Status:
COMPLETED
Clinical Study Testing DNA Extracted From Tumour Tissue Biopsy Samples, Using the Therascreen® KRAS RGQ PCR Kit
Lead Sponsor:
QIAGEN Gaithersburg, Inc
Collaborating Sponsors:
Amgen
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
Phase:
NA
Brief Summary
An interventional, prospective study. It is estimated that up to 800 patient tissue samples (from approximately 650 patients enrolled at approximately 300 clinical trial sites), will be obtained as pa...
Detailed Description
This is an interventional, prospective clinical performance study protocol, for the testing of DNA extracted from tumour tissue biopsy samples (resected and core needle biopsy \[CNB\]/fine needle aspi...
Eligibility Criteria
Inclusion
- All patients who provided consent (by signing and dating the ICF for Protocol No. 20190009), may be included in the Clinical Performance Study.
Exclusion
- Patients whose tumour tissue biopsy samples are not Clinical Study Assay evaluable will be asked to provide further tumour tissue biopsy samples. Patients with samples identified for the study which have insufficient testing material will have their sample excluded, as will specimens which have undergone decalcification.
Key Trial Info
Start Date :
March 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2021
Estimated Enrollment :
495 Patients enrolled
Trial Details
Trial ID
NCT05347797
Start Date
March 13 2020
End Date
April 22 2021
Last Update
November 4 2024
Active Locations (1)
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1
QIAGEN Gaithersburg, Inc
Manchester, United Kingdom, M130BH