Biomarkers of Airway Disease, Barrett's and Underdiagnosed Reflux Noninvasively (BADBURN)
A legfontosabb adatok
- Hol
- New York (Egyesült Államok)A helyszín megnézése
Neked szólhat?
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 37 és 90 év között vagy?
Forrás: NCT05216133: ki vehet részt
Helyszínek itt: Egyesült Államok
- NYU Clinical & Translational Science Institute Clinical Research Center (CTSI CRC)New York, Egyesült ÁllamokNo longer taking part
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Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- NYU Langone Health
- Azonosító
- NCT05216133
- A regiszteradat frissítve
- 2026. május 1.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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.
Bevonási feltételek: 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; 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; 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.
Kizáró feltételek: 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; 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; Unwilling to complete an informed consent; Not enrolled in the WTC-HP; Life-expectancy < 6 months; Female*.