Status:
COMPLETED
Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit
Lead Sponsor:
QIAGEN Gaithersburg, Inc
Collaborating Sponsors:
Amgen
Conditions:
Non-Small Cell Lung Cancer
Colorectal Cancer
Eligibility:
All Genders
Phase:
NA
Brief Summary
An interventional, prospective clinical performance study protocol, for the testing of DNA extracted from tumor tissue biopsy samples, using the therascreen® KRAS RGQ PCR Kit, from patients with Non-S...
Detailed Description
This is an interventional, prospective clinical performance study protocol, for the testing of DNA extracted from tumor tissue biopsy samples (either core needle (NSCLC only) or excisional biopsies), ...
Eligibility Criteria
Inclusion
- All patients who provided consent (by signing and dating the Consent Form for Amgen Protocol No. 20170543), may be included in the device study.
Exclusion
- Patients whose tumor tissue biopsy samples are not Clinical Trial Assay evaluable will be excluded from the study. Additionally, patients with samples identified for the study which have insufficient testing material will also be excluded, as will specimens which have undergone decalcification.
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2020
Estimated Enrollment :
309 Patients enrolled
Trial Details
Trial ID
NCT05348187
Start Date
July 1 2019
End Date
November 23 2020
Last Update
November 4 2024
Active Locations (1)
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1
QIAGEN Gaithersburg, Inc
Manchester, United Kingdom, M130BH