- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02954094
A Longitudinal Observational Study of the Natural History and Management of Patients With HCC
April 14, 2026 updated by: Target PharmaSolutions, Inc.
A Longitudinal Observational Study of the Natural History and Management of Patients With Hepatocellular Carcinoma
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.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
10000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nice, France
- CHU de Nice - Hôpital L'Archet 2
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Paris, France
- Hôpitaux Universitaires Paris Centre
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Aachen, Germany
- Universitätsklinikum Aachen
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Berlin, Germany
- Charité - Universitätsmedizin Berlin
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Düsseldorf, Germany
- Universitätsklinikum Düsseldorf
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Frankfurt, Germany
- Universitätsklinikum Frankfurt
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Hanover, Germany
- Medizinische Hochschule Hannover
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Leipzig, Germany
- Universitatsklinikum Leipzig
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Magdeburg, Germany
- Universitätsklinikum Magdeburg
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Mainz, Germany
- Universitätsmedizin Mainz
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Milan, Italy
- Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
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Palermo, Italy
- A.O.U.P. di Palermo
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Rozzano, Italy
- Humanitas Mirasole IRCCS
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San Giovanni Rotondo, Italy
- IRCCS "Casa Sollievo della Sofferenza"
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Madrid, Spain
- Hospital Puerta de Hierro Majadahonda
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Pamplona, Spain
- Clinica Universidad de Navarra
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Santander, Spain
- Hospital Universitario Marqués de Valdecilla
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Seville, Spain
- Hospital Universitario Virgen del Rocio
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Valencia, Spain
- Hospital Universitario Politècnic La Fe
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Arizona
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Phoenix, Arizona, United States, 85006
- Banner University Medical Center
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas
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California
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Los Angeles, California, United States, 90033
- University of Southern California/Norris Comprehensive Cancer Center
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Palo Alto, California, United States, 94304
- Stanford University
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Pasadena, California, United States, 91105
- California Liver Research Institute
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Sacramento, California, United States, 95817
- University of California-Davis
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San Francisco, California, United States, 94158
- University of California
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District of Columbia
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Washington D.C., District of Columbia, United States, 20007
- Georgetown University
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Florida
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Clearwater, Florida, United States, 33762
- Gastro Florida
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Gainesville, Florida, United States, 32610-0272
- University of Florida Hepatology Research at CTRB
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Jacksonville, Florida, United States, 32207
- University of Florida Health Gastroenterology
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Miami, Florida, United States, 33136
- Schiff Center for liver Diseases/University of Miami
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Tampa, Florida, United States, 33606
- Tampa General Medical Group
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital
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Atlanta, Georgia, United States, 30318
- Piedmont Cancer Institute
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Atlanta, Georgia, United States, 30309
- Piedmont Atlanta Hospital
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Illinois
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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Chicago, Illinois, United States, 60637
- University of Chicago
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Chicago, Illinois, United States, 60611
- Northwestern University Division of Gastroenterology and Hepatology
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa Hospitals and Clinics
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Tulane University
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Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins University
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Baltimore, Maryland, United States, 21202
- Mercy Medical Center, GI Research
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Health System
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Mississippi
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Jackson, Mississippi, United States, 39216
- Southern Therapy and Advanced Research (STAR) LLC
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Missouri
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St Louis, Missouri, United States, 63110
- Saint Louis University
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Nebraska
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Omaha, Nebraska, United States, 68106
- University of Nebraska Medical Center
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New Jersey
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New Brunswick, New Jersey, United States, 08901
- Rutgers-Robert Wood Johnson Medical School
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New York
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Manhasset, New York, United States, 11030
- Northwell Health - Center for Liver Diseases
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New York, New York, United States, 10032
- Columbia University
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New York, New York, United States, 10016
- NYU Langone Health
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New York, New York, United States, 10021
- Weill Cornell Medical College
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill
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Charlotte, North Carolina, United States, 28204
- Center for Liver Disease and Transplant at CMC
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Oregon
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Portland, Oregon, United States, 97213
- Providence Health & Services Cancer Clinical Trials
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Penn State Hershey Medical Center
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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South Carolina
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Charleston, South Carolina, United States, 29403
- Medical University of South Carolina
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Tennessee
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Nashville, Tennessee, United States, 37212
- Vanderbilt University Medical Center - GI Research Office
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Texas
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Dallas, Texas, United States, 75203
- Clinical Research Institute@ Methodist Dallas Medical Center
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Dallas, Texas, United States, 75390-8887
- University of Texas Southwestern Medical Center
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Fort Worth, Texas, United States, 76104
- Baylor Scott & White All Saints
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Houston, Texas, United States, 77030
- Research Specialists of Texas
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia
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Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
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Richmond, Virginia, United States, 23226
- Bon Secours Liver Institute of Virginia
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Washington
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Seattle, Washington, United States, 98104
- Harborview Medical Center
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Wenatchee, Washington, United States, 98801
- Wenatchee Valley Hospital & Clinics
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Wisconsin
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Madison, Wisconsin, United States, 53705-2281
- University of Wisconsin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult patients being managed for HCC
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
1. Inability to provide written informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
Time Frame: Up to 15 years
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Up to 15 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Evaluate the impact of HCC treatment interventions and concomitant medications on comorbid conditions and liver function
Time Frame: Up to 15 years
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Up to 15 years
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Evaluate patient-reported outcomes measures during the natural course of HCC and management with HRQoL questionnaires
Time Frame: Up to 15 years
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Up to 15 years
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Establish a Biorepository Specimen Bank (BSB)
Time Frame: Up to 15 years
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Up to 15 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2016
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Study Registration Dates
First Submitted
November 1, 2016
First Submitted That Met QC Criteria
November 1, 2016
First Posted (Estimated)
November 3, 2016
Study Record Updates
Last Update Posted (Actual)
April 17, 2026
Last Update Submitted That Met QC Criteria
April 14, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TARGET-HCC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Zhongshan People's Hospital, Guangdong, ChinaRecruiting
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Shen LinMETiS PharmaceuticalsRecruitingHepatocellular Carcinoma (HCC) | Liver Cancer, Adult | HCC - Hepatocellular Carcinoma | Metastatic Liver CancersChina
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Daiichi Sankyo, Inc.TerminatedAdvanced Solid Tumors | Hepatocellular Cancer (HCC)United Kingdom