Circulating Metabolites and Tumor-derived Extravesicular Proteins in Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Identification and validation of protein biomarkers
研究概览
简要总结
The aim of this study is to gather insight into tumor-derived circulating extracellular vesicles-proteins in patients with newly diagnosed small cell lung cancer.
详细描述
The study will include 50 patients with newly diagnosed SCLC, referred to systemic antineoplastic treatment at the Dept. of Oncology, Aalborg University Hospital and blood samples from 50 healthy blood donors.
The blood samples from SCLC patients will be collected before chemotherapy with Carboplatin and Etoposide and after 2 cycles of chemotherapy.
Imaging will be performed at the Dept. of Radiology, Aalborg University Hospital before chemotherapy and after 3 cycles of the treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Written and signed informed consent
- •Histopathologically and/or cytologically newly-diagnosed SCLC
- •Measurable disease on CT scans
- •Eligibility to receive standard chemotherapy consisting of carboplatin and etoposide
排除标准
- •Active biopsy-verified second malignancy other than non-melanoma skin cancer or cervical carcinoma in situ
- •Prior treatment for any malignant diseases other than non-melanoma skin cancer and cervical carcinoma in situ
- •Concomitant anticoagulation treatment (acetylsalicylic acid and clopidogrel are allowed)
- •Treatment with any other investigational agent
结局指标
主要结局
Identification and validation of protein biomarkers
时间窗: 3 years
For identification and validation of protein biomarkers both untargeted and targeted proteomics will be performed, including a discovery-based bottom-up mass spectrometry approach and label-free Quantification Nano Liquid Chromatography Tandem Mass Spectrometry (LFQ nLC-MS/MS), enzyme-linked immunosorbent assay (ELISA)-based proteomics, and Western Blot analyses.
次要结局
未报告次要终点
研究者
Weronika Maria Szejniuk
MD, PhD
Aalborg University Hospital