DEPRECAP: Lung Cancer Screening Programme by LDCT for Patients With COPD or Emphysema.

NCT06690385 | Recruiting DMC

• 1 other identifier: ER2_EO180-19_FJD-HGV
• Study Type: observational
• Target: 1,998
• Locations: 1 country
• Sites: 2

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)

Conditions

Lung Cancer; COPD; Emphysema

Keywords

Lung cancer screening; Low-dose computed CT; COPD; Emphysema

Outcome Measures

Primary Outcomes (1)

• Lung cancer screening

  Creation of a multi-centre pilot lung cancer screening programme targeting high-risk subjects. with COPD and emphysema.

  15 years

Secondary Outcomes (2)

• Lung cancer screening

  15 years

• Lung cancer screening: smoking cessation

  15 years

Other Outcomes (1)

• Lung cancer screening: comorbidities associated

  15 years

Study Arms (1)

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%.

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead

Study Sites (2)

Fundación Jimenez Díaz Universitary Hospital

Madrid, 28040, Spain

RECRUITING

Pneumology department. Fundación Jimenez Díaz University Hospital

Madrid, 28040, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biological samples: serum, plasma and whole blood obtained at inclusion and during follow-up.

MeSH Terms

Conditions

Lung Neoplasms; Pulmonary Disease, Chronic Obstructive; Emphysema

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carolina Gotera, MD

  Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolina Gotera, MD

CONTACT

+34 915504800; carolina.gotera@fjd.es

María Jesús Rodríguez Nieto, MD phD

CONTACT

+34 915504800; mjrodriguezn@fjd.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 40 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pneumologist

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 15, 2024
• Study Start: January 14, 2014
• Primary Completion: November 13, 2024
• Study Completion: November 13, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)