Actively Recruiting
DHF-20-1839-2: Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit
Led by QIAGEN Gaithersburg, Inc · Updated on 2025-08-15
600
Participants Needed
1
Research Sites
357 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
DHF-20-1839-2: Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- There is no separate inclusion and exclusion criteria for the performance study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
QIAGEN Gaithersburg, Inc
Manchester, Manchester, United Kingdom, M130BH
Actively Recruiting
Research Team
S
Sarah Johnson, Dr.
CONTACT
P
Parul Choudhary
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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