Controls for Respiratory Diseases | NCT03120481

Studies
Controls for Respiratory Diseases

NCT03120481

Sponsor

Seoul National University Hospital

Status

Recruiting

Last Update Posted

Apr 19, 2017Actual

Enrollment

1,572Estimated

Phase

Not provided

Conditions

Chronic Obstructive Pulmonary Disease
Asthma
Idiopathic Pulmonary Fibrosis
Nontuberculous Mycobacterium Infection
Bronchiectasis
Lung Cancer

Interventions

no intervation

Countries

South Korea

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

Apr 2017

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 10, 2017Actual

Primary Completion Date

Feb 28, 2037Estimated

Completion Date

Feb 28, 2037Estimated

First Submitted Date

Apr 14, 2017

First Submission Date that Met QC Criteria

Apr 14, 2017

First Posted Date

Apr 19, 2017Actual

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

Apr 14, 2017

Last Update Posted Date

Apr 19, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chang-Hoon Lee, Associate professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

This is the registry of control participants for patients with various respiratory diseases. We screened healthy volunteers who visited Seoul National Hospital Healthcare System Gangnam Center for routine health check-up, and enrolled patients who agree to participate in the study. The participants undergo baseline questionnaires, provide blood specimen and information of the results of health check-up. We will include participants as controls if they have no significant respiratory symptom and no significant radiographic abnormality. The data from this registry will be compared with those from other registry of various respiratory diseases

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

20 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,572Estimated

Label	Type	Description	Intervention Names
Normal control			Other: no intervation

Name	Type	Description	Arm Group Labels	Other Names
no intervation	Other	no intervention	Normal control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	Death	20 years

Secondary Outcomes

Measure	Description	Time Frame
Hospitalization	All cause hospitalization	20 years
Respiratory hospitalization	Hospitalization from respiratory causes	20 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

19-90 years old male and female
underwent health check-up including chest radiography
obtained informed consent

Exclusion Criteria:

those who showed a significant abnormal finding of chest radiography
those who reported a significant respiratory symptoms

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Those who visited the hospital for health check-up, and agree to participate in this study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chang-Hoon Lee, M.D.	Contact	82-2-2072-4743		kauri670@gmail.com

Overall Officials

Name	Affiliation	Role
Chang-Hoon Lee, M.D.	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Healthcare System Gangnam Center	Recruiting	Seoul	Seoul	06236	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D001249	Asthma
D054990	Idiopathic Pulmonary Fibrosis
D009165	Mycobacterium Infections, Nontuberculous
D001987	Bronchiectasis
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided