Clinical trial · Observational
OPTImal PALliative Anti-epidermal Growth Factor Receptor Treatment in Metastatic Colorectal Cancer -
OPTImal PALliative Anti-epidermal Growth Factor Receptor Treatment in Metastatic Colorectal Cancer - Feasibility Study Investigating Circulating Tumor DNA for Treatment Decisions
NCT03750175CI-TRIAL-00063649OPTIPAL-IIcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRAF Gene Mutation | — | UNRESOLVED | — |
| Circulating Tumor DNA | — | UNRESOLVED | — |
| Colorectal Cancer Metastatic | — | UNRESOLVED | — |
| Epidermal Growth Factor Receptor Inhibitor | — | UNRESOLVED | — |
| KRAS Gene Mutation | — | UNRESOLVED | — |
| NRAS Gene Mutation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Plasma circulating DNA analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Colorectal cancer patients
- description
- 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
- interventionNames
- Other: Plasma circulating DNA analysis
Primary outcomes (1)
- measure
- Feasibility of ctDNA analysis for RAS mutation analysis
- timeFrame
- maximum 7 days
- description
- 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 outcomes (5)
- measure
- Retrospective concordance analysis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDCallesen 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. PMID 35154704