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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: Completed study, sponsored by Children's Mercy Hospital Kansas City.
NCT03531593 is a clinical trial that has completed, run by Children's Mercy Hospital Kansas City. The registered enrollment target is 64 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To evaluate the correlation between velocities of shear wave elastography and cumulative dose of Methotrexate (MTX) in patients with Inflammatory Bowel Disease (IBD).
Interventions
- DIAGNOSTIC_TEST Ultrasound Elastography
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2017-02-01 |
| Est. Completion | 2018-05-31 |
What the finished NCT03531593 record still lists
NCT03531593 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 64 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Ultrasound Elastography is the first listed.
NCT03531593 does not publish any study locations in the registry export this page uses.
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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