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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

340 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-08

Study Completion Date

2021-06-11

Brief Summary

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

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Detailed Description

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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

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Steatosis of Liver NASH - Nonalcoholic Steatohepatitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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General Responder Cohort (GRC) WTC Responders

General Responder Cohort (GRC) and who have chosen to undergo annual medical monitoring and treatment of their WTC-related conditions at Mount Sinai's Irving J. Selikoff Center for Occupational and Environmental Medicine (SCOEM), which is directed by Dr. M. Crane

Fibroscan of Liver

Intervention Type DEVICE

A non-invasive diagnostic device used to measure liver scarring

Low-dose non-contrast CT

Intervention Type PROCEDURE

CT scan as part of routine research care

General Responder Cohort (GRC) Non WTC Responders

Members of the World Trade Center General Non Responder Cohort.

Fibroscan of Liver

Intervention Type DEVICE

A non-invasive diagnostic device used to measure liver scarring

Low-dose non-contrast CT

Intervention Type PROCEDURE

CT scan as part of routine research care

Interventions

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Fibroscan of Liver

A non-invasive diagnostic device used to measure liver scarring

Intervention Type DEVICE

Low-dose non-contrast CT

CT scan as part of routine research care

Intervention Type PROCEDURE

Other Intervention Names

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FibroScan Test

Eligibility Criteria

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Inclusion Criteria

* 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