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NCT03531593 · ClinicalTrials.gov registry record
Dose Effect Relationship of MTX and IBD
A clinical trial, sponsored by Children's Mercy Hospital Kansas City.
- Completed
- Registry status
- 64
- Enrollment target
NCT03531593 is a clinical trial that has completed, run by Children's Mercy Hospital Kansas City. The registered enrollment target is 64 participants.
The verdict
NCT03531593 has completed, sponsored by Children's Mercy Hospital Kansas City.
- COMPLETED
- Registry status
- 64 participants
- Enrollment target
Study Summary
Currently there are no guidelines for monitoring hepatic fibrosis associated with long term MTX use. Routine liver biopsies are not being done as a part of surveillance due to potential complications like bleeding and pneumothorax. Non-invasive markers like gammaglamyltransferase (GGTP), Alkaline Phosphatase (AlkPhos), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are deranged at a late stage and may not be helpful in detecting early fibrosis. The current study will utilize a sensitive, but noninvasive, test to evaluate for hepatic fibrosis. We are attempting to screen for early detection of fibrosis due to MTX before it progresses to irreversible cirrhosis and end-stage liver disease. Based on the results of this pilot study, ultrasound elastography could be used to prospectively study a larger population to establish guidelines for monitoring safety and hepatic complications with MTX. The influence of other co-morbid factors like obesity, alcohol ingestion and smoking is critical to identifying high risk patients who may require closer monitoring. We follow close to 550 patients with IBD. If we presume that at least 20% patients are currently receiving methotrexate, we will be able to recruit enough patients for this pilot study.
Interventions
- DIAGNOSTIC_TEST Ultrasound Elastography
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2017-02-01 |
| Est. Completion | 2018-05-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03531593
The ClinicalTrials.gov registry entry for NCT03531593 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Mercy Hospital Kansas City, which has 184 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ultrasound Elastography is the first listed.
NCT03531593 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03531593 about?
NCT03531593 is a clinical study titled "Dose Effect Relationship of MTX and IBD". Currently there are no guidelines for monitoring hepatic fibrosis associated with long term MTX use. Routine liver biopsies are not being done as a part of surveillance due to potential complications like bleeding and pneumothorax. Non-invasive markers like gammaglamyltransferase (GGTP), Alkaline Ph...
What is the current status of trial NCT03531593?
This trial is currently completed. The enrollment target is 64 participants. The study started on 2017-02-01. Estimated completion is 2018-05-31.
What interventions are being tested in trial NCT03531593?
The interventions under investigation include: Ultrasound Elastography (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03531593?
This trial is sponsored by Children's Mercy Hospital Kansas City, which has 184 total clinical trials registered on ClinicalTrials.gov.
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