Evaluation of the Oncomine Precision Assay GX Method for Genotyping Circulating Tumor DNA in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Feasibility Rate of ctDNA Genotyping Using Oncomine Precision Assay GX
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Oncomine Precision Assay GX ctDNA Testing (Diagnostic Test)
结局指标
主要结局
Feasibility Rate of ctDNA Genotyping Using Oncomine Precision Assay GX
时间窗: 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).
次要结局
- Detection Rate of Clinically Relevant Genetic Alterations in ctDNA(From baseline blood sampling through study completion (up to 19 months))
- Concordance Rate Between ctDNA Genotyping and Tumor Tissue Molecular Testing(From baseline through study completion (up to 19 months))