The Liver in the World Trade Center Health Program General Responder Cohort and Controls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- FibroScan- Controlled Attenuation Parameter (CAP) scores
研究概览
简要总结
This project investigates whether exposure to the World Trade Center Attack is a risk factor for liver injury.
详细描述
This is a prospective cross-sectional study of liver disease in individuals who meet the United States Preventive Services Task Forces guidelines for lung cancer screening because they are between 55 and 80 years of age and have a 30 year pack-history of smoking and are either current smokers or who quit during the past 15 years. Liver disease will be compared between individuals who are members of the World Trade Center General Responder Cohort and individuals who are not members of this cohort. The basic objective is to determine whether exposure to the WTC attack increased liver disease.
Data will be obtained from the World Trade Center Data Center, from Mount Sinai Medical records, EPIC, the data warehouse, and from data collected by the Lung Cancer Screening Program of Dr. Henschke. Results of genetic tests that relate to liver disease will be collected from the medical record.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female between 55 and 80 years of age
- •30 year pack-history of smoking and are either current smokers or who quit during the past 15 years.
- •Individuals who are members of the World Trade Center General Responder Cohort or Subjects who meet the United States Preventive Services Task Forces guidelines for lung cancer screening
排除标准
- 未提供
结局指标
主要结局
FibroScan- Controlled Attenuation Parameter (CAP) scores
时间窗: Day 1
assesses liver fat using a patented technique called Vibration-Controlled Transient Elastography range from 0 -400 CAP with the higher number indicating great quantity of fat in the Liver CAP 240-270 S1 Mild Steatosis CAP 270-300 S2 Moderate Steatosis CAP \>300 S3 Severe Steatosis
Fibroscan
时间窗: Day 1
assesses liver stiffness using a patented technique called Vibration-Controlled Transient Elastography. Results are measured using kiloPascal's (or kPa) and range from 2 to 75kPa, with a higher number indicating more liver scarring. F0 Zero 5.3 kPa means no scarring F1 5.3-7.0 kPa is mild fibrosis F2 is 7.1-8.0 kPa moderate fibrosis F3 8.1-12.4 kPa is severe fibrosis F4 greater than 12.5 kPa is cirrhosis or advanced fibrosis,
Attenuation Hounsfeld units signal intensity in low -dose non-contrast CT scan
时间窗: Day 1
The attenuation of Hounsfeld units (HU) signal intensity in low-dose non-contrast CT to estimate liver fibrosis
次要结局
- Relationship between WTC exposure and liver fat(Day 1)
- Composite score for Fibrosis and Steatosis(Day 1)
研究者
Andrea Branch
Professor
Icahn School of Medicine at Mount Sinai