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NCT Number: NCT06690385

DEPRECAP: Lung Cancer Screening Programme by LDCT for Patients With 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)

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Key information

Conditions

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

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fundación Jimenez Díaz Universitary Hospital, Madrid, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Carolina Gotera, MD

CONTACT

[email protected]

+34 915504800 ext. 4954

María Jesús Rodríguez Nieto, MD phD

CONTACT

[email protected]

+34 915504800 ext. 4954

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Other

Registry information

Official study 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.

Acronym: DEPRECAP

Important dates

Study start
2014
Primary completion
2024
Study completion
2024
First posted
Nov 15, 2024
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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