Impatto Della Biopsia Liquida Sul Percorso Terapeutico Del Tumore al Polmone: Anticipare la Caratterizzazione Molecolare Dei Pazienti Con Adenocarcinoma Del Polmone in Stadio Avanzato Integrando la Biopsia Liquida Nella Fase Iniziale Del Percorso Diagnostico-terapeutico
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Feasibility of establishing a structured plasma-first molecular profiling dataset
研究概览
简要总结
This multicenter pilot observational study aims to assess the feasibility of introducing liquid biopsy at an early stage of the diagnostic pathway for patients with suspected advanced non-small cell lung cancer (NSCLC).
Liquid biopsy is a minimally invasive blood test that can detect tumor-related genetic alterations in circulating nucleic acids. The study will evaluate whether this approach can provide molecular information more rapidly than standard tissue-based testing and how closely the results obtained from blood samples match those obtained from tumor tissue.
Approximately 70 adult patients with radiological evidence of locally advanced or metastatic lung cancer will be enrolled. Participants will undergo a blood draw for liquid biopsy and will continue to follow the standard diagnostic pathway, including tissue biopsy or cytological sampling when indicated.
The results generated within the study are intended for research purposes and will not replace standard diagnostic procedures or independently determine treatment decisions. The findings will be used to identify practical and methodological issues and to support the design of future clinical studies on the plasma-first approach.
详细描述
Molecular characterization is an essential step in the management of advanced non-small cell lung cancer (NSCLC), as the identification of actionable genomic alterations may guide the selection of targeted therapies. However, tissue-based molecular testing may be delayed or limited by insufficient or poor-quality biological material.
Liquid biopsy allows the analysis of circulating tumor-derived nucleic acids from a peripheral blood sample and may provide molecular information earlier in the diagnostic pathway. The plasma-first approach consists of performing liquid biopsy at an early stage, while the patient continues the standard diagnostic process.
This is a multicenter, prospective, non-pharmacological pilot observational study involving adult patients with radiological suspicion of locally advanced NSCLC not suitable for locoregional treatment or metastatic NSCLC. Eligible patients must have a tissue biopsy or cytological sampling planned but not yet performed, or already performed without an available histopathological diagnosis of NSCLC at the time of enrollment.
Each participant will undergo a peripheral blood draw for liquid biopsy within one week of the first clinical assessment. Plasma-derived circulating nucleic acids will be analyzed using next-generation sequencing (NGS). Participants will then continue the standard diagnostic pathway of the enrolling center, including tissue biopsy or cytological sampling, histopathological diagnosis, PD-L1 assessment, and standard tissue-based molecular profiling.
The study will assess the feasibility of the plasma-first approach and will generate a structured dataset to support the design of future prospective studies. Secondary objectives include evaluating:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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.
- •Radiological suspicion of locally advanced lung cancer not amenable to locoregional treatment or metastatic lung cancer (stage III-IV).
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-
- •Tissue biopsy and/or cytological sampling planned but not yet performed, or already performed without an available histopathological diagnosis of non-small cell lung cancer (NSCLC).
- •Written informed consent for study participation and personal data processing obtained before any study-specific procedure.
排除标准
- •Previous or current history of non-small cell lung cancer (NSCLC).
- •Histopathological diagnosis of NSCLC already available following tissue biopsy.
- •Eligibility for surgical removal of tumor tissue.
- •Ongoing or previous systemic oncological treatment for lung cancer.
研究组 & 干预措施
Prospective Plasma-First NSCLC Cohort
Adult patients with radiological suspicion of locally advanced non-small cell lung cancer (NSCLC) not suitable for locoregional treatment, or metastatic NSCLC, will be enrolled before completion of the standard diagnostic pathway.
Participants will undergo a peripheral blood draw for liquid biopsy within one week of the first clinical assessment. Plasma-derived circulating nucleic acids will be analyzed using next-generation sequencing (NGS) to evaluate molecular alterations, turnaround time, concordance with tissue-based profiling, and tumor fraction.
All participants will continue the standard diagnostic pathway of the enrolling center, including tissue biopsy or cytological sampling, histopathological diagnosis, PD-L1 assessment, and tissue-based molecular testing. No investigational treatment is assigned, and study procedures will not independently determine treatment decisions.
干预措施: Plasma-based liquid biopsy (Diagnostic Test)
结局指标
主要结局
Feasibility of establishing a structured plasma-first molecular profiling dataset
时间窗: Up to 18 months
Proportion of enrolled participants with a complete structured dataset including liquid biopsy results, tissue-based diagnostic and molecular profiling results, and relevant clinical data required for the feasibility assessment of the plasma-first approach.
次要结局
- Turnaround time for plasma-based molecular profiling(Up to 7 days from blood collection)
- Proportion of participants with informative liquid biopsy results(Up to 30 days from enrollment)
- Concordance between plasma-based and tissue-based molecular profiling(Up to 30 days from enrollment)
- Tumor fraction in plasma samples(Up to 30 days from blood collection)
- Analytical performance of two NGS-based plasma profiling approaches(Up to 18 months)