Steatosis of LiverNCT03858920
The Liver in the World Trade Center Health Program General Responder Cohort and Controls
An observational study of Steatosis of Liver and NASH - Nonalcoholic Steatohepatitis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This project investigates whether exposure to the World Trade Center Attack is a risk factor for liver injury. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Steatosis of Liver, NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- Fibroscan of Liver and Low-dose non-contrast CT
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 340 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2018to 11 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Members of the World Trade Center General Responder Cohort and individuals who are not members of this cohort.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
This project investigates whether exposure to the World Trade Center Attack is a risk factor for liver injury.
Read the 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.
- Being tested
- Fibroscan of Liver, Low-dose non-contrast CT
- Medical subject headings
- Fatty Liver, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibroscan of LiverDevice
Also called FibroScan Test
A non-invasive diagnostic device used to measure liver scarring
Low-dose non-contrast CTProcedure or surgery
CT scan as part of routine research care
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Fibroscan of Liver; Procedure: Low-dose non-contrast CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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,
Measured: Day 1
Secondary outcomes (2)
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.
Measured: Day 1
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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start8 May 2018
- Primary completion11 Jun 2021
- Study completion11 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Steatosis of LiverStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Andrea Branch, Icahn School of Medicine at Mount Sinai
- Investigators
- Andrea Branch, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858920
- Sponsor's protocol ID
- GCO 16-2612
- Other IDs
- U01OH011489-01, IF 1991038
- Status last verified
- Jul 2021
- First submitted
- 27 Feb 2018
- Last updated
- 12 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Liver in the World Trade Center Health Program General Responder Cohort and Controls
- ClinicalTrials.gov ID
- NCT03858920
- Acronym / sponsor ID
- GCO 16-2612
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 8 May 2018 (actual)
- Primary completion
- 11 Jun 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 1 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Responder Cohort (GRC) WTC Responders | – | Device: Fibroscan of Liver, Procedure: Low-dose non-contrast CTGeneral 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 |
| General Responder Cohort (GRC) Non WTC Responders | – | Device: Fibroscan of Liver, Procedure: Low-dose non-contrast CTMembers of the World Trade Center General Non Responder Cohort. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Members of the World Trade Center General Responder Cohort and individuals who are not members of this cohort.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibroscan of LiverAlso: FibroScan TestA non-invasive diagnostic device used to measure liver scarring | Device | General Responder Cohort (GRC) Non WTC Responders, General Responder Cohort (GRC) WTC Responders |
| Low-dose non-contrast CTCT scan as part of routine research care | Procedure or surgery | General Responder Cohort (GRC) Non WTC Responders, General Responder Cohort (GRC) WTC Responders |
Primary outcome
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,
2 secondary outcomes
Relationship between WTC exposure and liver fat
Time frame: Day 1
Composite score for Fibrosis and Steatosis
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Branch, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Steatosis of Liver and NASH - Nonalcoholic Steatohepatitis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FibroScan- Controlled Attenuation Parameter (CAP) scores (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021.