The Prevalence of Lung Cancer in Patients With Interstiti... | NCT02501668

Studies
The Prevalence of Lung Cancer in Patients With Interstitial Lung Disease

NCT02501668

Sponsor

Keimyung University Dongsan Medical Center

Status

Completed

Last Update Posted

Jul 17, 2015Estimated

Enrollment

1,375,842Actual

Phase

Not provided

Conditions

Lung Diseases, Interstitial
Lung Cancer

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Jul 11, 2015

First Submission Date that Met QC Criteria

Jul 16, 2015

First Posted Date

Jul 17, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2015

Last Update Posted Date

Jul 17, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Won-Il Choi, Assoicate Professor, Keimyung University Dongsan Medical CenterPrincipal Investigator

Lead Sponsor

Keimyung University Dongsan Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,375,842Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lung cancer prevalence	Lung cancer prevalence in different groups	Up to 12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

equal to above 40 years old

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Won-Il Choi, MD	Keimyung Unversity Dongsan Medical Center	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017563	Lung Diseases, Interstitial
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms

Browse Leaves

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Browse Branches

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