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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

AERODIGESTIVE DISEASE IN THE WORLD TRADE CENTER EXPOSED FDNY COHORT: a Single Center Observational Study of Biomarkers of Airway Disease, Barrett's and Underdiagnosed Reflux Noninvasively (BADBURN)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05216133
• Other study ID #: 21-00679
• Status: Enrolling by invitation
• Start date: March 22, 2023
• Est. completion date: July 2024

Study information

• Verified date: August 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 37 Years to 90 Years

Eligibility

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*

Related Conditions & MeSH terms

• Airway Disease
• Barrett Esophagus
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Locations

Country	Name	City	State
United States	NYU Clinical & Translational Science Institute Clinical Research Center (CTSI CRC)	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute for Occupational Safety and Health (NIOSH/CDC)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of salivary pepsin	Saliva will be analyzed using the Peptest. The value of >/= 16 ng/mL indicates a positive salivary pepsin.	up to Day 365
Primary	pH Levels from Exhaled Breath Condensate (EBC)	EBC pH assay will be performed	up to Day 365
Primary	Histamine Concentration from Exhaled Breath Condensate (EBC)	Histamine concentration will be measured with an enzymatic immunoassay	up to Day 365
Primary	Score on Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL) Questionnaire	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.	up to Day 365
Primary	Score on Patient Assessment of Upper Gastrointestinal Disorders-Symptoms (PAGI-SYM) Questionnaire	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.	up to Day 365
Primary	Score on St. George's Respiratory Questionnaire (SGRQ-C)	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.	up to Day 365
Primary	36-Item Short Form Survey Instrument (SF-36)	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.	up to Day 365