A Clinical Performance Study to Validate the Use of Novel Molecular Diagnostic Assays for the Detection of Cancer Biomarkers in Peripheral Blood and Primary Tumor Tissue of Patients With Recurrent/Metastatic HNSCC, NSCLC or Melanoma.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 6
- 主要终点
- Clinical performance of PD-L1 kit in CTCs of peripheral blood and tumor tissue samples
研究概览
简要总结
Conventional biopsy and surgical tumor resection are invasive procedures that capture only one instance of the progression of the tumor. However, the genome of tumor is not static, but it is constantly altered during treatment.
Liquid biopsy is a non-invasive approach based on the extraction of information through peripheral blood analysis. It makes it possible to characterize the development of a solid tumor in real time, through detailed molecular analysis of circulating genetic material in peripheral blood.
详细描述
Conventional biopsy and surgical tumor resection are invasive procedures that capture only one instance of the progression of the tumor. However, the genome of tumor is not static, but it is constantly altered during treatment.
Liquid biopsy is a non-invasive approach based on the extraction of information through peripheral blood analysis. It makes it possible to characterize the development of a solid tumor in real time, through detailed molecular analysis of circulating genetic material in peripheral blood.
Study procedure:
- Initial Visit (V0-Baseline): For the purposes of the study the following information will be collected: the demographics, medical and social history, the characteristics of the disease (stage, molecular characterization e.t.c) and the treatment regimen that is followed. As part of the visit, 20 mL of peripheral blood will be drawn prior to their treatment according to physician's suggestion as per common clinical practice. Blood samples will be then sent to ACTC laboratory for plasma/CTC isolation, DNA and RNA extraction and subsequent test for biomarkers. Primary tumor tissue samples will be also collected.
- Follow-up visit (V1): All patients will provide a 10 mL peripheral blood sample during their planned visit at the end of a series of immunotherapy cycles as per clinical practice and physician's judgment. More specifically:
For HNSCC/NSCLC: at the end of four (4) treatment cycles with nivolumab (2 months) or at the end of three (3) treatment cycles with pembrolizumab (2 months) or on disease progress (PD) For melanoma: at 6 months after treatment initiation (antiPD-1) Blood samples will be then sent to laboratory for plasma/CTC isolation, DNA and RNA extraction and subsequent test for biomarkers. Clinical response (CR, PR, SD, PD) will be also documented. 3. Follow-up visit (V2): All patients will provide a 10 mL peripheral blood sample on progress of the disease or at the end of the observation period, as diagnosed during their planned visit as per clinical practice and physician's judgment. Blood samples will be then sent to laboratory
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 是
入选标准
- •Male or female aged ≥ 18 years of age.
- •Patients with a diagnosis of
- •recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), who are going to receive PD-1 inhibitor nivolumab OR
- •metastatic Non-Small Cell Lung Cancer (NSCLC), who are going to receive PD-1 inhibitor, e.g. nivolumab, pembrolizumab,OR
- •metastatic melanoma, who are going to receive to receive PD-1 inhibitor, e.g. nivolumab, pembrolizumab.
- •Available tumor tissue sample for immunohistochemical and molecular analysis.
- •Life expectancy ≥ 4 months.
- •Signed informed consent form.
排除标准
- •Male or female younger than 18 years old.
- •History of another malignancy within 3 years or current 2nd primary malignancy.
- •Patients that have not signed the informed consent.
结局指标
主要结局
Clinical performance of PD-L1 kit in CTCs of peripheral blood and tumor tissue samples
时间窗: 12 months
The performance of PD-L1 kit at baseline in CTCs (using IF as reference method) and tumor tissue samples (using IHC as reference method) will be assessed via Sensitivity, Specificity, Positive and Negative Predictive Values, Positive and Negative Likelihood Ratios, Accuracy and Diagnostic Odds Ratio.
次要结局
- To study correlations between PD-L1 expression in serial liquid samples with patients' responsiveness to therapy.(18 months)