By InvitationNot Applicable

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

United States200 participantsStarted 2023-03-22

Plain-language 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.

Who can participate

Age range

37 Years – 90 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Levels of salivary pepsin

Timeframe: up to Day 365

pH Levels from Exhaled Breath Condensate (EBC)

Timeframe: up to Day 365

Histamine Concentration from Exhaled Breath Condensate (EBC)

Timeframe: up to Day 365

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

Timeframe: up to Day 365

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

Timeframe: up to Day 365

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

Timeframe: up to Day 365

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

Timeframe: up to Day 365

Trial details

NCT IDNCT05216133

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-06

View on ClinicalTrials.gov More Airway Disease trials

Plain-language summary

Who can participate

Age range

37 Years – 90 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Exclusion criteria

What they're measuring

Levels of salivary pepsin

Timeframe: up to Day 365

pH Levels from Exhaled Breath Condensate (EBC)

Timeframe: up to Day 365

Histamine Concentration from Exhaled Breath Condensate (EBC)

Timeframe: up to Day 365

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

Timeframe: up to Day 365

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

Timeframe: up to Day 365

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

Timeframe: up to Day 365

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

Timeframe: up to Day 365