RecruitingNCT05750498

A-LiNK: Improving Outcomes in Autoimmune Liver Disease

Autoimmune Liver Disease Network for Kids (A-LiNK): Using Patient Data to Transform Care and Improve Outcomes for Children, Adolescents, and Young Adults With Autoimmune Liver Disease


Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

800 participants

Start Date

Apr 28, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

The Autoimmune Liver disease Network for Kids (A-LiNK) is a multi-institutional group with the mission to deliver the best care to kids with pediatric autoimmune liver disease (AILD). This study will establish a shared clinical registry and a learning health network for the participating sites focusing on collecting and transmitting clinical measurement data, information about processes, and participation in an improvement collaborative. Pediatric Autoimmune Hepatitis (AIH) and Primary Sclerosing Cholangitis (PSC), represent a spectrum of AILD which present unique diagnostic and therapeutic challenges.A lack of accepted guidelines for disease monitoring or symptom management results in wide treatment variation with liver transplants indicated in refractory, progressive disease. The aims of A-LiNK are to: 1.) Create a learning health network focused on patient-centered outcomes research characterized by transparent sharing among centers, common priorities, and feasible plans for implementing new practices; 2) shift from traditional investigator-driven study to a patient and family-centered approach, and 3.) improve clinical outcomes and quality of life for pediatric AILD patients.


Eligibility

Plain Language Summary

Simplified for easier understanding

The A-LiNK study is creating a clinical registry for patients with autoimmune liver diseases — specifically autoimmune hepatitis (AIH), primary sclerosing cholangitis (PSC), and autoimmune sclerosing cholangitis (ASC). These are uncommon conditions where the immune system attacks the liver or bile ducts, causing progressive inflammation and scarring. By tracking large numbers of patients over time, researchers hope to better understand how these diseases behave, identify predictors of disease progression, and improve treatment decision-making. To participate, you must have a confirmed clinical diagnosis of one of these three autoimmune liver conditions (AIH, PSC, or ASC). There are no age restrictions mentioned, making this broadly inclusive. People who have previously had a liver transplant are excluded from participation. Participants will contribute clinical and outcomes data to the registry over time. This kind of real-world observational registry is invaluable in rare diseases like autoimmune liver conditions, where individual centers see too few patients to draw reliable conclusions on their own. Pooling data across multiple centers enables researchers to identify patterns, develop better prognostic tools, and design more targeted clinical trials for patients with these challenging conditions.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNo interventions

There are no interventions


Locations(8)

Stanford University

Palo Alto, California, United States

Riley Children's Health

Indianapolis, Indiana, United States

St. Louis Children's Hospital

St Louis, Missouri, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Seattle Children's Hospital

Seattle, Washington, United States

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NCT05750498


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