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Airway DiseaseNCT05216133

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

An observational study of Airway Disease and Barrett Esophagus, run by NYU Langone Health at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 37 to 90 years, men only
How many people
200 participants
Where
1 siteUnited States
Study dates
22 Mar 2023to Jul 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 37 to 90 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: Male FDNY rescue and recovery workers between the ages of 37 and 90.

Who may be able to join

  • 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
Show all 25Show fewer
  • 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
  • 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.

Who cannot join

  • 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*

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

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

    New York, New York, 10016

Other trials in United States

About this study

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)

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.

Medical subject headings
Barrett Esophagus, Gastroesophageal Reflux

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Levels of salivary pepsin

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

    Measured: up to Day 365

  2. pH Levels from Exhaled Breath Condensate (EBC)

    EBC pH assay will be performed

    Measured: up to Day 365

  3. Histamine Concentration from Exhaled Breath Condensate (EBC)

    Histamine concentration will be measured with an enzymatic immunoassay

    Measured: up to Day 365

  4. 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.

    Measured: up to Day 365

  5. 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.

    Measured: up to Day 365

  6. 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.

    Measured: up to Day 365

  7. 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.

    Measured: up to Day 365

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2022
  2. Study start22 Mar 2023
  3. Primary completionJun 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05216133
Sponsor's protocol ID
21-00679
Status last verified
Apr 2026
First submitted
18 Jan 2022
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.

Publications

  • 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.

    PubMed 39123126

  • 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.

    PubMed 38798396

Questions about this trial

What is this clinical trial studying?

An observational study of Airway Disease and Barrett Esophagus, run by NYU Langone Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Levels of salivary pepsin (time frame: up to Day 365). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05216133, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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