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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03858920
Other study ID # GCO 16-2612
Secondary ID U01OH011489-01IF
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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