Deployment-Related Lung Disease Research Database and Biorepository

Bronchiolitis Clinical Trial

Official title:

Deployment-Related Lung Disease Research Database and Biorepository

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03035097
• Other study ID #: HS-2689
• Status: Recruiting
• Start date: February 2013
• Est. completion date: December 2030

Study information

• Verified date: November 2023
• Source: National Jewish Health
• Contact: Lauren Zell-Baran, PhD, MPH
• Phone: 303-398-1187
• Email: zell-baranl[@]njhealth.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this research study is to establish a research database and biorepository for patients at National Jewish Health (NJH) who served in Operation Iraqi Freedom (OIF) or Operation Enduring Freedom (OEF). This study will also include civilian contractors who worked as part of these military operations in Iraq or Afghanistan. The biorepository would store blood samples obtained from these patients during a clinic visit. The research database would store prospectively and retrospectively collected clinical and exposure data that would enable us to comprehensively characterize each case.

Description:

If informed consent is obtained, test results and other information collected for clinical reasons will be entered in a research database designed and maintained by DEOHS staff. The clinical data collected are part of the routine diagnosis and care of these patients. No additional procedures are required for the purpose of this research database. Collection of symptom and exposure data using a questionnaire designed for this study.

All NJH patients who served in southwest Asia will be approached for inclusion in the study. This will also attempt to contact patients evaluated previously at NJH for deployment-related lung disease to obtain informed consent to include data from their medical record and the research questionnaire in the database.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Served in the southwest Asia wars

Exclusion Criteria:

• Did not served in the southwest Asia wars

Related Conditions & MeSH terms

• Bronchiolitis
• Lung Diseases

Intervention

Other:
• Biorepository
One-time blood draw for blood to be stored in a biorepositoy

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
National Jewish Health

Country where clinical trial is conducted

United States, 

References & Publications (2)

Krefft SD, Wolff J, Zell-Baran L, Strand M, Gottschall EB, Meehan R, Rose CS. Respiratory Diseases in Post-9/11 Military Personnel Following Southwest Asia Deployment. J Occup Environ Med. 2020 May;62(5):337-343. doi: 10.1097/JOM.0000000000001817. — View Citation

Zell-Baran LM, Meehan R, Wolff J, Strand M, Krefft SD, Gottschall EB, Macedonia TV, Gross JE, Sanders OL, Pepper GC, Rose CS. Military Occupational Specialty Codes: Utility in Predicting Inhalation Exposures in Post-9/11 Deployers. J Occup Environ Med. 2019 Dec;61(12):1036-1040. doi: 10.1097/JOM.0000000000001731. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	collect symptom and exposure data	each subject will complete a questionnaire	Up to 24 months