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

Sponsor

QIAGEN Gaithersburg, Inc (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05360225

Collaborator

Amgen (Industry)

5,000

Enrollment

Location

25.9

Anticipated Duration (Months)

193.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Diagnostic Test: therascreen® KRAS RGQ PCR Kit

Detailed 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

Study Design

Study Type:

Observational

Anticipated Enrollment :

5000 participants

Observational Model:

Case-Only

Time Perspective:

Other

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).

Actual Study Start Date :

Apr 2, 2020

Actual Primary Completion Date :

May 20, 2021

Anticipated Study Completion Date :

May 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	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.

Arm

Intervention/Treatment

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.

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.

Outcome Measures

Primary Outcome Measures

patients with NSCLC with KRAS G12C mutation positive tumours. [5 business days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	QIAGEN Gaithersburg, Inc	Manchester		United Kingdom	M130BH

Sponsors and Collaborators

QIAGEN Gaithersburg, Inc
Amgen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

QIAGEN Gaithersburg, Inc

ClinicalTrials.gov Identifier:

NCT05360225

Other Study ID Numbers:

QMAN-18-0181-1 004

First Posted:

May 4, 2022

Last Update Posted:

May 4, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of May 4, 2022