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

Completed

• Conditions: Steatosis of Liver; NASH - Nonalcoholic Steatohepatitis
• Interventions: Device: Fibroscan of Liver; Procedure: Low-dose non-contrast CT

• Registration Number: NCT03858920
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-02-27
• Study Start: 2018-05-08
• Study First Submitted QC: 2019-02-27
• Study First Posted: 2019-03-01
• Primary Completion: 2021-06-11
• Study Completion: 2021-06-11
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-09
• Last Update Posted: 2021-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
FibroScan- Controlled Attenuation Parameter (CAP) scores	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	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	Day 1	The attenuation of Hounsfeld units (HU) signal intensity in low-dose non-contrast CT to estimate liver fibrosis

Secondary Outcome Measures

Name	Time	Method
Relationship between WTC exposure and liver fat	Day 1	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.
Composite score for Fibrosis and Steatosis	Day 1	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

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States