Registry of Patients Included in the DEPRECAP (Lung Cancer Screening Porgramme by Low-dose Computed Tomography for Patients With Chronic Obstructive Pulmonary Disease (COPD) or Emphysema.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,998
- 试验地点
- 2
- 主要终点
- Lung cancer screening
研究概览
简要总结
The DEPRECAP (Early detection of lung cancer) study is an ongoing, prospective, longitudinal, multicenter lung cancer screening program that recruited individuals with COPD or emphysema from the pulmonary clinics of Fundación Jiménez Díaz University Hospital and Villalba General Hospital, in Madrid, Spain.
The aim of this observational study is to determine the scientific evidence needed to study the benefit and potential effects of lung cancer screening in this group of patients and to determine the long-term effects of the intervention in reducing the high mortality rates associated with late-stage lung cancer diagnosis in a very high-risk population, to address under-diagnosis of COPD and to promote smoking cessation. This leads to the creation of a registry with clinical, radiological, functional data and biological samples for future studies in this cohort of patients to provide the scientific evidence needed to study the benefit and potential effects of screening for lung cancer and other tobacco-related pathologies diagnosed by Low-dose CT (LDCT)
详细描述
Participants who met the inclusion/exclusion criteria detailed below and agreed to participate, underwent annual LDCT and pulmonary function tests until age 75 or 15 years of smoking abstinence, whichever came first. The study protocol was approved by the Ethics Committee of the Fundación Jiménez Díaz (ER2_EO180-19_FJD-HGV) and all participants signed their informed consent.
Inclusion criteria were males or females, 55-75 years of age, current or former smokers (Less than 15 years of abstinence) with a cumulative smoking exposure of greather than 30 pack-years and a diagnosis of COPD according to the GOLD guidelines and/or emphysema identified by LDCT. Individuals with a recent history of cancer (except non-melanoma skin cancer or carcinoma in situ) as well as those with other medical conditions that posed a significant risk of death were excluded.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current or former smokers (>15 years of abstinence) with a cumulative smoking exposure of > 30 pack-years
- •Diagnosis of COPD according to the GOLD guidelines and/or emphysema identified by LDCT and/or a carbon monoxide diffusing capacity (DLCO) lower than 80% of predicted (as per the Global Lung Function Initiative (GLI) equations)
排除标准
- •Individuals with a recent history of cancer (except non-melanoma skin cancer or carcinoma in situ) as well as those with other medical conditions that posed a significant risk of death were excluded from the study.
结局指标
主要结局
Lung cancer screening
时间窗: 15 years
Creation of a multi-centre pilot lung cancer screening programme targeting high-risk subjects. with COPD and emphysema.
次要结局
- Lung cancer screening(15 years)
- Lung cancer screening: smoking cessation(15 years)
研究者
Carolina Maria Gotera Rivera
Pneumologist
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz