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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05360225
• Other study ID #: QMAN-18-0181-1 004
• Status: Active, not recruiting
• Start date: April 2, 2020
• Est. completion date: November 14, 2022

Study information

• Verified date: September 2022
• Source: QIAGEN Gaithersburg, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5000
• Est. completion date: November 14, 2022
• Est. primary completion date: May 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United Kingdom	QIAGEN Gaithersburg, Inc	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
QIAGEN Gaithersburg, Inc	Amgen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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