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

NCT05216133 | Enrolling By Invitation

• 1 other identifier: 21-00679
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Disease; Barrett Esophagus; Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (7)

• 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

  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

Eligibility Criteria

• Age: 37 Years - 90 Years
• Gender Eligibility Details: Less than 1 % of the FDNY-HP subjects are female. As such our prior work has excluded females. In addition, due to this small sample size and since there is significant literature that biomarkers are different in these two sexes, the study team will not be enrolling females.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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\*

Sponsors & Collaborators

• National Institute for Occupational Safety and Health (NIOSH/CDC): collaborator
• NYU Langone Health: lead

Study Sites (1)

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

New York, New York, 10016, United States

Location

Related Publications (2)

• 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.

  PMID: 39123126 DERIVED

• 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.

  PMID: 38798396 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, salivary samples, exhaled breath condensate (EBC), nasopharyngeal and oropharyngeal swabs.

MeSH Terms

Conditions

Barrett Esophagus; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophageal Motility Disorders; Deglutition Disorders

Study Officials

• Anna Nolan, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: January 31, 2022
• Study Start: March 22, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose will have access to the data to achieve aims in the approved proposal. Requests should be directed to anna.nolan@med.nyu.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)