A Single Center Observational Study of Biomarkers of Airway Disease, Barrett's and Underdiagnosed Reflux Noninvasively (BADBURN)
Study Details
Study Description
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 (BE) and subsequent esophageal cancer. There is diminished health-related quality of life and productivity associated with aerodigestive diseases such as GERD and BE.
This proposal will leverage the longitudinally phenotyped WTC exposed cohort, validate biomarkers of WTC-aerodigestive disease, and develop novel, noninvasive disease phenotyping of premalignant diseases such as BE, and identify potential targeted therapeutics to improve care.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- Levels of salivary pepsin [up to Day 365]
Saliva will be analyzed using the Peptest. The value of >/= 16 ng/mL indicates a positive salivary pepsin.
- pH Levels from Exhaled Breath Condensate (EBC) [up to Day 365]
EBC pH assay will be performed
- Histamine Concentration from Exhaled Breath Condensate (EBC) [up to Day 365]
Histamine concentration will be measured with an enzymatic immunoassay
- Score on Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL) Questionnaire [up to Day 365]
PAGI-QOL asks about how some of the gastrointestinal problems one may be experiencing (such as pain, discomfort, or other problems) may have affected one's overall quality of life and well-being in the past 2 weeks. PAGI-QOL consists of 30 questions, each scored from 0 (none of the time) to 5 (all of the time). The total score range is 0-150; the higher the score, the less the quality of life and well-being.
- Score on Patient Assessment of Upper Gastrointestinal Disorders-Symptoms (PAGI-SYM) Questionnaire [up to Day 365]
PAGI-SYM asks about the severity of symptoms one may have related one's gastrointestinal problem. The questionnaire consists of 20 symptoms, and each symptom is scored from 0 (none) to 5 (very severe). The total score range is 0-100; the higher the score, the more severe the symptoms.
- Score on St. George's Respiratory Questionnaire (SGRQ-C) [up to Day 365]
SGRQ-C is designed to assess how one's breathing is troubling a participant and how it affects one's life. The questionnaire consists of 14 questions. The total score range is 0-54; the higher the score, the worse the chest trouble.
- 36-Item Short Form Survey Instrument (SF-36) [up to Day 365]
SF-36 captures mental health, general health perception, emotional, and social role functioning. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 37-90
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FDNY rescue and recovery worker.
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Male*
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Documented WTC exposure.
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Consented/Enrolled in the FDNY WTC Health Program
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Subjects are willing and able to consent for themselves to study enrollment
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Subjects are willing and able to participate in study procedures
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Are able to perform their activities of daily living independently
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Are either light duty or retired FDNY Firefighters
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Spirometry available within the last 24 months, and at a post-9/11 visit.
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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)
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Pre-9/11 spirometry with FEV1%predicted ≥LLN and if not available 1st -post 9/11 spirometry with an FEV1 >80% predicted.
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Exposure at the WTC-site within 2 weeks of the 9/11/2001
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Entered WTC-HP before the site closure on 7/24/2002.
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Serum from their first post 9/11 WTC-HP visit is available in the FDNY WTC biorepository and may be assayed
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Are not currently being treated for malignancy
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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
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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
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GERD Inclusion Criteria
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Erosive esophagitis LA grade C or D (as described on endoscopy), OR
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Stricture or Barrett's esophagus on endoscopy, OR
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Esophageal acid exposure time >6% on a pH or pH impedance study
- BE Inclusion Criteria
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Columnar epithelium lining ≥1 cm of the distal esophagus. AND
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Histologic examination of biopsy specimens from that columnar epithelium must reveal intestinal metaplasia characterized with goblet cells.
Exclusion Criteria:
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Unwilling to complete an informed consent.
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Not enrolled in the WTC-HP
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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.
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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.
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High dose steroid (>20mg prednisone or equivalent) or other hormonal treatments/chemotherapy use in the last month, including testosterone supplementation.
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Life-expectancy < 6 months
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Female*
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | NYU Clinical & Translational Science Institute Clinical Research Center (CTSI CRC) | New York | New York | United States | 10016 |
Sponsors and Collaborators
- NYU Langone Health
- National Institute for Occupational Safety and Health (NIOSH/CDC)
Investigators
- Principal Investigator: Anna Nolan, MD, NYU Langone Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-00679