Lung Diseases, InterstitialNCT02501668
The Prevalence of Lung Cancer in Patients With Interstitial Lung Disease
An observational study of Lung Diseases, Interstitial and Lung Cancer, run by Keimyung University Dongsan Medical Center.
Trial summary
The investigators will evaluate the prevalence of lung cancer associated with interstitial lung disease (ILD) and idiopathic pulmonary fibrosis (IPF) utilizing the Korean Health Insurance Review and Assessment Service (HIRA) database, spanning the period from January 2011 to December 2011. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Lung Diseases, Interstitial, Lung Cancer
- How many people
- 1,375,842 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a retrospective cohort study based on data collected from the HIRA national database. HIRA is a government-affiliated organization that builds an accurate claims review and is a quality assessment system for the National Health Insurance (NHI). The NHI is the only public medical insurance system operated by the Ministry of Health and Welfare in Korea. Korean Health Insurance Review and Assessment Service (HIRA) provided sample database, spanning the period from January 2011 to December 2011. The database (HIRA-NPS-2011-0001) was based on random sampling of outpatients from whole population. The sample cases are total 1,375,842. Among them 670,258 cases (age > 40) were evaluated.
Who may be able to join
- equal to above 40 years old
Who cannot join
- none
About this study
The investigators will evaluate the prevalence of lung cancer associated with interstitial lung disease (ILD) and idiopathic pulmonary fibrosis (IPF) utilizing the Korean Health Insurance Review and Assessment Service (HIRA) database, spanning the period from January 2011 to December 2011. The database (HIRA-NPS-2011-0001) was based on random sampling of outpatients from whole population. Patients with ILDs, IPF, connective tissue disorder (CTD), and COPD were identified based on the International Classification of Disease-10 (ICD-10) diagnostic codes.
Read the detailed description
The epidemiology of lung cancer related to interstitial lung disease (ILD) with or without with connective tissue disease (CTD) as well as idiopathic pulmonary fibrosis (IPF) has not been well established yet. Interstitial lung disease has a potential to develop lung cancer in the name of scar cancer. The investigators aimed to explore prevalence of lung cancer in patients with ILD with or without CTD and IPF in comparison with chronic obstructive pulmonary disorder (COPD).
The investigators will evaluate the prevalence of lung cancer associated with ILD and IPF utilizing the Korean Health Insurance Review and Assessment Service (HIRA) database, spanning the period from January 2011 to December 2011. The database (HIRA-NPS-2011-0001) was based on random sampling of outpatients from whole population. The sample cases are total 1,375,842. Among them 670,258 cases (age > 40) were evaluated. Patients with ILDs, IPF, CTD, and COPD will be identified based on the International Classification of Disease-10 (ICD-10) diagnostic codes.
- Conditions
- Lung Diseases, Interstitial, Lung Cancer
- Medical subject headings
- Lung Diseases, Interstitial, Lung Neoplasms
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 |
|---|---|---|
| Lung cancer in population | Lung cancer cases in sample population (670,258 cases) | |
| COPD in population | COPD cases (670,258 cases) | |
| COPD with lung cancer | Lung cancer in COPD | |
| ILD without IPF | Interstitial lung disease (ILD) cases without idiopathic pulmonary fibrosis (IPF) | |
| ILD with lung cancer | Lung cancer cases in ILD | |
| Idiopathic pulmonary fibrosis | Idiopathic pulmonary fibrosis cases | |
| IPF with lung cancer | Lung cancer cases in IPF patients | |
| Connective tissue disorder with ILD | CTD with ILD cases | |
| CTD ILD with lung cancer | Lung cancer cases in CTD with ILD | |
| CTD without ILD | CTD with ILD cases in sample population | |
| CTD without ILD with lung cancer | Lung cancer in CTD without ILD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung cancer prevalence
Lung cancer prevalence in different groups
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Diseases, InterstitialStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,375,842 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won-Il Choi, Keimyung University Dongsan Medical Center
- Investigators
- Won-Il Choi, MD, Principal investigator, Keimyung Unversity Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501668
- Sponsor's protocol ID
- 2015-05-005
- Status last verified
- Jul 2015
- First submitted
- 11 Jul 2015
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Lung Cancer in Patients With Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT02501668
- Acronym / sponsor ID
- 2015-05-005
- Conditions
- Lung Diseases, Interstitial, Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,375,842 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 17 Jul 2015 (estimated)
- 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 investigators will evaluate the prevalence of lung cancer associated with interstitial lung disease (ILD) and idiopathic pulmonary fibrosis (IPF) utilizing the Korean Health Insurance Review and Assessment Service (HIRA) database, spanning the period from January 2011 to December 2011. The database (HIRA-NPS-2011-0001) was based on random sampling of outpatients from whole population. Patients with ILDs, IPF, connective tissue disorder (CTD), and COPD were identified based on the International Classification of Disease-10 (ICD-10) diagnostic codes.
