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RecruitingNCT06690385DEPRECAPUpdated Nov 15, 2024

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

An observational study in Lung Cancer, COPD and Emphysema, sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz. Recruiting at 2 sites in Spain. Open to participants aged 55 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-15.

Sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Started Jan 2014; still recruiting 12 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,998
Ages
55 Years to 75 Years
Sex
All
01

Study 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)

Read the 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.

02

Conditions studied

  • Lung Cancer
  • COPD
  • Emphysema

Keywords

  • Lung cancer screening
  • Low-dose computed CT
  • COPD
  • Emphysema
03

In context

Lung Neoplasms

5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.

This study's planned enrollment of 1,998 is above the median of 200 across 1,434 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz is the lead sponsor of 76 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Current or former smokers (>15 years of abstinence) with a cumulative smoking exposure of > 30 pack-years
  • Diagnosis of 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,998 participants (estimated)
Target follow-up
40 Years
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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%.

06

What researchers measure

Primary outcomes

  1. Lung cancer screening

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

    Time frame: 15 years

Secondary outcomes

  1. Lung cancer screening

    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.

    Time frame: 15 years

  2. Lung cancer screening: smoking cessation

    To determine the effect of primary and secondary prevention on smoking cessation as a key element in the follow-up of the patients included.

    Time frame: 15 years

Other outcomes

  1. Lung cancer screening: comorbidities associated

    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.

    Time frame: 15 years

07

Study locations

2 of 2 sites recruiting
  • Fundación Jimenez Díaz Universitary Hospital
    Madrid, 28040, Spain
    Recruiting
    • Carolina Gotera, PI · Contactcarolina.gotera@fjd.es · +34915504800
    • María Jesús Rodríguez Nieto, SI · Contactmjrodriguezn@fjd.es · +34 915504800
    • Carolina Gotera, PI · Principal investigator
    • María Jesús Rodríguez Nieto, SI · Sub investigator
  • Pneumology department. Fundación Jimenez Díaz University Hospital
    Madrid, 28040, Spain
    Recruiting
    • Carolina Gotera, PI · Contactcarolina.gotera@fjd.es · +34915504800
    • María Jesús Rodríguez Nieto, SI · Contactmjrodriguezn@fjd.es · +34 915504800
    • Carolina Gotera, PI · Principal investigator
    • María Jesús Rodríguez Nieto, SI · Sub investigator
08

References and documents

Individual participant data

Plan to share: No — I haven't decided at the moment.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06690385
Lead sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Responsible party
Carolina Maria Gotera Rivera (Pneumologist, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz) — Principal investigator
First posted
Nov 15, 2024
Start date
Jan 14, 2014
Primary completion
Nov 13, 2024 (estimated)
Completion
Nov 13, 2024 (estimated)
Last update
Nov 15, 2024

Study contacts

Carolina Gotera, MD
Contact
carolina.gotera@fjd.es
+34 915504800 ext. 4954
María Jesús Rodríguez Nieto, MD phD
Contact
mjrodriguezn@fjd.es
+34 915504800 ext. 4954
Carolina Gotera, MD
principal investigator · Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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