Deployment-Related Lung Disease Research Database and Biorepository

November 7, 2023 updated by: Cecile Rose Professor of Medicine, National Jewish Health
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80206
        • Recruiting
        • National Jewish Health
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • Served in the southwest Asia wars

Exclusion Criteria:

  • Did not served in the southwest Asia wars

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
collect symptom and exposure data
Time Frame: Up to 24 months
each subject will complete a questionnaire
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Jewish Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

January 4, 2017

First Submitted That Met QC Criteria

January 25, 2017

First Posted (Estimated)

January 27, 2017

Study Record Updates

Last Update Posted (Actual)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-2689

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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