DEPRECAP: Lung Cancer Screening Programme by LDCT for Patients With COPD or Emphysema. (DEPRECAP)
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.
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)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Carolina Gotera, MD
- Phone Number: 4954 +34 915504800
- Email: carolina.gotera@fjd.es
Study Contact Backup
- Name: María Jesús Rodríguez Nieto, MD phD
- Phone Number: 4954 +34 915504800
- Email: mjrodriguezn@fjd.es
Study Locations
-
-
-
Madrid, Spain, 28040
- Recruiting
- Fundación Jimenez Díaz Universitary Hospital
-
Contact:
- Carolina Gotera, PI
- Phone Number: 4954 +34915504800
- Email: carolina.gotera@fjd.es
-
Contact:
- María Jesús Rodríguez Nieto, SI
- Phone Number: 4954 +34 915504800
- Email: mjrodriguezn@fjd.es
-
Principal Investigator:
- Carolina Gotera, PI
-
Sub-Investigator:
- María Jesús Rodríguez Nieto, SI
-
Madrid, Spain, 28040
- Recruiting
- Pneumology department. Fundación Jimenez Díaz University Hospital
-
Contact:
- Carolina Gotera, PI
- Phone Number: 4954 +34915504800
- Email: carolina.gotera@fjd.es
-
Contact:
- María Jesús Rodríguez Nieto, SI
- Phone Number: 4954 +34 915504800
- Email: mjrodriguezn@fjd.es
-
Principal Investigator:
- Carolina Gotera, PI
-
Sub-Investigator:
- María Jesús Rodríguez Nieto, SI
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
COPD or Emphysema
COPD according to GOLD guidelines determined by spirometry or pulmonary emphysema on previous chest CT or by CO diffusion test values less than 80%.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lung cancer screening
Time Frame: 15 years
|
Creation of a multi-centre pilot lung cancer screening programme targeting high-risk subjects. with COPD and emphysema. |
15 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lung cancer screening
Time Frame: 15 years
|
To create a multicenter registry of clinical data, radiological images and blood samples to provide scientific evidence to study the benefit of lung cancer screening in patients with COPD or emphysema.
|
15 years
|
|
Lung cancer screening: smoking cessation
Time Frame: 15 years
|
To determine the effect of primary and secondary prevention on smoking cessation as a key element in the follow-up of the patients included.
|
15 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lung cancer screening: comorbidities associated
Time Frame: 15 years
|
Use follow-up in the screening programme to diagnose high-impact comorbidities associated with smoking such as COPD, pulmonary emphysema, bronchiectasis, incipient interstitial lung disease (ILA) or established interstitial lung disease and coronary heart disease.
|
15 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Carolina Gotera, MD, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ER2_EO180-19_FJD-HGV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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