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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Nice, France
        • CHU de Nice - Hôpital L'Archet 2
      • Paris, France
        • Hôpitaux Universitaires Paris Centre
  • Germany
      • Aachen, Germany
        • Universitätsklinikum Aachen
      • Berlin, Germany
        • Charité - Universitätsmedizin Berlin
      • Düsseldorf, Germany
        • Universitätsklinikum Düsseldorf
      • Frankfurt, Germany
        • Universitätsklinikum Frankfurt
      • Hanover, Germany
        • Medizinische Hochschule Hannover
      • Leipzig, Germany
        • Universitatsklinikum Leipzig
      • Magdeburg, Germany
        • Universitätsklinikum Magdeburg
      • Mainz, Germany
        • Universitatsmedizin Mainz
  • Italy
      • Milan, Italy
        • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
      • Palermo, Italy
        • A.O.U.P. di Palermo
      • Rozzano, Italy
        • Humanitas Mirasole IRCCS
      • San Giovanni Rotondo, Italy
        • IRCCS "Casa Sollievo della Sofferenza"
  • Spain
      • Madrid, Spain
        • Hospital Puerta de Hierro Majadahonda
      • Pamplona, Spain
        • Clinica Universidad de Navarra
      • Santander, Spain
        • Hospital Universitario Marqués de Valdecilla
      • Seville, Spain
        • Hospital Universitario Virgen del Rocío
      • Valencia, Spain
        • Hospital Universitario Politècnic La Fe
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner University Medical Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California/Norris Comprehensive Cancer Center
      • Palo Alto, California, United States, 94304
        • Stanford University
      • Pasadena, California, United States, 91105
        • California Liver Research Institute
      • Sacramento, California, United States, 95817
        • University of California-Davis
      • San Francisco, California, United States, 94158
        • University of California
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Georgetown University
    • Florida
      • Clearwater, Florida, United States, 33762
        • Gastro Florida
      • Gainesville, Florida, United States, 32610-0272
        • University of Florida Hepatology Research at CTRB
      • Jacksonville, Florida, United States, 32207
        • University of Florida Health Gastroenterology
      • Miami, Florida, United States, 33136
        • Schiff Center for Liver Diseases/University of Miami
      • Tampa, Florida, United States, 33606
        • Tampa General Medical Group
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30318
        • Piedmont Cancer Institute
      • Atlanta, Georgia, United States, 30309
        • Piedmont Atlanta Hospital
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Chicago, Illinois, United States, 60611
        • Northwestern University Division of Gastroenterology and Hepatology
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Center, GI Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Southern Therapy and Advanced Research (STAR) LLC
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Saint Louis University
    • Nebraska
      • Omaha, Nebraska, United States, 68106
        • University of Nebraska Medical Center
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers-Robert Wood Johnson Medical School
    • New York
      • Manhasset, New York, United States, 11030
        • Northwell Health - Center for Liver Diseases
      • New York, New York, United States, 10032
        • Columbia University
      • New York, New York, United States, 10016
        • NYU Langone Health
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
      • Charlotte, North Carolina, United States, 28204
        • Center for Liver Disease and Transplant at CMC
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Health & Services Cancer Clinical Trials
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center - GI Research Office
    • Texas
      • Dallas, Texas, United States, 75203
        • Clinical Research Institute@ Methodist Dallas Medical Center
      • Dallas, Texas, United States, 75390-8887
        • University of Texas Southwestern Medical Center
      • Fort Worth, Texas, United States, 76104
        • Baylor Scott & White All Saints
      • Houston, Texas, United States, 77030
        • Research Specialists of Texas
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
      • Richmond, Virginia, United States, 23226
        • Bon Secours Liver Institute of Virginia
    • Washington
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center
      • Wenatchee, Washington, United States, 98801
        • Wenatchee Valley Hospital & Clinics
    • Wisconsin
      • Madison, Wisconsin, United States, 53705-2281
        • University of Wisconsin

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  1. Male or female patients, age ≥18 years
  2. 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Up to 15 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Evaluate the impact of HCC treatment interventions and concomitant medications on comorbid conditions and liver function
Time Frame: Up to 15 years
Up to 15 years
Evaluate patient-reported outcomes measures during the natural course of HCC and management with HRQoL questionnaires
Time Frame: Up to 15 years
Up to 15 years
Establish a Biorepository Specimen Bank (BSB)
Time Frame: Up to 15 years
Up to 15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Target PharmaSolutions, Inc.

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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 1, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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