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

NASH - Nonalcoholic Steatohepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03858920
• Other study ID #: GCO 16-2612
• Secondary ID: U01OH011489-01IF
• Status: Completed
• Start date: May 8, 2018
• Est. completion date: June 11, 2021

Study information

• Verified date: July 2021
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: June 11, 2021
• Est. primary completion date: June 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• NASH - Nonalcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease
• Steatosis of Liver

Intervention

Device:
• Fibroscan of Liver
A non-invasive diagnostic device used to measure liver scarring

Procedure:
• Low-dose non-contrast CT
CT scan as part of routine research care

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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