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

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).

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05360225

Enrollment

5000

Registered

2022-05-04

Start date

2020-04-02

Completion date

2022-05-26

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

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).

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

Interventions

DIAGNOSTIC_TESTtherascreen® 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.

Study design

Observational model

CASE_ONLY

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026