Liquid Biopsy Genotyping Using Oncomine Precision Assay GX in Advanced NSCLC (Liquid biopsy)

March 4, 2026 updated by: Institute of Oncology Ljubljana

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Institute of Oncology Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oncomine Precision Assay GX ctDNA Testing
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
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.
Other Names:
  • Liquid biopsy
  • Circulating tumor DNA (ctDNA) genotyping
  • Oncomine Precision Assay GX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility Rate of ctDNA Genotyping Using Oncomine Precision Assay GX
Time Frame: 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).
From baseline blood sampling through study completion (up to 19 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance Rate Between ctDNA Genotyping and Tumor Tissue Molecular Testing
Time Frame: 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.
From baseline through study completion (up to 19 months)
Detection Rate of Clinically Relevant Genetic Alterations in ctDNA
Time Frame: 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.
From baseline blood sampling through study completion (up to 19 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Oncology Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Actual)

August 31, 2024

Study Completion (Actual)

August 19, 2025

Study Registration Dates

First Submitted

February 18, 2026

First Submitted That Met QC Criteria

February 18, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OI_Liquid biopsy_2024
  • ERIDNPVO-0010/2024 (Other Identifier: Institute of Oncology Ljubljana)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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