A Longitudinal Observational Study of the Natural History and Management of Patients With HCC
1 other identifier
observational
10,000
5 countries
71
Brief Summary
TARGET-HCC is a longitudinal, observational study of patients being managed for HCC in usual clinical practice. TARGET-HCC will create a research registry of participants with HCC within academic and community real-world practices in order to assess the safety and effectiveness of the entire spectrum of current and future therapies across diverse populations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2016
Longer than P75 for all trials
71 active sites
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
First Submitted
Initial submission to the registry
November 1, 2016
CompletedFirst Posted
Study publicly available on registry
November 3, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
April 17, 2026
April 1, 2026
10.2 years
November 1, 2016
April 14, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Establish a longitudinal observational cohort to understand the natural history and management of HCC, including the safety and outcomes of HCC treatment interventions utilized in usual clinical practice
Up to 15 years
Secondary Outcomes (3)
Evaluate the impact of HCC treatment interventions and concomitant medications on comorbid conditions and liver function
Up to 15 years
Evaluate patient-reported outcomes measures during the natural course of HCC and management with HRQoL questionnaires
Up to 15 years
Establish a Biorepository Specimen Bank (BSB)
Up to 15 years
Eligibility Criteria
Adult patients being managed for HCC
You may qualify if:
- Male or female patients, age ≥18 years
- Patients with a histological/cytological or radiological diagnosis of HCC (mixed HCC cholangiocarcinoma may be included; patients who are candidates for surgical and non-surgical treatment, as well as those being followed without specific HCC therapy may be included)
You may not qualify if:
- \. Inability to provide written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (71)
Banner University Medical Center
Phoenix, Arizona, 85006, United States
University of Arkansas
Little Rock, Arkansas, 72205, United States
University of Southern California/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Stanford University
Palo Alto, California, 94304, United States
California Liver Research Institute
Pasadena, California, 91105, United States
University of California-Davis
Sacramento, California, 95817, United States
University of California
San Francisco, California, 94158, United States
Georgetown University
Washington D.C., District of Columbia, 20007, United States
Gastro Florida
Clearwater, Florida, 33762, United States
University of Florida Hepatology Research at CTRB
Gainesville, Florida, 32610-0272, United States
University of Florida Health Gastroenterology
Jacksonville, Florida, 32207, United States
Schiff Center for Liver Diseases/University of Miami
Miami, Florida, 33136, United States
Tampa General Medical Group
Tampa, Florida, 33606, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309, United States
Piedmont Cancer Institute
Atlanta, Georgia, 30318, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Northwestern University Division of Gastroenterology and Hepatology
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Tulane University
New Orleans, Louisiana, 70112, United States
Mercy Medical Center, GI Research
Baltimore, Maryland, 21202, United States
Johns Hopkins University
Baltimore, Maryland, 21205, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Southern Therapy and Advanced Research (STAR) LLC
Jackson, Mississippi, 39216, United States
Saint Louis University
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68106, United States
Rutgers-Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901, United States
Northwell Health - Center for Liver Diseases
Manhasset, New York, 11030, United States
NYU Langone Health
New York, New York, 10016, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Columbia University
New York, New York, 10032, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Center for Liver Disease and Transplant at CMC
Charlotte, North Carolina, 28204, United States
Providence Health & Services Cancer Clinical Trials
Portland, Oregon, 97213, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina
Charleston, South Carolina, 29403, United States
Vanderbilt University Medical Center - GI Research Office
Nashville, Tennessee, 37212, United States
Clinical Research Institute@ Methodist Dallas Medical Center
Dallas, Texas, 75203, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-8887, United States
Baylor Scott & White All Saints
Fort Worth, Texas, 76104, United States
Research Specialists of Texas
Houston, Texas, 77030, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Bon Secours Liver Institute of Virginia
Richmond, Virginia, 23226, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Wenatchee Valley Hospital & Clinics
Wenatchee, Washington, 98801, United States
University of Wisconsin
Madison, Wisconsin, 53705-2281, United States
CHU de Nice - Hôpital L'Archet 2
Nice, France
Hôpitaux Universitaires Paris Centre
Paris, France
Universitätsklinikum Aachen
Aachen, Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Universitätsklinikum Frankfurt
Frankfurt, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
Universitätsklinikum Magdeburg
Magdeburg, Germany
Universitätsmedizin Mainz
Mainz, Germany
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
A.O.U.P. di Palermo
Palermo, Italy
Humanitas Mirasole IRCCS
Rozzano, Italy
IRCCS "Casa Sollievo della Sofferenza"
San Giovanni Rotondo, Italy
Hospital Puerta de Hierro Majadahonda
Madrid, Spain
Clínica Universidad de Navarra
Pamplona, Spain
Hospital Universitario Marques de Valdecilla
Santander, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Hospital Universitario Politècnic La Fe
Valencia, Spain
Related Publications (1)
Cabrera R, Singal AG, Colombo M, Kelley RK, Lee H, Mospan AR, Meyer T, Newell P, Parikh ND, Sangro B, Reddy KR, Watkins S, Zink RC, Di Bisceglie AM. A Real-World Observational Cohort of Patients with Hepatocellular Carcinoma: Design and Rationale for TARGET-HCC. Hepatol Commun. 2020 Dec 21;5(3):538-547. doi: 10.1002/hep4.1652. eCollection 2021 Mar.
PMID: 33681685DERIVED
Biospecimen
Patients enrolled in TARGET-HCC may be invited to participate in the Biorepository Specimen Bank (BSB). Blood samples and tissue samples for biomarker and DNA assays will be collected on a voluntary basis and participation in this project will not affect participation in the main study. These samples will be shipped to a central repository for storage to use in future studies. Samples stored at the biorepository will be identified only with the participant's unique study ID number and the date that the sample was obtained. This link between the participant's study ID number and their name will be available only at the site where the samples were obtained.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 15 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2016
First Posted
November 3, 2016
Study Start
December 1, 2016
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share