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

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ClinicalTrials.gov Identifier: NCT03858920
Recruitment Status : Enrolling by invitation
First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Andrea Branch, 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.

Condition or disease Intervention/treatment
Steatosis of Liver NASH - Nonalcoholic Steatohepatitis 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.


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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Liver in the World Trade Center Health Program General Responder Cohort and Controls
Actual Study Start Date : May 8, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 1, 2020


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 Name: 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 Name: FibroScan Test

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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Relationship between WTC exposure and liver fat [ Time Frame: Day 1 ]
    The Controlled Attenuation Parameter (CAP) scores usling 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



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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858920


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Andrea Branch, PhD Icahn School of Medicine at Mount Sinai

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Responsible Party: Andrea Branch, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03858920     History of Changes
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 )
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Liver Extracts
Hematinics