Testing of DNA Extracted From Tumor Tissue Biopsy Samples Using Therascreen KRAS RGQ PCR Kit
NCT ID: NCT05360225
Last Updated: 2024-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
5000 participants
OBSERVATIONAL
2020-04-02
2022-05-26
Brief Summary
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Detailed Description
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Up to 7000 patient tissue samples (from approximately 5000 patients at 500 clinical trial sites), obtained in the Clinical Study (Protocol No. 20190294), will be tested using the KRAS kit. The testing will be performed at the investigational device clinical testing sites, Q2 Solutions Laboratories in the four geographical locations: USA, Singapore, UK and China
Conditions
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Study Design
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CASE_ONLY
OTHER
Study Groups
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Clinical Performance Study Protocol for therascreen® KRAS RGQ PCR Kit
The KRAS System (extraction kit, analytical kit, instrument and software) will be used to test FFPE biopsy (resected and core needle biopsy \[CNB\]/fine needle aspiration \[FNA\]) tumour tissue from NSCLC patients to establish KRAS G12C mutation status. This will be determined using the investigational device at Q2 Solutions Laboratories.
therascreen® KRAS RGQ PCR Kit
The KRAS Kit is a real-time qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of somatic G12C mutations in the human KRAS oncogene using DNA extracted from formalin fixed paraffin-embedded (FFPE) Non-small Cell Lung Cancer (NSCLC) tissue.
Interventions
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therascreen® KRAS RGQ PCR Kit
The KRAS Kit is a real-time qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of somatic G12C mutations in the human KRAS oncogene using DNA extracted from formalin fixed paraffin-embedded (FFPE) Non-small Cell Lung Cancer (NSCLC) tissue.
Eligibility Criteria
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Inclusion Criteria
20190294), may be included in the Clinical Performance Study.
Exclusion Criteria
* Patients with samples identified for the study which have insufficient testing material
* Specimens which have undergone decalcification.
ALL
No
Sponsors
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Amgen
INDUSTRY
QIAGEN Gaithersburg, Inc
INDUSTRY
Responsible Party
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Locations
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QIAGEN Gaithersburg, Inc
Manchester, , United Kingdom
Countries
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Other Identifiers
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QMAN-18-0181-1 004
Identifier Type: -
Identifier Source: org_study_id
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