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FibroScan ® Study: Assessing Liver Fibrosis in Patients Using Methotrexate for Psoriasis

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ClinicalTrials.gov Identifier: NCT03820934
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Neil Korman, University Hospitals Cleveland Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Psoriasis Diagnostic Test: Fibroscan and Fibrosure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: 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
Estimated Study Start Date : February 10, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Psoriasis

Arm Intervention/treatment
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.
Diagnostic Test: Fibroscan and Fibrosure
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03820934


Contacts
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Contact: Kory Schrom, MD 216-844-5728 Kory.Schrom@UHhospitals.org
Contact: Amanda Davies 216-844-7834 Amanda.Davies@UHhospitals.org

Locations
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United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Kory Schrom, MD    216-844-5728    Kory.Schrom@UHhospitals.org   
Contact: Amanda Davies    216-844-7834    Amanda.Davies@UHhospitals.org   
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Investigators
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Principal Investigator: Neil Korman, MD University Hospitals Cleveland Medical Center

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Responsible Party: Neil Korman, Director, Clinical Trials Unit, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT03820934     History of Changes
Other Study ID Numbers: 12-17-09
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Neil Korman, University Hospitals Cleveland Medical Center:
Methotrexate
FibroScan
FibroSure
Cirrhosis
Fibrosis

Additional relevant MeSH terms:
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Psoriasis
Fibrosis
Pathologic Processes
Skin Diseases, Papulosquamous
Skin Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors