Non-Small Cell Lung Cancer
Conditions
Keywords
Circulating Tumor DNA, ctDNA, Molecular Diagnostics, Precision Oncology
Brief 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.
Interventions
DIAGNOSTIC_TESTOncomine 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.
Sponsors
Institute of Oncology Ljubljana
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Participants with advanced non-small cell lung cancer undergo blood sampling for circulating tumor DNA analysis using the Oncomine Precision Assay GX method. Results are compared with standard clinical molecular testing to evaluate the feasibility and diagnostic performance of the assay.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC) * Planned or ongoing systemic treatment for advanced NSCLC according to standard clinical practice * Availability of blood sample for circulating tumor DNA (ctDNA) analysis * Ability to understand the study procedures and provide written informed consent
Exclusion criteria
* Inability or unwillingness to provide written informed consent * Insufficient blood sample for ctDNA analysis * Any medical condition that, in the investigator's opinion, would interfere with participation or interpretation of results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility Rate of ctDNA Genotyping Using Oncomine Precision Assay GX | From baseline blood sampling through study completion (up to 19 months) | Feasibility is assessed as the proportion of collected blood samples with successful circulating tumor DNA (ctDNA) extraction and successful molecular genotyping using the Oncomine Precision Assay GX method in patients with advanced non-small cell lung cancer (NSCLC). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concordance Rate Between ctDNA Genotyping and Tumor Tissue Molecular Testing | From baseline through study completion (up to 19 months) | Concordance is assessed as the proportion of participants with matching molecular alterations detected by ctDNA analysis using the Oncomine Precision Assay GX method and those detected by tumor tissue molecular profiling. |
| Detection Rate of Clinically Relevant Genetic Alterations in ctDNA | From baseline blood sampling through study completion (up to 19 months) | Detection rate is assessed as the proportion of participants with at least one clinically relevant genetic alteration detected in circulating tumor DNA using the Oncomine Precision Assay GX method. |
Countries
Slovenia
Outcome results
None listed