Actively Recruiting

All Genders
NCT04908319

Hepatic Histopathology in Urea Cycle Disorders

Led by Baylor College of Medicine · Updated on 2025-07-20

70

Participants Needed

2

Research Sites

226 weeks

Total Duration

On this page

Sponsors

B

Baylor College of Medicine

Lead Sponsor

C

Children's National Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Hepatic Histopathology in Urea Cycle Disorders

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of primary urea cycle disorder 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
Not Eligible

You will not qualify if you...

  • No available histopathology report or liver tissue/slides from biopsy or explant
  • Expected inability to obtain pathology report, liver tissue blocks, or pathology slides after liver biopsy or transplantation
  • Known secondary liver diseases such as chronic viral hepatitis, autoimmune liver disease, short gut, small bowel syndrome, alcohol liver disease, or TPN-related cholestatic disease

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Children's National Medical Center

Washington D.C., District of Columbia, United States, 20010

Not Yet Recruiting

2

Baylor College of Medicine

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

S

Saima Ali, MSN

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Hepatic Histopathology in Urea Cycle Disorders | DecenTrialz