- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03820934
FibroScan ® Study: Assessing Liver Fibrosis in Patients Using Methotrexate for Psoriasis
July 22, 2020 updated by: Neil Korman, University Hospitals Cleveland Medical Center
A Prospective, Validation Study of FibroSURE™ and FibroScan® as Screening, Detection, and Monitoring Alternatives to Liver Biopsy for Methotrexate-induced Hepatic Fibrosis and Cirrhosis in Patients With Psoriasis
The purpose of this study is to validate FibroScan and FibroSURE™ as equal or superior alternatives to liver biopsy for the monitoring and detection of methotrexate-induced hepatic fibrosis and cirrhosis in patients with moderate-to-severe psoriasis.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
The goals of this study are to validate FibroScan and FibroSURE™ as equal or superior alternatives to liver biopsy.
The goal is to evaluate the monitoring and detection of methotrexate-induced hepatic fibrosis and cirrhosis in patients with moderate-to-severe psoriasis.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ohio
-
Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female greater than or equal to 18 years of age
- Must have a diagnosis of moderate-to-severe psoriasis
- Newly starting methotrexate
Exclusion Criteria:
- Allergy to methotrexate
- History of chronic alcohol abuse
- Diagnosis of liver disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Patients undergoing Fibroscan and Fibrosure
Patient's will undergo fibroscan and fibrosure to test their liver for the level of liver fibrosis as measured by these test.
The scores from these tests will then be compared to the amount of fibrosis noted on a standard of care liver biopsy.
|
Patient's will undergo fibroscan and fibrosure to test their liver for the level of liver fibrosis as measured by these tests.
Fibroscan uses vibrations sent through the liver to measure its stiffness and the fibrosure uses laboratory and demographic parameters to create a score associated with a certain level of fibrosis.
The scores from these tests will then be compared to the amount of fibrosis noted on a standard of care liver biopsy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fibrosis Score Correlation
Time Frame: 5 years
|
The correlation between the clinical fibrosis scores generated by the FibroScan® and FibroSURE™ alone and in combination to the METAVIR fibrosis score generated from the histologic review of a liver biopsy performed for the assessment of liver fibrosis in a psoriasis patient who reaches a cumulative methotrexate dose of 1g.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fibrosis Score Validity to Liver Biopsy Results
Time Frame: 5 years
|
Determine if the clinical fibrosis scores generated by the FibroScan® and FibroSURE™ alone and in combination can be safely used as alternatives to performing a liver biopsy when screening for liver fibrosis in psoriasis patients who have reached a cumulative methotrexate dose of 1 gram
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 10, 2019
Primary Completion (Actual)
May 15, 2019
Study Completion (Actual)
May 15, 2019
Study Registration Dates
First Submitted
January 15, 2019
First Submitted That Met QC Criteria
January 28, 2019
First Posted (Actual)
January 29, 2019
Study Record Updates
Last Update Posted (Actual)
July 23, 2020
Last Update Submitted That Met QC Criteria
July 22, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-17-09
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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