NCT03858920

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 8, 2018

Completed
10 months until next milestone

First Posted

Study publicly available on registry

March 1, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2021

Completed
Last Updated

July 12, 2021

Status Verified

July 1, 2021

Enrollment Period

3.1 years

First QC Date

February 27, 2018

Last Update Submit

July 9, 2021

Conditions

Steatosis of LiverNASH - Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (2)

  • Relationship between WTC exposure and liver fat

    Day 1

  • Composite score for Fibrosis and Steatosis

    Day 1

Study Arms (2)

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 LiverProcedure: Low-dose non-contrast CT

General Responder Cohort (GRC) Non WTC Responders

Members of the World Trade Center General Non Responder Cohort.

Device: Fibroscan of LiverProcedure: Low-dose non-contrast CT

Interventions

Fibroscan of LiverDEVICE

A non-invasive diagnostic device used to measure liver scarring

Also known as: FibroScan Test
General Responder Cohort (GRC) Non WTC RespondersGeneral Responder Cohort (GRC) WTC Responders
Low-dose non-contrast CTPROCEDURE

CT scan as part of routine research care

General Responder Cohort (GRC) Non WTC RespondersGeneral Responder Cohort (GRC) WTC Responders

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Members of the World Trade Center General Responder Cohort and individuals who are not members of this cohort.

You may qualify if:

  • Male or Female between 55 and 80 years of age
  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Fatty LiverNon-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Andrea Branch, PhD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 27, 2018

First Posted

March 1, 2019

Study Start

May 8, 2018

Primary Completion

June 11, 2021

Study Completion

June 11, 2021

Last Updated

July 12, 2021

Record last verified: 2021-07

Locations

US(1)