NCT04908319 Hepatic Histopathology in Urea Cycle Disorders
| NCT ID | NCT04908319 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Baylor College of Medicine |
| Condition | Urea Cycle Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2022-02-24 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2022-02-24 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a multi-site, retrospective chart review as well as a prospective study to evaluate histopathologic findings in liver samples from individuals with any UCD diagnosis. This study will be conducted at all Urea Cycle Disorders Consortium (UCDC) sites: Baylor College of Medicine in Houston, TX and Children's National Medical Center in Washington D.C.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of primary urea cycle disorder based on clinical suspicion confirmed by enzyme activity, DNA testing or metabolite analysis. * History of liver transplantation and/or liver biopsy OR * Planned liver transplantation and/or liver biopsy Exclusion Criteria: * Unavailability of histopathology report from the liver biopsy or explant, or unavailability of liver tissue or slides from the biopsy or explant OR * Anticipated inability to obtain pathology report, liver disease, tissue blocks, or pathology slides after liver biopsy or transplantation * Known history of a secondary cause for liver disease such as chronic viral hepatitis, autoimmune liver disease, short gut, small bowel syndrome, alcohol liver disease, or TPN-related cholestatic disease
Contact & Investigator
Lindsay Burrage, MD, PhD
PRINCIPAL INVESTIGATOR
Baylor College of Medicine
Frequently Asked Questions
Who can join the NCT04908319 clinical trial?
This trial is open to participants of all sexes, studying Urea Cycle Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04908319 currently recruiting?
Yes, NCT04908319 is actively recruiting participants. Contact the research team at saima.ali@bcm.edu for enrollment information.
Where is the NCT04908319 trial being conducted?
This trial is being conducted at Washington D.C., United States, Houston, United States.
Who is sponsoring the NCT04908319 clinical trial?
NCT04908319 is sponsored by Baylor College of Medicine. The principal investigator is Lindsay Burrage, MD, PhD at Baylor College of Medicine. The trial plans to enroll 70 participants.