Interventional IVD Study Testing DNA From Tumor Tissue Biopsies From mCRC Patients to Determine KRAS G12C Mutation Status for the Inclusion in the Amgen Clinical Trial, 20210081 for the Clinical Performance of Therascreen4 KRAS RGQ PCR Kit

What this Trial Is About

Researchers are evaluating the clinical performance of the therascreen4 KRAS RGQ PCR Kit as a screening tool to identify patients with metastatic colorectal cancer (mCRC) who have the KRAS G12C mutation. This device study is conducted alongside Amgen's Phase 3 clinical trial (20210081), which compares treatments including sotorasib, panitumumab, and FOLFIRI against FOLFIRI with or without bevacizumab in treatment-naefve patients with mCRC. Approximately 450 patients from multiple countries will be enrolled based on mutation status and other trial criteria. The therascreen4 KRAS RGQ PCR Kit is a real-time qualitative PCR assay that uses DNA extracted from formalin-fixed, paraffin-embedded colorectal cancer tissue samples. It operates with the QIAamp DSP DNA FFPE Kit for sample preparation and the Rotor-Gene Q MDx instrument for PCR analysis and result reporting. The kit includes controls to verify test validity. This device helps determine mutation status during the screening period of the clinical trial. Participants will provide tumor tissue biopsies for DNA testing with the therascreen kit. Researchers will monitor the detection of KRAS G12C mutation status and evaluate progression-free survival over a period of six years, ending in 2030. The study aims to establish the kit's performance as a companion diagnostic to identify patients who may benefit from sotorasib treatment. Safety monitoring and long-term follow-up will be conducted throughout the trial duration.

DHF-20-1839-2: Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit