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

Qiagen

Status: Completed

Conditions: Non Small Cell Lung Cancer

Treatments: Diagnostic Test: therascreen® KRAS RGQ PCR Kit

Study type: Observational

Funder types: Industry

Identifiers

NCT05360225

QMAN-18-0181-1 004

Details and patient eligibility

About

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).

Full description

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

Enrollment: 5,000 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

5,000 participants in 1 patient group

Clinical Performance Study Protocol for therascreen® KRAS RGQ PCR Kit

Description:

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.

Treatment:

Diagnostic Test: therascreen® KRAS RGQ PCR Kit