Biomarkers of Airway Disease, Barrett's and Underdiagnosed Reflux Noninvasively (BADBURN)

Launched by NYU LANGONE HEALTH · Jan 18, 2022

Keywords

ClinConnect Summary

No description provided

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 37-90
• • 2. FDNY rescue and recovery worker.
• • 3. Male\*
• • 4. Documented WTC exposure.
• • 5. Consented/Enrolled in the FDNY WTC Health Program
• • 6. Subjects are willing and able to consent for themselves to study enrollment
• • 7. Subjects are willing and able to participate in study procedures
• • 8. Are able to perform their activities of daily living independently
• • 9. Are either light duty or retired FDNY Firefighters
• • 10. Spirometry available within the last 24 months, and at a post-9/11 visit.
• • 11. Have means to accommodate transportation to/from in-person visit Are able to attend a single visit at the CTSI (462 1st Avenue, C \& D 4th Floor)
• • 12. Pre-9/11 spirometry with FEV1%predicted ≥LLN and if not available 1st -post 9/11 spirometry with an FEV1 \>80% predicted.
• • 13. Exposure at the WTC-site within 2 weeks of the 9/11/2001
• • 14. Entered WTC-HP before the site closure on 7/24/2002.
• • 15. Serum from their first post 9/11 WTC-HP visit is available in the FDNY WTC biorepository and may be assayed
• • 16. Are not currently being treated for malignancy
• • 17. Subjects will either need to be defined as having WTC-AHR, WTC-GERD, WTC-BE or be designated controls as per the following additional inclusion criteria are specific to the WTC-aerodigestive disease that the subjects have
• • 18. AHR--A positive methacholine (PC20\<16) and/or positive bronchodilator response (ATS/ERS guidelines: improvement of FEV1 by 12% and at least 200mL) at least once post-9/11.\[95, 96\]No recorded positive AHR testing prior to 9/11
• • 19. GERD Inclusion Criteria
• • Erosive esophagitis LA grade C or D (as described on endoscopy), OR
• • Stricture or Barrett's esophagus on endoscopy, OR
• • Esophageal acid exposure time \>6% on a pH or pH impedance study
• • 19. BE Inclusion Criteria
• • Columnar epithelium lining ≥1 cm of the distal esophagus. AND
• • Histologic examination of biopsy specimens from that columnar epithelium must reveal intestinal metaplasia characterized with goblet cells.
• Exclusion Criteria:
• • 1. Unwilling to complete an informed consent.
• • 2. Not enrolled in the WTC-HP
• • 3. Do not meet eligibility criteria for AIM 1 or did not have serum available in the biorepository from the first post 9/11 WTC-HP visit.
• • 4. Have pre-existing and documented conditions or concurrent diagnoses, including (and not necessarily limited to) active cancer, severe heart disease, significant cognitive impairment, eating disorders, significant psychiatric illness, end-stage COPD, severe pulmonary hypertension, or organ transplant.
• • 5. High dose steroid (\>20mg prednisone or equivalent) or other hormonal treatments/chemotherapy use in the last month, including testosterone supplementation.
• • 6. Life-expectancy \< 6 months
• • 7. Female\*