NCT03858920

The Liver in the World Trade Center Health Program General Responder Cohort and Controls

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 340 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 55 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This project investigates whether exposure to the World Trade Center Attack is a risk factor for liver injury.

Detailed description

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.

Conditions

• Steatosis of Liver
• NASH - Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DEVICE	Fibroscan of Liver	A non-invasive diagnostic device used to measure liver scarring
PROCEDURE	Low-dose non-contrast CT	CT scan as part of routine research care

Timeline

• Start date: 2018-05-08
• Primary completion: 2021-06-11
• Completion: 2021-06-11
• First posted: 2019-03-01
• Last updated: 2021-07-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study