NCT03035097

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Feb 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Feb 2013Dec 2030

Study Start

First participant enrolled

February 1, 2013

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
13.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

17.8 years

First QC Date

January 4, 2017

Last Update Submit

April 10, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • collect symptom and exposure data

    each subject will complete a questionnaire

    Up to 24 months

Interventions

One-time blood draw for blood to be stored in a biorepositoy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Served in the southwest Asia wars

You may not qualify if:

  • Did not served in the southwest Asia wars

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

RECRUITING

Related Publications (2)

  • 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.

    PMID: 31592941BACKGROUND
  • 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.

    PMID: 31977922BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

If patients consent to having blood and tissue collected for the biorepository, the samples will be collected during a clinic visit. Two DNA PAXgene tubes will be used to collect 17ml of blood and two RNA PAXgene tubes would be used to collect 5 ml of blood. In addition, excess bronchoalveolar lavage (BAL) fluid from a clinically-indicated bronchoscopy would also be collected. Blood and BAL fluid will be frozen and stored in -80 degree C freezers in the Occupational Medicine Laboratory until processed. If a patient will have a surgical or transbronchial biopsy as part of his or her clinical evaluation, any excess lung tissue that has been formalin-fixed and paraffin-embedded will also be collected and stored in the Occupational Medicine facilities.

MeSH Terms

Conditions

Bronchiolitis

Interventions

Biological Specimen Banks

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Intervention Hierarchy (Ancestors)

Health FacilitiesHealth Care Facilities Workforce and Services

Central Study Contacts

Lauren Zell-Baran, PhD, MPH

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 4, 2017

First Posted

January 27, 2017

Study Start

February 1, 2013

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations