Liquid Biopsy Genotyping Using Oncomine Precision Assay GX in Advanced NSCLC

NCT07432308 | Completed

• 2 other identifiers: OI_Liquid biopsy_2024ERIDNPVO-0010/2024
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

Circulating Tumor DNA; ctDNA; Molecular Diagnostics; Precision Oncology

Outcome Measures

Primary Outcomes (1)

• Feasibility Rate of ctDNA Genotyping Using Oncomine Precision Assay GX

  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).

  From baseline blood sampling through study completion (up to 19 months)

Secondary Outcomes (2)

• Concordance Rate Between ctDNA Genotyping and Tumor Tissue Molecular Testing

  From baseline through study completion (up to 19 months)

• Detection Rate of Clinically Relevant Genetic Alterations in ctDNA

  From baseline blood sampling through study completion (up to 19 months)

Study Arms (1)

Oncomine Precision Assay GX ctDNA Testing

EXPERIMENTAL

Participants with advanced non-small cell lung cancer undergo peripheral blood sampling for circulating tumor DNA (ctDNA) analysis using the Oncomine Precision Assay GX method. The assay is evaluated for feasibility and diagnostic performance in routine clinical practice and compared with standard molecular testing results.

Diagnostic Test: Oncomine Precision Assay GX ctDNA Testing

Interventions

Oncomine Precision Assay GX ctDNA Testing DIAGNOSTIC_TEST

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.

Also known as: Liquid biopsy, Circulating tumor DNA (ctDNA) genotyping, Oncomine Precision Assay GX

Oncomine Precision Assay GX ctDNA Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Liquid Biopsy; Genotype

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques; Genetic Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 25, 2026
• Study Start: February 1, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 19, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)