Status:
ENROLLING_BY_INVITATION
Biomarkers of Airway Disease, Barrett's and Underdiagnosed Reflux Noninvasively (BADBURN)
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
National Institute for Occupational Safety and Health (NIOSH/CDC)
Conditions:
Airway Disease
Barrett Esophagus
Eligibility:
MALE
37-90 years
Brief Summary
A majority of Fire Department of New York (FDNY) World Trade Center (WTC) exposed rescue and recovery workers developed gastroesophageal reflux disease (GERD), a risk factor for Barrett's Esophagus (B...
Eligibility Criteria
Inclusion
- Age 37-90
- FDNY rescue and recovery worker.
- Male\*
- Documented WTC exposure.
- Consented/Enrolled in the FDNY WTC Health Program
- Subjects are willing and able to consent for themselves to study enrollment
- Subjects are willing and able to participate in study procedures
- Are able to perform their activities of daily living independently
- Are either light duty or retired FDNY Firefighters
- Spirometry available within the last 24 months, and at a post-9/11 visit.
- 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)
- Pre-9/11 spirometry with FEV1%predicted ≥LLN and if not available 1st -post 9/11 spirometry with an FEV1 \>80% predicted.
- Exposure at the WTC-site within 2 weeks of the 9/11/2001
- Entered WTC-HP before the site closure on 7/24/2002.
- Serum from their first post 9/11 WTC-HP visit is available in the FDNY WTC biorepository and may be assayed
- Are not currently being treated for malignancy
- 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
- 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
- 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
- Unwilling to complete an informed consent.
- Not enrolled in the WTC-HP
- 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.
- 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.
- High dose steroid (\>20mg prednisone or equivalent) or other hormonal treatments/chemotherapy use in the last month, including testosterone supplementation.
- Life-expectancy \< 6 months
- Female\*
Key Trial Info
Start Date :
March 22 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05216133
Start Date
March 22 2023
End Date
July 1 2027
Last Update
June 5 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
NYU Clinical & Translational Science Institute Clinical Research Center (CTSI CRC)
New York, New York, United States, 10016