Circulating and Imaging Biomarkers to Improve Lung Cancer Management and Early Detection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Obtaining biological samples, and correspondent clinical and imaging data to use, as fresh blood tissues or frozen stored tissues from lung cancer patients and controls obtained from the Division of Thoracic Surgery and LDCT lung-cancer screening program
研究概览
简要总结
Validation of biomolecular markers in the circulation and radiomic features are the focus of this project.The aim is to assess the role of molecular and cellular biomarkers (exosomes antigens, Circulating tumor cells - CTCs, panel of mutations in circulating free DNA) and radiomic signature, as complementary to assist early detection of lung cancer by LDCT.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 55 years old and exposure to smoking more than 30 packs-year; which corresponds to 6-year risk of lung cancer, calculated according to the plco score (≥ 2%).
- •Smoker or former smoker Former smokers must have ceased smoking within the 15 years prior to enrollment in the study.
- •Absence of symptoms of lung cancer such as worsening of cough, hoarseness, hemoptysis and weight loss.
排除标准
- •Previous diagnosis of lung cancer.
- •Positive extrapulmonary cancer history in the last 5 years (excluding in situ tumors or skin epidermoid tumor).
- •Performing a chest CT scan in the last 18 months.
- •Severe lung or extrapulmonary diseases that may preclude or invalidate appropriate therapy in case of diagnosis of malignant pulmonary neoplasia.
结局指标
主要结局
Obtaining biological samples, and correspondent clinical and imaging data to use, as fresh blood tissues or frozen stored tissues from lung cancer patients and controls obtained from the Division of Thoracic Surgery and LDCT lung-cancer screening program
时间窗: 01 Jan 2018 - 01 Jan 2023
1.1 : Obtaining biological material from cancer cases and controls (clinical cases) and store in the biobank with clinical data and imaging for bio radiomic analysis. 1.2 : Identification and testing of methods of recruiting high-risk individuals for a lung-cancer screening program using available database to select very high risk individuals; 1.3 : Obtaining biological material from asymptomatic screening-detected cancer cases and controls and store in the biobank with clinical data and imaging. 1.4 : Assessment of compliance of the recruited population and assessment of mean lung-cancer risk. Verify the potential impact of molecular markers as a pre-screening test to better assess the risk of subjects, evaluate the impact on nodule management and number of false positive cases among screening process according to biostatistical analysis.
次要结局
- Tumor antigens identified by RPPA in lung cancer circulating exosome(01 Jan 2018 - 01 Jan 2023)
- Investigate the potential role of CTCs as diagnostic and prognostic tool in a screening content(01 Jan 2018 - 01 Jan 2023)
- Development and validation of a panel of mutations on circulating DNA as diagnostic test for lung cancer.(01 Jan 2018 - 01 Jan 2023)
- Investigate a radiomic signature to discriminate malignant lung nodule Background(01 Jan 2018 - 01 Jan 2023)