RecruitingNot ApplicableNCT06645236

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

Sponsor

QIAGEN Gaithersburg, Inc

Enrollment

600 participants

Start Date

Dec 22, 2023

Study Type

INTERVENTIONAL

Conditions

Metastatic Colorectal Cancer (Mcrc)

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a laboratory performance study testing the Therascreen® KRAS RGQ PCR Kit — a diagnostic test that detects a specific genetic mutation (KRAS G12C) in tumor tissue. This test helps identify which patients may benefit from KRAS-targeted cancer therapies. **You may be eligible if...** - You have already consented to participate in a related clinical trial (Protocol 20210081) and agreed to have your tumor tissue tested for the KRAS G12C mutation under this performance study **You may NOT be eligible if...** - There are no separate specific exclusion criteria for this performance study beyond those of the related trial This is primarily a tissue-testing study rather than a treatment trial. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEtherascreen® KRAS RGQ PCR Kit

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)

QIAGEN Gaithersburg, Inc

Manchester, Manchester, United Kingdom

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NCT06645236

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