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)
Sponsor study identifier
observational
200
1 country
1
Study Start
March 22, 2023
Actual (reported)Primary Completion
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 18, 2022
Actual (reported)January 31, 2022
Actual (reported)March 22, 2023
Actual (reported)June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
pH Levels from Exhaled Breath Condensate (EBC)
EBC pH assay will be performed
up to Day 365
Histamine Concentration from Exhaled Breath Condensate (EBC)
Histamine concentration will be measured with an enzymatic immunoassay
up to Day 365
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
Score on Patient Assessment of Upper Gastrointestinal Disorders-Symptoms (PAGI-SYM) Questionnaire
Male FDNY rescue and recovery workers between the ages of 37 and 90.
NYU Clinical & Translational Science Institute Clinical Research Center (CTSI CRC)
New York, New York, 10016, United States
Javed U, Podury S, Kwon S, Liu M, Kim DH, Fallahzadeh A, Li Y, Khan AR, Francois F, Schwartz T, Zeig-Owens R, Grunig G, Veerappan A, Zhou J, Crowley G, Prezant DJ, Nolan A. Biomarkers of Airway Disease, Barrett's and Underdiagnosed Reflux Noninvasively (BAD-BURN) in World Trade Center exposed firefighters: a case-control observational study protocol. BMC Gastroenterol. 2024 Aug 9;24(1):255. doi: 10.1186/s12876-024-03294-9.
Javed U, Podury S, Kwon S, Liu M, Kim D, Fallah Zadeh A, Li Y, Khan A, Francois F, Schwartz T, Zeig-Owens R, Grunig G, Veerappan A, Zhou J, Crowley G, Prezant D, Nolan A. Biomarkers of Airway Disease, Barrett's and Underdiagnosed Reflux Noninvasively (BAD-BURN): a Case-Control Observational Study Protocol. Res Sq [Preprint]. 2024 May 15:rs.3.rs-4355584. doi: 10.21203/rs.3.rs-4355584/v1.
Blood, salivary samples, exhaled breath condensate (EBC), nasopharyngeal and oropharyngeal swabs.
Anna Nolan, MD
NYU Langone Health
First Submitted
January 18, 2022
First Posted
January 31, 2022
Study Start
March 22, 2023
Actual (reported)Primary Completion
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Acid Reflux and Stromal Fibroblasts in Barrett's Esophagus
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
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
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
Contact the study team to confirm eligibility.
Study Completion
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 1, 2026
Record last verified: 2026-04
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
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Source: ClinicalTrials.gov.
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