NCT07432308

Liquid Biopsy Genotyping Using Oncomine Precision Assay GX in Advanced NSCLC

Evaluation of the Oncomine Precision Assay GX Method for Genotyping Circulating Tumor DNA in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Institute of Oncology Ljubljana · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This interventional clinical study evaluates the clinical utility and feasibility of the Oncomine Precision Assay GX method for genotyping circulating tumor DNA (ctDNA) in patients with advanced non-small cell lung cancer (NSCLC). Participants with advanced NSCLC undergo peripheral blood sampling as part of the study intervention. Circulating tumor DNA is analyzed using the Oncomine Precision Assay GX platform. Molecular findings obtained from liquid biopsy are compared with available standard diagnostic results from tumor tissue or other clinically indicated molecular testing methods. The aim of the study is to evaluate the feasibility, diagnostic performance, and clinical applicability of ctDNA genotyping using the Oncomine Precision Assay GX method in a real-world clinical setting and to assess its potential role in routine molecular diagnostics of advanced NSCLC.

Detailed description

This prospective interventional clinical study evaluates the performance and clinical applicability of the Oncomine Precision Assay GX method for genotyping circulating tumor DNA (ctDNA) in patients with advanced non-small cell lung cancer (NSCLC). Liquid biopsy represents an important molecular diagnostic approach in lung cancer, particularly when tumor tissue is unavailable, insufficient, or difficult to obtain. The study aims to validate the Oncomine Precision Assay GX platform for potential routine clinical implementation at the Institute of Oncology Ljubljana. Participants with advanced NSCLC undergo peripheral blood collection for ctDNA analysis. Plasma samples are processed and analyzed using the Oncomine Precision Assay GX workflow. Molecular alterations identified in ctDNA are compared with results obtained from standard molecular diagnostics performed on tumor tissue or other clinically indicated testing methods. The study evaluates feasibility, concordance with tissue-based molecular testing, detection rate of clinically relevant genetic alterations, and practical aspects of implementing ctDNA testing in a real clinical environment. The results may support broader use of liquid biopsy approaches in personalized treatment decision-making for patients with advanced NSCLC.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Oncomine Precision Assay GX ctDNA Testing	Peripheral blood samples are collected for circulating tumor DNA (ctDNA) extraction and analysis using the Oncomine Precision Assay GX workflow. The assay is used for molecular genotyping of ctDNA in patients with advanced non-small cell lung cancer, with the purpose of evaluating its performance and feasibility for implementation in routine clinical practice.

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-08-31
• Completion: 2025-08-19
• First posted: 2026-02-25
• Last updated: 2026-03-06

Locations

1 site across 1 country: Slovenia