RECRUITING

Hepatic Histopathology in Urea Cycle Disorders

Talk to us

Conditions

Urea Cycle DisorderOrnithine Transcarbamylase DeficiencyCitrullinemia 1ARGI DeficiencyASL DeficiencyArgininosuccinic AciduriaASS DeficiencyHyperargininemiaCarbamyl Phosphate Synthetase DeficiencyNAGS DeficiencyLiver transplantLiver diseaseLiver biopsyHistopathology

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Hepatic Histopathology in Urea Cycle Disorders

Quick Facts

Study Start:2022-02-24
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04908319

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of primary urea cycle disorder based on clinical suspicion confirmed by enzyme activity, DNA testing or metabolite analysis.
  2. * History of liver transplantation and/or liver biopsy OR
  3. * Planned liver transplantation and/or liver biopsy
  1. * Unavailability of histopathology report from the liver biopsy or explant, or unavailability of liver tissue or slides from the biopsy or explant OR
  2. * Anticipated inability to obtain pathology report, liver disease, tissue blocks, or pathology slides after liver biopsy or transplantation
  3. * 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

Contacts and Locations

Study Contact

Saima Ali, MSN
CONTACT
832-822-4183
saima.ali@bcm.edu

Principal Investigator

Lindsay Burrage, MD, PhD
PRINCIPAL_INVESTIGATOR
Baylor College of Medicine

Study Locations (Sites)

Children's National Medical Center
Washington, District of Columbia, 20010
United States
Baylor College of Medicine
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

  • Lindsay Burrage, MD, PhD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-24
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2022-02-24
Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

  • Liver transplant
  • Liver disease
  • Liver biopsy
  • Histopathology

Additional Relevant MeSH Terms

  • Urea Cycle Disorder
  • Ornithine Transcarbamylase Deficiency
  • Citrullinemia 1
  • ARGI Deficiency
  • ASL Deficiency
  • Argininosuccinic Aciduria
  • ASS Deficiency
  • Hyperargininemia
  • Carbamyl Phosphate Synthetase Deficiency
  • NAGS Deficiency