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).
1 other identifier
observational
5,000
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 2, 2020
CompletedFirst Submitted
Initial submission to the registry
April 20, 2022
CompletedFirst Posted
Study publicly available on registry
May 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2022
CompletedNovember 4, 2024
November 1, 2024
2.1 years
April 20, 2022
November 1, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
patients with NSCLC with KRAS G12C mutation positive tumours.
You may qualify if:
- All patients who provided consent (by signing and dating the ICF for Protocol No.
- ), may be included in the Clinical Performance Study.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- QIAGEN Gaithersburg, Inclead
- Amgencollaborator
Study Sites (1)
QIAGEN Gaithersburg, Inc
Manchester, M130BH, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2022
First Posted
May 4, 2022
Study Start
April 2, 2020
Primary Completion
May 26, 2022
Study Completion
May 26, 2022
Last Updated
November 4, 2024
Record last verified: 2024-11