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

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Mount Sinai Health System

Status

Completed

Conditions

Steatosis of Liver
NASH - Nonalcoholic Steatohepatitis

Treatments

Procedure: Low-dose non-contrast CT
Device: Fibroscan of Liver

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT03858920
GCO 16-2612
U01OH011489-01 (U.S. NIH Grant/Contract)
IF 1991038 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

340 patients

Sex

All

Ages

55 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Exclusion criteria

None

Trial design

340 participants in 2 patient groups

General Responder Cohort (GRC) WTC Responders
Description:
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
Treatment:
Device: Fibroscan of Liver
Procedure: Low-dose non-contrast CT
General Responder Cohort (GRC) Non WTC Responders
Description:
Members of the World Trade Center General Non Responder Cohort.
Treatment:
Device: Fibroscan of Liver
Procedure: Low-dose non-contrast CT

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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