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

NCT03750175 | Completed

• 1 other identifier: KFE1713
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  maximum 7 days

Secondary Outcomes (5)

• Retrospective concordance analysis

  By end of study, expected after 3 years

• Disease control rate

  1 year

• OS

  3 years

• Resistance mutations

  At time of progression, data analysis expected after 3 years

• Lead time

  At time of progression, data analysis expected after 3 years

Study Arms (1)

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

Other: Plasma circulating DNA analysis

Interventions

Plasma circulating DNA analysis OTHER

Clinical utility of ctDNA analysis for treatment decision

Colorectal cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic colorectal cancer and indication for palliative chemotherapy with potential anti-EGFR monoclonal antibody.

You may qualify if:

• 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

You may not qualify if:

• PS \> 2
• Conditions precluding sampling during therapy and treatment breaks.

Sponsors & Collaborators

• Karen-Lise Garm Spindler: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 35154704 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma samles for circulating DNA analysis

Study Officials

• Karen-Lise G Spindler

  Department of Oncology, AUH, Dk

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: November 21, 2018
• Study Start: June 1, 2018
• Primary Completion: June 1, 2022
• Study Completion: December 31, 2022
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)