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

• ClinicalTrials.gov Identifier: NCT03858920
• Recruitment Status: Enrolling by invitation
• First Posted: March 1, 2019
• Last Update Posted: November 12, 2020
• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborator: National Institutes of Health (NIH)
• Information provided by (Responsible Party): Andrea Branch, Icahn School of Medicine at Mount Sinai

Tracking Information

• First Submitted Date: February 27, 2018
• First Posted Date: March 1, 2019
• Last Update Posted Date: November 12, 2020
• Actual Study Start Date: May 8, 2018
• Estimated Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 27, 2019)

• 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
• 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
• 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,

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 1, 2020)

• 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.
• 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

Original Secondary Outcome Measures (submitted: February 27, 2019)

• 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.
• 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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Liver in the World Trade Center Health Program General Responder Cohort and Controls
• Official Title: The Liver in the World Trade Center Health Program General Responder Cohort and Controls
• Brief Summary: This project investigates whether exposure to the World Trade Center Attack is a risk factor for liver injury.

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.

• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Steatosis of Liver
• NASH - Nonalcoholic Steatohepatitis

Intervention

• 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

Study Groups/Cohorts

• 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
  Interventions:

  • Device: Fibroscan of Liver
  • Procedure: Low-dose non-contrast CT
• General Responder Cohort (GRC) Non WTC Responders
  Members of the World Trade Center General Non Responder Cohort.
  Interventions:

  • Device: Fibroscan of Liver
  • Procedure: Low-dose non-contrast CT

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: February 27, 2019): 400
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2021
• Estimated Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 55 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03858920
• 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 )
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Andrea Branch, Icahn School of Medicine at Mount Sinai
• Study Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Institutes of Health (NIH)

Investigators

• Principal Investigator: Andrea Branch, PhD; Icahn School of Medicine at Mount Sinai

• PRS Account: Icahn School of Medicine at Mount Sinai
• Verification Date: November 2020