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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colorectal cancer patients | Clinical utility of ctDNA analysis for treatment decision Use of ctDNA for KRAS, NRAS and BRAF testing prior to potential anti-EGFR monoclonal antibody treatment for metastatic colorectal cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma circulating DNA analysis | Other | Clinical utility of ctDNA analysis for treatment decision |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of ctDNA analysis for RAS mutation analysis | Feasibility measures Identification of wildtype or mutated status and results delivered to clinicians
Failure parameters
| maximum 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Retrospective concordance analysis | Retrospective comparison of tumor mutation and plasma mutation analysis at baseline | By end of study, expected after 3 years |
| Disease control rate | Rate of disease control |
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Inclusion criteria
Exclusion criteria
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Patients with metastatic colorectal cancer and indication for palliative chemotherapy with potential anti-EGFR monoclonal antibody.
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| Name | Affiliation | Role |
|---|---|---|
| Karen-Lise G Spindler | Department of Oncology, AUH, Dk | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35154704 | Derived | Callesen LB, Sorensen BS, Pallisgaard N, Laugesen IG, Boysen AK, Spindler KG. Total cell-free DNA measurement in metastatic colorectal cancer with a fast and easy direct fluorescent assay. Mol Clin Oncol. 2022 Mar;16(3):64. doi: 10.3892/mco.2022.2497. Epub 2022 Jan 17. |
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Plasma samles for circulating DNA analysis
| 1 year |
| OS | Overall survival rate | 3 years |
| Resistance mutations | Rate of Ectoderm mutations at time of progression | 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. | At time of progression, data analysis expected after 3 years |