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.
Study Type
OBSERVATIONAL
Enrollment
200
NYU Clinical & Translational Science Institute Clinical Research Center (CTSI CRC)
New York, New York, United States
Levels of salivary pepsin
Saliva will be analyzed using the Peptest. The value of \>/= 16 ng/mL indicates a positive salivary pepsin.
Time frame: up to Day 365
pH Levels from Exhaled Breath Condensate (EBC)
EBC pH assay will be performed
Time frame: up to Day 365
Histamine Concentration from Exhaled Breath Condensate (EBC)
Histamine concentration will be measured with an enzymatic immunoassay
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: up to Day 365
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