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Enrolling by Invitation

NCT Number: NCT05216133

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

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.

Enrolling by Invitation

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Key information

Conditions

Airway Disease Barrett Esophagus Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastroesophageal Reflux Disease Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

37 year–90 year

Sex eligibility

Male

Study type

Observational

Primary location

NYU Clinical & Translational Science Institute Clinical Research Center (CTSI CRC)

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

  • 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*

Treatment and study plan

Primary outcomes

  1. Levels of salivary pepsin

    Time frame: up to Day 365

    Saliva will be analyzed using the Peptest. The value of >/= 16 ng/mL indicates a positive salivary pepsin.

  2. pH Levels from Exhaled Breath Condensate (EBC)

    Time frame: up to Day 365

    EBC pH assay will be performed

  3. Histamine Concentration from Exhaled Breath Condensate (EBC)

    Time frame: up to Day 365

    Histamine concentration will be measured with an enzymatic immunoassay

  4. Score on Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL) Questionnaire

    Time frame: 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.

  5. Score on Patient Assessment of Upper Gastrointestinal Disorders-Symptoms (PAGI-SYM) Questionnaire

    Time frame: 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.

  6. Score on St. George's Respiratory Questionnaire (SGRQ-C)

    Time frame: 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.

  7. 36-Item Short Form Survey Instrument (SF-36)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute for Occupational Safety and Health (NIOSH/CDC)

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 31, 2022
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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