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Study identifier: NCT06645236 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Metastatic Colorectal Cancer (mCRC)  ·  Sponsor: QIAGEN Gaithersburg, Inc

PhaseNA
Planned participants600
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Sarah Johnson, Dr.  ·  0044 07825866041  ·  sarah.johnson@qiagen.com

Parul Choudhary  ·  Parul.Choudhary@qiagen.com

Always discuss trial participation with your own doctor first.

Locations (1)

QIAGEN Gaithersburg, IncManchester, Manchester, United KingdomRecruiting

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Source record: clinicaltrials.gov/study/NCT06645236