Clinical trial NCT05744713: An Observational Study of Patients With Chronic Liver Disease
Official title: An Observational Study of Patients With Chronic Liver Disease
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Chronic Liver Disease
Cirrhosis
Lead sponsor: Target PharmaSolutions, Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-27
Enrollment: 500000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include adults who are being managed for chronic liver disease or cirrhosis of any etiology.

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).


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.

Primary outcomes:
measure: To characterize the natural history of disease in patients with CLD from various etiologies and Cirrhosis
timeFrame: 20 Years
measure: To assess safety and effectiveness of CLD/Cirrhosis treatments and treatments for complications of any chronic liver disease
timeFrame: 20 Years
measure: To establish learning health networks focused on quality of care for patients
timeFrame: 20 Years
Secondary outcomes:
measure: To evaluate provider management practices in the treatment of patients with CLD/Cirrhosis
timeFrame: 20 Years
measure: To evaluate longitudinal and patient reported outcomes in CLD/Cirrhosis
timeFrame: 20 Years
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Medicine
state: California
city: Washington
country: United States
facility: Georgetown Medstar Transplant Institute
state: District of Columbia
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center/ New York Presbyterian Hospital
state: New York
city: Charlotte
country: United States
facility: Atrium Health Center for Liver Disease and Transplant
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References: