The present study will investigate the feasibility and clinical value of using circulating tumor DNA as selection for anti-epidermal growth factor receptor treatment for metastatic colorectal cancer.
The primary aim of this prospective study is to investigate if cfDNA in plasma is feasible and reliable for selection of mCRC patients who will benefit of anti-EGFR monoclonal antibody therapy Secondary, to analyze developments in mutational status as reflected by cfDNA in plasma during therapy and at time of progression
Study Type
OBSERVATIONAL
Enrollment
49
Clinical utility of ctDNA analysis for treatment decision
Aarhus University Hospital
Aarhus, Denmark
Feasibility of ctDNA analysis for RAS mutation analysis
Feasibility measures Identification of wildtype or mutated status and results delivered to clinicians * Initial clinical test results i.e. ctDNA mutations or wildtype status within 7 days * Detailed mutation type characterization is provided retrospectively. Failure parameters * Quality of samples; PB \> 5%, CPP1 major loss \< 10% * Transportation \> 3 week days * Analysis \> 3 working days * Total results delivered \> 7 days.
Time frame: maximum 7 days
Retrospective concordance analysis
Retrospective comparison of tumor mutation and plasma mutation analysis at baseline
Time frame: By end of study, expected after 3 years
Disease control rate
Rate of disease control
Time frame: 1 year
OS
Overall survival rate
Time frame: 3 years
Resistance mutations
Rate of Ectoderm mutations at time of progression
Time frame: At time of progression, data analysis expected after 3 years
Lead time
Calcualted lead time between radiologically detected progression and molecular biologically detected ( by Ectoderm and other resistance mutations) in the ctDNA.
Time frame: At time of progression, data analysis expected after 3 years
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