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

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

Study Overview

• Status: Completed
• Conditions: NASH - Nonalcoholic Steatohepatitis; Steatosis of Liver
• Intervention / Treatment: Device: Fibroscan of Liver; Procedure: Low-dose non-contrast CT

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.

• Study Type: Observational
• Enrollment (Actual): 340

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Members of the World Trade Center General Responder Cohort and individuals who are not members of this cohort.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Device: Fibroscan of Liver; A non-invasive diagnostic device used to measure liver scarring; Other Names: FibroScan Test; Procedure: Low-dose non-contrast CT; 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.	Device: Fibroscan of Liver; A non-invasive diagnostic device used to measure liver scarring; Other Names: FibroScan Test; Procedure: Low-dose non-contrast CT; CT scan as part of routine research care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FibroScan- Controlled Attenuation Parameter (CAP) scores	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	Day 1
Attenuation Hounsfeld units signal intensity in low -dose non-contrast CT scan	The attenuation of Hounsfeld units (HU) signal intensity in low-dose non-contrast CT to estimate liver fibrosis	Day 1
Fibroscan	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,	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between WTC exposure and liver fat	The Controlled Attenuation Parameter (CAP) scores using a Multiple linear regression modeling to determine whether WTC exposure is significantly associated with liver fat content after adjusting for potential confounding factors ,smoking history, diabetes and BMI.	Day 1
Composite score for Fibrosis and Steatosis	Composite score from Fibroscan to compare for exposure to WTC site Clinically significant fibrosis will be defined as Fibroscan >8.0kPa and Steatosis will be defined as a Fibroscan CAP >300dB/m indicating advance steatosis <7.9 kPa score Zero , >8.0 kPa score 1, <299 CAP will score Zero, >300 CAP will score 1 Range of total score Zero -2 equals best to worst scoring	Day 1

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Andrea Branch, PhD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2018
• Primary Completion (Actual): June 11, 2021
• Study Completion (Actual): June 11, 2021

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: February 27, 2019
• First Posted (Actual): March 1, 2019

Study Record Updates

• Last Update Posted (Actual): July 12, 2021
• Last Update Submitted That Met QC Criteria: July 9, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: GCO 16-2612; U01OH011489-01 (U.S. NIH Grant/Contract); IF 1991038 (Other Identifier: Icahn School of Medicine at Mount Sinai)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes