Controls for Respiratory Diseases

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03120481
• Collaborator: (none)
• Enrollment: 1,572
• Location: 1
• Anticipated Duration (Months): 238.7
• Patients Per Site Per Month: 6.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease; Asthma; Idiopathic Pulmonary Fibrosis; Nontuberculous Mycobacterium Infection; Bronchiectasis; Lung Cancer	Other: no intervation

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 1572 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Registry of Controls for Respiratory Diseases
• Actual Study Start Date: Apr 10, 2017
• Anticipated Primary Completion Date: Feb 28, 2037
• Anticipated Study Completion Date: Feb 28, 2037

Arms and Interventions

Arm	Intervention/Treatment
Normal control	Other: no intervation; no intervention

Outcome Measures

Primary Outcome Measures

1. Mortality [20 years]

   Death

Secondary Outcome Measures

1. Hospitalization [20 years]

   All cause hospitalization

2. Respiratory hospitalization [20 years]

   Hospitalization from respiratory causes

3. Respiratory diseases diagnosis [20 years]

   Respiratory diseases diagnosis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Healthcare System Gangnam Center	Seoul		Korea, Republic of	06236

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Principal Investigator: Chang-Hoon Lee, M.D., Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chang-Hoon Lee, Associate professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT03120481
• Other Study ID Numbers: 2016-3435
• First Posted: Apr 19, 2017
• Last Update Posted: Apr 19, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Mycobacterium Infections; Mycobacterium Infections, Nontuberculous; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Bronchiectasis; Respiration Disorders; Respiratory Tract Diseases

Study Results

No Results Posted as of Apr 19, 2017