: Concordance With the Standard Testing Method From Tumor Tissue and Review of Associated Timelines and Costs

Conditions
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Colorectal Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 | 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 | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RAS mutation, DNA, Colorectal Cancer