OPTImal PALliative Anti-epidermal Growth Factor Receptor Treatment in Metastatic Colorectal Cancer -

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

49 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-01

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Colorectal Cancer Metastatic Circulating Tumor DNA KRAS Gene Mutation NRAS Gene Mutation BRAF Gene Mutation Epidermal Growth Factor Receptor Inhibitor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Plasma circulating DNA analysis

Intervention Type OTHER

Clinical utility of ctDNA analysis for treatment decision

Interventions

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Plasma circulating DNA analysis

Clinical utility of ctDNA analysis for treatment decision

Intervention Type OTHER

Eligibility Criteria

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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