Lung CancerDEPRECAPNCT06690385
DEPRECAP: Lung Cancer Screening Programme by LDCT for Patients With COPD or Emphysema.
An observational study of Lung Cancer and COPD, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Lung Cancer, COPD, Emphysema
- How many people
- 1,998 participants
- Where
- 2 sitesSpain
- Study dates
- 14 Jan 2014to 13 Nov 2024
- How long will I take part?
- 40 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Fundación Jimenez Díaz Universitary Hospital
Madrid, 28040
Carolina Gotera, PI, +34915504800 ext. 4954, carolina.gotera@fjd.es
María Jesús Rodríguez Nieto, SI, +34 915504800 ext. 4954, mjrodriguezn@fjd.es
- Recruiting
Pneumology department. Fundación Jimenez Díaz University Hospital
Madrid, 28040
Carolina Gotera, PI, +34915504800 ext. 4954, carolina.gotera@fjd.es
María Jesús Rodríguez Nieto, SI, +34 915504800 ext. 4954, mjrodriguezn@fjd.es
About this study
Official 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.
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.
- Conditions
- Lung Cancer, COPD, Emphysema
- Keywords
- Lung cancer screening, Low-dose computed CT, COPD, Emphysema
- Medical subject headings
- Lung Neoplasms, Pulmonary Disease, Chronic Obstructive, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Lung cancer screening
Creation of a multi-centre pilot lung cancer screening programme targeting high-risk subjects.
with COPD and emphysema.
Measured: 15 years
Secondary outcomes (2)
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.
Measured: 15 years
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.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start14 Jan 2014
- Primary completion13 Nov 2024 (estimated)
- Study completion13 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,998 participants (estimated)
- Target duration
- 40 Years
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolina Maria Gotera Rivera, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Investigators
- Carolina Gotera, MD, Principal investigator, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690385
- Sponsor's protocol ID
- ER2_EO180-19_FJD-HGV
- Acronym
- DEPRECAP
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I haven't decided at the moment.
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06690385
- Acronym / sponsor ID
- DEPRECAP / ER2_EO180-19_FJD-HGV
- Conditions
- Lung Cancer, COPD, Emphysema
- Keywords
- Lung cancer screening, Low-dose computed CT, COPD, Emphysema
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,998 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- 14 Jan 2014 (actual)
- Primary completion
- 13 Nov 2024 (estimated)
- Study completion
- 13 Nov 2024 (estimated)
- First posted
- 15 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 40 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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%. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Lung cancer screening
Time frame: 15 years
Lung cancer screening: smoking cessation
Time frame: 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Individual participant dataSharing planned: No. I haven't decided at the moment.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carolina Gotera, MD principal investigator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and COPD, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carolina Gotera, MD (+34 915504800 ext. 4954, carolina.gotera@fjd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung cancer screening (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.