Insights on Dissemination of Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Measurement and quantification of CTC and ctDNA
研究概览
简要总结
In patients with resectable NSCLC treated with surgery alone or with surgery as part of a multimodal treatment; CTC, ctDNA, STAS, and lymph node micrometastasis levels will be evaluated to see if they are associated with recurrence patterns and long-term outcomes.
详细描述
In patients with resectable NSCLC treated with surgery alone or with surgery as part of a multimodal treatment, CTC, ctDNA, STAS, and lymph node micrometastasis levels will be evaluated to see if they are associated with recurrence patterns and long-term outcomes.
To achieve this objective, the presence and count of CTC and ctDNA will be analyzed from peripheral venous blood samples collected at three time points (before and after surgery and during follow-up). In addition, the following aspects will be evaluated as secondary objectives:
- Evaluate the consistency of spatial transcriptomics between tumor cells located in the primary lung tumor and those present in STAS and/or lymph node metastases, as well as differences in the molecular profile between primary lung tumor cells and circulating tumor cells.
- Quantify the impact of intraoperative variables on the release of CTCs and ctDNA into the bloodstream.
The main intraoperative variables are:
- The sequence of resection of hilar structures (e.g., vein first vs. artery first).
- Lung manipulation techniques (open surgery, VATS RATS).
- The extent of resection (segmentectomy, lobectomy, pneumonectomy). CTCs will be analyzed using the current gold standard CTCs will be analyzed using the current gold standard platform CTC (CellSearch system, Menarini Silicon Biosystems, Italy), while ctDNA will be evaluated using Next Generation Sequencing (NGS) technology (ILLUMINA platform).
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;
- •Preoperative diagnosis of resectable stage cIA-cIIIA NSCLC (adenocarcinoma or squamous cell carcinoma);
- •Patients deemed fit for surgical or multimodal treatment;
- •Informed consent obtained;
- •Treatment, including multimodal treatment, involving surgery.
排除标准
- •Histology other than adenocarcinoma or squamous cell carcinoma;
- •Other neoplastic diseases concurrent with or undergoing treatment or treated with systemic therapies in the previous three years;
- •Age <18 years;
- •No need for surgery.
结局指标
主要结局
Measurement and quantification of CTC and ctDNA
时间窗: From enrollment to the end of study at 36 months
* CTC (Circulating Tumor Cells) using CellSearch® (FDA-cleared) number cells per 7.5 mL of whole blood * ctDNA (Circulating Tumor DNA) using NGS (Illumina platform) - Variant Allele Frequency VAF (%)
次要结局
未报告次要终点