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Deployment-Related Lung Disease Research Database and Biorepository

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03035097
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : April 20, 2018
Information provided by (Responsible Party):
Jennifer Brandorff, National Jewish Health

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.

Condition or disease Intervention/treatment
Bronchiolitis Other: Biorepository

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 1 Day
Official Title: Deployment-Related Lung Disease Research Database and Biorepository
Study Start Date : February 2013
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases

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

Primary Outcome Measures :
  1. collect symptom and exposure data [ Time Frame: Up to 24 months ]
    each subject will complete a questionnaire

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Inclusion Criteria:

  • Served in the southwest Asia wars

Exclusion Criteria:

  • Did not served in the southwest Asia wars

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03035097

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Contact: Jenna Wolff, BS 303-398-1418

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United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Jenna Marcotte, BS    303-398-1418   
Sponsors and Collaborators
National Jewish Health

Additional Information:

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Responsible Party: Jennifer Brandorff, Regulatory Manager, National Jewish Health Identifier: NCT03035097     History of Changes
Other Study ID Numbers: HS-2689
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases, Obstructive
Respiratory Tract Infections