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Deployment-Related Lung Disease Research Database and Biorepository

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by National Jewish Health
Sponsor:
Information provided by (Responsible Party):
Jennifer Brandorff, National Jewish Health
ClinicalTrials.gov Identifier:
NCT03035097
First received: January 4, 2017
Last updated: January 25, 2017
Last verified: January 2017
  Purpose
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 Intervention
Bronchiolitis
Other: Biorepository

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 1 Day
Official Title: Deployment-Related Lung Disease Research Database and Biorepository

Resource links provided by NLM:


Further study details as provided by National Jewish Health:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 500
Study Start Date: February 2013
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Biorepository
    One-time blood draw for blood to be stored in a biorepositoy
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
Criteria

Inclusion Criteria:

  • Served in the southwest Asia wars

Exclusion Criteria:

  • Did not served in the southwest Asia wars
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03035097

Contacts
Contact: Jenna Marcotte, BS 303-398-1418 marcottej@njhealth.org
Contact: Cecile Rose, MD 303-398-1867 rosec@njhealth.org

Locations
United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Jenna Marcotte, BS    303-398-1418    marcottej@njhealth.org   
Sponsors and Collaborators
National Jewish Health
  More Information

Responsible Party: Jennifer Brandorff, Regulatory Manager, National Jewish Health
ClinicalTrials.gov Identifier: NCT03035097     History of Changes
Other Study ID Numbers: HS-2689
Study First Received: January 4, 2017
Last Updated: January 25, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

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

ClinicalTrials.gov processed this record on March 29, 2017