Clinical trial NCT03035097: Deployment-Related Lung Disease Research Database and Biorepository
Official title: Deployment-Related Lung Disease Research Database and Biorepository
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bronchiolitis
Lead sponsor: National Jewish Health
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who served in the southwest Asia will be approached for inclusion in the study. If patients agree to participate in the biorepository, a one-time blood draw will occur. If the subject has had a previous bronchoscopy or a surgical lung biopsy and has excess samples the study would collect those to add to the biorepository.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Served in the southwest Asia wars

Exclusion Criteria:

* Did not served in the southwest Asia wars

Primary outcomes:
measure: collect symptom and exposure data
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
References:
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.
citation: 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.