Clinical trial · Observational
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).
NCT05360225CI-TRIAL-00082171completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| therascreen® KRAS RGQ PCR Kit | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Diagnostic Test: therascreen® KRAS RGQ PCR Kit
Primary outcomes (1)
- measure
- patients with NSCLC with KRAS G12C mutation positive tumours.
- timeFrame
- 5 business days
- description
- 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
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.