FibroScan ® Study: Assessing Liver Fibrosis in Patients Using Methotrexate for Psoriasis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03820934|
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Diagnostic Test: Fibroscan and Fibrosure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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
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
|Contact: Kory Schrom, MD||216-844-5728||Kory.Schrom@UHhospitals.org|
|Contact: Amanda Davies||216-844-7834||Amanda.Davies@UHhospitals.org|
|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|
|Principal Investigator:||Neil Korman, MD||University Hospitals Cleveland Medical Center|