Airway Disease, Barrett Esophagus, Gastroesophageal Reflux Disease
Conditions
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.
Interventions
None listed
Sponsors
NYU Langone Health
National Institute for Occupational Safety and Health (NIOSH/CDC)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
37 Years to 90 Years
Healthy volunteers
No
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\*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnna Nolan, MD
NYU Langone Health
Outcome results
None listed