Biomarkers of Airway Disease, Barrett's and Underdiagnosed Reflux Noninvasively (BADBURN) (NCT05216133) | Clinical Trial Compass
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 range37 Years – 90 Years
SexMALE
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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
✕. 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.
What they're measuring
1
Levels of salivary pepsin
Timeframe: up to Day 365
2
pH Levels from Exhaled Breath Condensate (EBC)
Timeframe: up to Day 365
3
Histamine Concentration from Exhaled Breath Condensate (EBC)
Timeframe: up to Day 365
4
Score on Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL) Questionnaire
Timeframe: up to Day 365
5
Score on Patient Assessment of Upper Gastrointestinal Disorders-Symptoms (PAGI-SYM) Questionnaire
Timeframe: up to Day 365
6
Score on St. George's Respiratory Questionnaire (SGRQ-C)
✕. 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.