DHF-20-1839-2: Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit
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 Therascreen® KRAS RGQ PCR Kit
QIAGEN Gaithersburg, Inc
600 participants
Dec 22, 2023
INTERVENTIONAL
Conditions
Summary
To utilize the therascreen KRAS RGQ PCR Kit, as a screening test in Amgen's Phase 3 Clinical Study Protocol 20210081, in order to identify patients with mCRC KRAS G12C mutation positive tumors to be enrolled in the drug clinical trial. Results of the Phase 3 Amgen Study 20210081 will serve as the basis for establishing the clinical performance of the therascreen® KRAS RGQ PCR Kit as a companion diagnostic (CDx) for the identification of patients with metastatic colorectal cancer, who may benefit from treatment with sotorasib.
Eligibility
Inclusion Criteria1
- Subjects who consent to participate in the eligibility screen for Protocol 20210081 will have their tumor tissue tested for the presence of KRAS G12C mutation under the proposed performance study.
Interventions
The investigational device, therascreen® KRAS RGQ PCR Kit, will be used to determine the KRAS G12C mutation status of patients during the screening period of Amgen's clinical trial (20210081)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06645236