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

NCT ID: NCT06690385

Last Updated: 2024-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1998 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-14

Study Completion Date

2024-11-13

Brief Summary

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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

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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.

Conditions

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Lung Cancer COPD Emphysema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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%.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

OTHER

Sponsor Role lead

Responsible Party

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Carolina Maria Gotera Rivera

Pneumologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carolina Gotera, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Locations

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Fundación Jimenez Díaz Universitary Hospital

Madrid, , Spain

Site Status RECRUITING

Pneumology department. Fundación Jimenez Díaz University Hospital

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Carolina Gotera, MD

Role: CONTACT

+34 915504800 ext. 4954

María Jesús Rodríguez Nieto, MD phD

Role: CONTACT

+34 915504800 ext. 4954

Facility Contacts

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Carolina Gotera, PI

Role: primary

+34915504800 ext. 4954

María Jesús Rodríguez Nieto, SI

Role: backup

+34 915504800 ext. 4954

Carolina Gotera, PI

Role: primary

+34915504800 ext. 4954

María Jesús Rodríguez Nieto, SI

Role: backup

+34 915504800 ext. 4954

Other Identifiers

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ER2_EO180-19_FJD-HGV

Identifier Type: -

Identifier Source: org_study_id

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