Identification of Diagnostic and Prognostic Biomarkers in the Pathological Continuum of Bronco Chronic Obstructive Pulmonary Disease, Idiopathic Pulmonary Fibrosis and Pulmonary Neoplasia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Innate immunity
研究概览
简要总结
Primary Objective:
To evaluate the association between inflammatory, immunological, genetic, and epigenetic biomarkers measured at enrollment and the clinical, functional, and phenotypic characteristics of patients with chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), and lung cancer.
Secondary Objective:
To assess the prognostic value of the identified biomarkers by evaluating their ability to predict clinical outcomes at 12 months.
Primary Outcome Measure:
Association between baseline inflammatory, immunological, genetic, and epigenetic biomarkers and disease-specific clinical, functional, and phenotypic characteristics assessed at enrollment, including:
COPD: current or former smokers, stratified according to the predominant phenotype (emphysema or bronchiolitis); IPF: rapid progressors, slow progressors, and patients with combined pulmonary fibrosis and emphysema (CPFE); Lung cancer: current smokers, former smokers who quit less than 15 years before enrollment, former smokers who quit 15 years or more before enrollment, and never-smokers.
Secondary Outcome Measure:
Predictive performance of baseline inflammatory, immunological, genetic, and epigenetic biomarkers for 12-month clinical outcomes.
详细描述
This is a non-profit, interventional pilot study without an investigational medicinal product. The study consists of two phases: a prospective phase (Phase I) and a retrospective phase (Phase II).
Study Timeline
The overall study duration will be 30 months, as follows:
Patient enrollment and biological sample collection: 18 months. Follow-up visit: 12 months after enrollment for each participant. Laboratory analyses: 20 months. Statistical analyses: at Month 24 (primary endpoint) and at Month 30 (12-month follow-up analyses).
Phase I - Prospective
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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.
- •Clinical diagnosis of: Chronic Obstructive Pulmonary Disease (COPD), current or former smokers; and/or Idiopathic Pulmonary Fibrosis (IPF), current or former smokers; and/or Resectable lung adenocarcinoma (Stage I-III, according to clinical indication for surgical resection).
- •Ability to comply with study procedures and follow-up visits.
排除标准
- •Inability or unwillingness to provide informed consent.
- •Active respiratory infection or acute exacerbation of COPD or IPF at the time of enrollment.
- •Previous or concomitant malignant disease (except non-melanoma skin cancer) that could interfere with study objectives.
- •Prior systemic immunosuppressive or anti-inflammatory therapy that may significantly alter immune profiling within a defined washout period (if applicable per protocol).
- •Severe comorbid conditions limiting life expectancy or ability to complete follow-up (e.g., advanced heart failure, severe renal or hepatic disease).
- •Inadequate biological sample quality or impossibility to obtain required blood samples.
结局指标
主要结局
Innate immunity
时间窗: Baseline
Macrophages, monocytes, neutrophils, and dendritic cells (for all: % of total blood cells)
Genetic polymorphisms
时间窗: baseline
KIR, HLA-Cw, VDR, GC1, IL-1β, IL-1Ra, IL-6, IL-10, IL-13, IL-18, TGF-β1, TNF-α (for all: presence or absence)
Adaptive immunity
时间窗: baseline
CTLA-4, PD-1, PDL-1, PDL-2, Galectin-9, LAG-3, TIM-3, VISTA, TIGIT, IL-10, TGF-β, IL-13, IL-35, IL-17 IL-21, IL-1β, IL-6, IL-23, IL-22 (for all: ng/ml)
serum microRNAs
时间窗: baseline
serum miR-155-5p, miR-146a-5p, miR-181a-5p, miR-223-3p, miR-431-5p, miR-149-3p, miR-335-5p and miR-206 (for all: copies/ul)
Forced Expiratory Volume in 1 second
时间窗: baseline and after 12 months
Forced Expiratory Volume in 1 second (FEV1) (%)
VC
时间窗: baseline and after 12 months
Vital Capacity (VC) (%)
Total Lung Capacity
时间窗: baseline and after 12 months
Total Lung Capacity (TLC) (%)
Inspiratory Capacity
时间窗: baseline and after 12 months
Inspiratory Capacity (IC) (%)
Expiratory Reserve Volume
时间窗: Baseline and after 12 months
Expiratory Reserve Volume (ERV) %)
Residual Volume
时间窗: Baseline and after 12 months
Residual Volume (RV) (%)
Diffusing Capacity of the Lung for Carbon Monoxide / Alveolar Volume
时间窗: Baseline and after 12 months
Diffusing Capacity of the Lung for Carbon Monoxide / Alveolar Volume (DLCO/AV) (%)
Blood gas analysis - PaO2
时间窗: Baseline and after 12 months
PaO2 (mmHg)
Blood gas analysis - PaCO2
时间窗: baseline and after 12 months
PaCO2 (mmHg)
Test 6 minute walk
时间窗: baseline and after 12 months
Test 6 minute walk (metres)
次要结局
未报告次要终点