Enrolling by invitation NCT05744713
An Observational Study of Patients With Chronic Liver Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observational.
- Who it may be relevant to
- Registry conditions: Chronic Liver Disease, Cirrhosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
TARGET-Liver Disease (TARGET-LD) is an observational research study to conduct a comprehensive review of outcomes for patients with chronic liver disease (CLD).
Interventions
- Other Observational
Observational
Primary outcome measures
- To characterize the natural history of disease in patients with CLD from various etiologies and Cirrhosis [Time frame: 20 Years]
- To assess safety and effectiveness of CLD/Cirrhosis treatments and treatments for complications of any chronic liver disease [Time frame: 20 Years]
- To establish learning health networks focused on quality of care for patients [Time frame: 20 Years]
Secondary outcome measures (2)
- To evaluate provider management practices in the treatment of patients with CLD/Cirrhosis [Time frame: 20 Years]
- To evaluate longitudinal and patient reported outcomes in CLD/Cirrhosis [Time frame: 20 Years]
Eligibility criteria
Inclusion criteria
Disease Cohort
•Adult\* patients at the time of enrollment with a diagnosis of CLD/cirrhosis by ICD-10 code in the EHR interface
Engaged Cohort
- Adult\* patients diagnosed and managed for CLD/cirrhosis invited to participate
- Ability to provide written informed consent
Exclusion criteria
Disease Cohort
- Death
- Manual removal (sponsor or site request)
- No EHR interface encounter > 3 years.
Engaged Cohort
- Patient expressed desire to withdraw consent to complete PROs
- Failure to complete PROs within 24 weeks of initial invitation
- Greater than 24 months lapse of survey completion after baseline surveys completed
- Additionally, the criteria detailed for Disease Cohort apply to the Engaged Cohort.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 10 centers
- Keck School of Medicine of USC — Los Angeles
- Stanford Medicine — Redwood City
- Georgetown Medstar Transplant Institute — Washington D.C.
- Rush University Medical Center — Chicago
- Columbia University Irving Medical Center/ New York Presbyterian Hospital — New York
- Atrium Health Center for Liver Disease and Transplant — Charlotte
- University of Pennsylvania — Philadelphia
- Temple University - Lewis Katz School of Medicine — Philadelphia
- … and 2 more centers
Identifiers
NCT: NCT05744713 · TARGET-LD