BRAF Gene Mutation, Circulating Tumor DNA, Colorectal Cancer Metastatic, Epidermal Growth Factor Receptor Inhibitor, KRAS Gene Mutation, NRAS Gene Mutation
Conditions
Brief summary
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.
Detailed description
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
Interventions
OTHERPlasma circulating DNA analysis
Clinical utility of ctDNA analysis for treatment decision
Sponsors
Karen-Lise Garm Spindler
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histopathologically verified metastatic colorectal cancer * Indication for systemic palliative treatment with standard Anti-EGFR monoclonal antibodies * Fit for therapy with EGFR inhibition * Consent to treatment and sampling * Measureable disease according to RECIST v 1.1 * Age ≥ 18
Exclusion criteria
* PS \> 2 * Significant other cancer disease within 5 years of inclusion * Conditions precluding sampling during therapy and treatment breaks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of ctDNA analysis for RAS mutation analysis | maximum 7 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retrospective concordance analysis | By end of study, expected after 3 years | Retrospective comparison of tumor mutation and plasma mutation analysis at baseline |
| Disease control rate | 1 year | Rate of disease control |
| OS | 3 years | Overall survival rate |
| Resistance mutations | At time of progression, data analysis expected after 3 years | Rate of Ectoderm mutations at time of progression |
| Lead time | At time of progression, data analysis expected after 3 years | Calcualted lead time between radiologically detected progression and molecular biologically detected ( by Ectoderm and other resistance mutations) in the ctDNA. |
Countries
Denmark
Outcome results
None listed