Testing of DNA Extracted From Tumor Tissue Biopsy Samples Using Therascreen KRAS RGQ PCR Kit

Study Overview
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Brief Summary
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A Non-interventional Biomarker Study for the testing of DNA extracted from tumour tissue biopsy samples, using the therascreen® KRAS RGQ PCR Kit, from patients with Non-Small Cell Lung Cancer, screened in Clinical Study (Protocol No. 20190294).

Detailed Description
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This is a non-interventional, biomarker screening clinical performance study protocol, for the testing of DNA extracted from tumour tissue biopsy samples (resected and core needle biopsy [CNB]/fine needle aspiration [FNA] tumour tissue) obtained from patients with Non-Small Cell Lung Cancer (NSCLC), using the KRAS Kit. A formal hypothesis will not be tested in this study. 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

Official Title
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Non-interventional Biomarker Study Testing DNA Extracted From Tumour Tissue Biopsy Samples, Using the Therascreen® KRAS RGQ PCR Kit, From Patients With Non-Small Cell Lung Cancer, Screened in Clinical Study (Protocol No. 20190294).

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Diagnostic Test: therascreen® KRAS RGQ PCR Kit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients who provided consent (by signing and dating the ICF for Protocol No. 20190294), may be included in the Clinical Performance Study. Exclusion Criteria: Patients whose tumour tissue biopsy samples that are not Clinical Study Assay evaluable Patients with samples identified for the study which have insufficient testing material Specimens which have undergone decalcification.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clinical Performance Study Protocol for therascreen® KRAS RGQ PCR Kit<br>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. | Diagnostic Test: therascreen® KRAS RGQ PCR Kit<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients with NSCLC with KRAS G12C mutation positive tumours. | To utilize a Clinical Trial Assay, the KRAS Kit, as a screening test in Phase 3 of Clinical Study (Protocol No. 20190294), in order to identify patients with NSCLC with KRAS G12C mutation positive tumours. | 5 business days |