Skip to main content
OpenTrials
Completed

NCT Number: NCT03858920

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Steatosis of Liver Digestive System Diseases Fatty Liver Liver Diseases NASH - Nonalcoholic Steatohepatitis Non-alcoholic Fatty Liver Disease

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fibroscan of Liver

Device

A non-invasive diagnostic device used to measure liver scarring

Other names: FibroScan Test

Low-dose non-contrast CT

Procedure

CT scan as part of routine research care

Primary outcomes

  1. FibroScan- Controlled Attenuation Parameter (CAP) scores

    Time frame: 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

  2. Attenuation Hounsfeld units signal intensity in low -dose non-contrast CT scan

    Time frame: Day 1

    The attenuation of Hounsfeld units (HU) signal intensity in low-dose non-contrast CT to estimate liver fibrosis

  3. Fibroscan

    Time frame: 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,

Secondary outcomes

  1. Relationship between WTC exposure and liver fat

    Time frame: 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.

  2. Composite score for Fibrosis and Steatosis

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 1, 2019
Registry last updated
Jul 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.