Clinical trial NCT06690385: DEPRECAP: Lung Cancer Screening Programme by LDCT for Patients With COPD or Emphysema.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
COPD
Emphysema
Keywords: Lung cancer screening
Low-dose computed CT
COPD
Emphysema
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 1998
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All those patients who agree to be part of the DEPRECAP programme registry corresponding to the reference population of the Fundación Jiménez Díaz and General de Villalba hospitals in the Community of Madrid (Spain).

Brief summary: 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)

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Lung cancer screening
timeFrame: 15 years
Secondary outcomes:
measure: Lung cancer screening
timeFrame: 15 years
measure: Lung cancer screening: smoking cessation
timeFrame: 15 years
Other outcomes:
measure: Lung cancer screening: comorbidities associated
timeFrame: 15 years
Locations:
city: Madrid
country: Spain
facility: Fundación Jimenez Díaz Universitary Hospital
city: Madrid
country: Spain
facility: Pneumology department. Fundación Jimenez Díaz University Hospital
Study officials:
affiliation: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
name: Carolina Gotera, MD
role: PRINCIPAL_INVESTIGATOR
References: