Non-Small Cell Lung CancerLiquid biopsyNCT07432308
Liquid Biopsy Genotyping Using Oncomine Precision Assay GX in Advanced NSCLC
A study testing Oncomine Precision Assay GX ctDNA Testing in people with Non-Small Cell Lung Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Oncomine Precision Assay GX ctDNA Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Feb 2024to 19 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Oncomine Precision Assay GX ctDNA Testing
- Keywords
- Circulating Tumor DNA, ctDNA, Molecular Diagnostics, Precision Oncology
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncomine Precision Assay GX ctDNA TestingDiagnostic test
Also called Liquid biopsy, Circulating tumor DNA (ctDNA) genotyping, Oncomine Precision Assay GX
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Oncomine Precision Assay GX ctDNA Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From baseline blood sampling through study completion (up to 19 months)
Secondary outcomes (2)
Concordance Rate Between ctDNA Genotyping and Tumor Tissue Molecular Testing
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.
Measured: From baseline through study completion (up to 19 months)
Detection Rate of Clinically Relevant Genetic Alterations in ctDNA
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.
Measured: From baseline blood sampling through study completion (up to 19 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Feb 2024
- Primary completion31 Aug 2024
- Study completion19 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432308
- Sponsor's protocol ID
- OI_Liquid biopsy_2024
- Other IDs
- ERIDNPVO-0010/2024
- Acronym
- Liquid biopsy
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Oncomine Precision Assay GX Method for Genotyping Circulating Tumor DNA in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT07432308
- Acronym / sponsor ID
- Liquid biopsy / OI_Liquid biopsy_2024
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Circulating Tumor DNA, ctDNA, Molecular Diagnostics, Precision Oncology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 19 Aug 2025 (actual)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Oncomine Precision Assay GX ctDNA Testing | Experimental | Diagnostic Test: Oncomine Precision Assay GX ctDNA TestingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oncomine Precision Assay GX ctDNA TestingAlso: Liquid biopsy, Circulating tumor DNA (ctDNA) genotyping, Oncomine Precision Assay GXPeripheral 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. | Diagnostic test | Oncomine Precision Assay GX ctDNA Testing |
Primary outcome
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).
2 secondary outcomes
Concordance Rate Between ctDNA Genotyping and Tumor Tissue Molecular Testing
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Non-Small Cell Lung Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2/3
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
RecruitingPhase 3
A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)
Non-small Cell Lung Cancer
Recruiting
Understanding the Feasibility of a Co-designed Pre-radiotherapy Exercise Programme - A Single-arm Study
Lung Cancer
RecruitingPhase 2
Adjuvant ctDNA-Adapted Personalized Treatment in Early Stage NSCLC (ADAPT-E)
Non-small Cell Lung Cancer, Non-small Cell Lung Cancer Stage I
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oncomine Precision Assay GX ctDNA Testing in people with Non-Small Cell Lung Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Rate of ctDNA Genotyping Using Oncomine Precision Assay GX (time frame: From baseline blood sampling through study completion (up to 19 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.