Volatolomic and Proteomic Profile; Breath, Urine and Serum as Non-invasive Tools for Early Diagnosis of Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Comparison of the proteomic and volatolomic signature in samples of respiratory exhalation, serum, and urine from patients with lung cancer (stage I/II) and healthy individuals at high risk.
研究概览
简要总结
The goal of this prospective, case-control study is to discover the specific "omics" biomarkers of early stage of lung cancer using the non-invasive samples (breath, urine and serum) in a total of 200 subjects (100 healthy controls and 100 lung cancer patient). The main questions it aims to answer are:
- Which are the "omics" biomarkers that characterize the early stage of lung cancer?
- How to Translate Laboratory Data into Clinical Data?
For each participant we will collected the breath, urine and blood samples. In lung cancer patients group the samples will be sample before lung cancer resection. The samples of Breath, urine and serum will be analysed using different type of analysis: eNose and the Gas Chromatography combined with Ion Mass Spectrometry (GC/IMS). Moreover, Serum will be analyzed by mass-spectrometry-based proteomics. The purpose of these analyses will be to find biomarkers capable of distinguishing the early-stage of lung cancer from the healthy group. Followup will be performed to evaluate the possible change of the volatolomic and proteomic profile.
详细描述
All partecipants will sign the Informed Consent before the sampling procedures. In addition, they will complete the clinical questionnaire containing medical history, smoking history and psychological evaluation.We will conduct the trial according to the ICH Good Clinical Practice (GCP) guidelines. Keeping accurate and consistent records is essential to a cooperative study.The IEO Data Management Office will responsible of the study database and data management.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Lung cancer group
- •Diagnosis of early stage - lung cancer
- •Signed Informed Consent
- •Completed questionnaire
- •Healthy subjects
- •high risk individuals (heavy smokers, subjects with pulmonary disease non-cancer related or with a familiar history of lung cancer disease)
- •Recent (within 6 months) negative Chest X-ray or CT scan
排除标准
- •Both groups
- •No previous chemo or radiotherapy for lung cancer
- •No previous malignancies within last 5 years
- •No abuse of alcohol (no more than 1 litre of wine for day).
- •No patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study
结局指标
主要结局
Comparison of the proteomic and volatolomic signature in samples of respiratory exhalation, serum, and urine from patients with lung cancer (stage I/II) and healthy individuals at high risk.
时间窗: 12 months
Enrolling two cohorts at baseline: healthy individuals at high risk with negative LDCT (no suspicious oncological findings) vs. patients with early-stage I/II lung cancer candidates for surgical resection; sampling in lung cancer patients will be performed pre-intervention. We will assess and compare the serum and urinary proteomic and volatile organic compound profiles, serum and respiratory, of the two cohorts under study at baseline and changes in proteomic and volatile organic compound signature at 12 months from baseline.
次要结局
- Omics-Data intagration.(6 months)