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)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 36-Item Short Form Survey Instrument (SF-36)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 37 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •FDNY rescue and recovery worker.
- •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/
- •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
- •19. 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.
排除标准
- •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
结局指标
主要结局
36-Item Short Form Survey Instrument (SF-36)
时间窗: up to Day 365
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.
Histamine Concentration from Exhaled Breath Condensate (EBC)
时间窗: up to Day 365
Histamine concentration will be measured with an enzymatic immunoassay
Score on Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL) Questionnaire
时间窗: up to Day 365
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.
Score on St. George's Respiratory Questionnaire (SGRQ-C)
时间窗: up to Day 365
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.
Levels of salivary pepsin
时间窗: up to Day 365
Saliva will be analyzed using the Peptest. The value of \>/= 16 ng/mL indicates a positive salivary pepsin.
pH Levels from Exhaled Breath Condensate (EBC)
时间窗: up to Day 365
EBC pH assay will be performed
Score on Patient Assessment of Upper Gastrointestinal Disorders-Symptoms (PAGI-SYM) Questionnaire
时间窗: up to Day 365
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.
次要结局
未报告次要终点