Detailed description
The epidemiology of lung cancer related to interstitial lung disease (ILD) with or without with connective tissue disease (CTD) as well as idiopathic pulmonary fibrosis (IPF) has not been well established yet. Interstitial lung disease has a potential to develop lung cancer in the name of scar cancer. The investigators aimed to explore prevalence of lung cancer in patients with ILD with or without CTD and IPF in comparison with chronic obstructive pulmonary disorder (COPD).
The investigators will evaluate the prevalence of lung cancer associated with ILD and IPF utilizing the Korean Health Insurance Review and Assessment Service (HIRA) database, spanning the period from January 2011 to December 2011. The database (HIRA-NPS-2011-0001) was based on random sampling of outpatients from whole population. The sample cases are total 1,375,842. Among them 670,258 cases (age > 40) were evaluated. Patients with ILDs, IPF, CTD, and COPD will be identified based on the International Classification of Disease-10 (ICD-10) diagnostic codes.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Lung cancer in population | – | –Lung cancer cases in sample population (670,258 cases) |
| COPD in population | – | –COPD cases (670,258 cases) |
| COPD with lung cancer | – | –Lung cancer in COPD |
| ILD without IPF | – | –Interstitial lung disease (ILD) cases without idiopathic pulmonary fibrosis (IPF) |
| ILD with lung cancer | – | –Lung cancer cases in ILD |
| Idiopathic pulmonary fibrosis | – | –Idiopathic pulmonary fibrosis cases |
| IPF with lung cancer | – | –Lung cancer cases in IPF patients |
| Connective tissue disorder with ILD | – | –CTD with ILD cases |
| CTD ILD with lung cancer | – | –Lung cancer cases in CTD with ILD |
| CTD without ILD | – | –CTD with ILD cases in sample population |
| CTD without ILD with lung cancer | – | –Lung cancer in CTD without ILD |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a retrospective cohort study based on data collected from the HIRA national database. HIRA is a government-affiliated organization that builds an accurate claims review and is a quality assessment system for the National Health Insurance (NHI). The NHI is the only public medical insurance system operated by the Ministry of Health and Welfare in Korea. Korean Health Insurance Review and Assessment Service (HIRA) provided sample database, spanning the period from January 2011 to December 2011. The database (HIRA-NPS-2011-0001) was based on random sampling of outpatients from whole population. The sample cases are total 1,375,842. Among them 670,258 cases (age > 40) were evaluated.
Key inclusion criteria (1 listed)
- equal to above 40 years old
Key exclusion criteria (1 listed)
- none
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 prevalence
Time frame: Up to 12 months
Lung cancer prevalence in different groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2015.
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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. This study is not recruiting at the moment.
Won-Il Choi, MD principal investigator
Keimyung Unversity Dongsan Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases, Interstitial and Lung Cancer, run by Keimyung University Dongsan Medical Center.
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 1 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: finished, as of the sponsor's last update on 17 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung cancer prevalence (time frame: Up to 12 months). 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 17 Jul 2015.