NCT05744713

Brief Summary

TARGET-Liver Disease (TARGET-LD) is an observational research study to conduct a comprehensive review of outcomes for patients with chronic liver disease (CLD).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500,000

participants targeted

Target at P75+ for all trials

Timeline
143mo left

Started Feb 2024

Longer than P75 for all trials

Geographic Reach
1 country

10 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Feb 2024Dec 2037

First Submitted

Initial submission to the registry

February 15, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
12 months until next milestone

Study Start

First participant enrolled

February 19, 2024

Completed
13.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2037

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2037

Last Updated

March 3, 2026

Status Verified

March 1, 2026

Enrollment Period

13.9 years

First QC Date

February 15, 2023

Last Update Submit

March 2, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • To characterize the natural history of disease in patients with CLD from various etiologies and Cirrhosis

    20 Years

  • To assess safety and effectiveness of CLD/Cirrhosis treatments and treatments for complications of any chronic liver disease

    20 Years

  • To establish learning health networks focused on quality of care for patients

    20 Years

Secondary Outcomes (2)

  • To evaluate provider management practices in the treatment of patients with CLD/Cirrhosis

    20 Years

  • To evaluate longitudinal and patient reported outcomes in CLD/Cirrhosis

    20 Years

Study Arms (2)

Disease Cohort

Other: Observational

Engaged Cohort

Other: Observational

Interventions

Observational

Disease CohortEngaged Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will include adults who are being managed for chronic liver disease or cirrhosis of any etiology.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Keck School of Medicine of USC

Los Angeles, California, 90033, United States

Location

Stanford Medicine

Redwood City, California, 94063, United States

Location

Georgetown Medstar Transplant Institute

Washington D.C., District of Columbia, 20007, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Columbia University Irving Medical Center/ New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Atrium Health Center for Liver Disease and Transplant

Charlotte, North Carolina, 28204, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University - Lewis Katz School of Medicine

Philadelphia, Pennsylvania, 19140, United States

Location

Baylor Scott & White Research Institute

Dallas, Texas, 75246, United States

Location

Baylor College of Medicine

Houston, Texas, 77021, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood Serum

MeSH Terms

Conditions

Fibrosis

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2023

First Posted

February 27, 2023

Study Start

February 19, 2024

Primary Completion (Estimated)

December 31, 2037

Study Completion (Estimated)

December 31, 2037

Last Updated

March 3, 2026

Record last verified: 2026-03

Locations