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Hepatocellular CancerNCT02954094

A Longitudinal Observational Study of the Natural History and Management of Patients With HCC

An observational study of Hepatocellular Cancer, run by Target PharmaSolutions, Inc. at 71 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Cancer
How many people
10,000 participants
Where
71 sitesin 5 countries
Study dates
Dec 2016to Feb 2027
How long will I take part?
15 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients being managed for HCC

Who may be able to join

  • 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)

Who cannot join

  • 1. Inability to provide written informed consent

Trial locations and contacts

71 sites in 5 countries.

71 sites in 5 countries

United States52 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Piedmont Atlanta Hospital

    Atlanta, Georgia, 30309

  • Piedmont Cancer Institute

    Atlanta, Georgia, 30318

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Mercy Medical Center, GI Research

    Baltimore, Maryland, 21202

  • Johns Hopkins University

    Baltimore, Maryland, 21205

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29403

  • Center for Liver Disease and Transplant at CMC

    Charlotte, North Carolina, 28204

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Northwestern University Division of Gastroenterology and Hepatology

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • Gastro Florida

    Clearwater, Florida, 33762

  • Clinical Research Institute@ Methodist Dallas Medical Center

    Dallas, Texas, 75203

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-8887

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Baylor Scott & White All Saints

    Fort Worth, Texas, 76104

  • University of Florida Hepatology Research at CTRB

    Gainesville, Florida, 32610-0272

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Research Specialists of Texas

    Houston, Texas, 77030

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Southern Therapy and Advanced Research (STAR) LLC

    Jackson, Mississippi, 39216

  • University of Florida Health Gastroenterology

    Jacksonville, Florida, 32207

  • University of Arkansas

    Little Rock, Arkansas, 72205

  • University of Southern California/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • University of Wisconsin

    Madison, Wisconsin, 53705-2281

  • Northwell Health - Center for Liver Diseases

    Manhasset, New York, 11030

  • Schiff Center for Liver Diseases/University of Miami

    Miami, Florida, 33136

  • Vanderbilt University Medical Center - GI Research Office

    Nashville, Tennessee, 37212

  • Rutgers-Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901

  • Tulane University

    New Orleans, Louisiana, 70112

  • NYU Langone Health

    New York, New York, 10016

  • Weill Cornell Medical College

    New York, New York, 10021

  • Columbia University

    New York, New York, 10032

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68106

  • Stanford University

    Palo Alto, California, 94304

  • California Liver Research Institute

    Pasadena, California, 91105

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Banner University Medical Center

    Phoenix, Arizona, 85006

  • Providence Health & Services Cancer Clinical Trials

    Portland, Oregon, 97213

  • Bon Secours Liver Institute of Virginia

    Richmond, Virginia, 23226

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of California-Davis

    Sacramento, California, 95817

  • University of California

    San Francisco, California, 94158

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Saint Louis University

    St Louis, Missouri, 63110

  • Tampa General Medical Group

    Tampa, Florida, 33606

  • Georgetown University

    Washington D.C., District of Columbia, 20007

  • Wenatchee Valley Hospital & Clinics

    Wenatchee, Washington, 98801

Other trials in United States

Germany8 sites

  • Universitätsklinikum Aachen

    Aachen

  • Charité - Universitätsmedizin Berlin

    Berlin

  • Universitätsklinikum Düsseldorf

    Düsseldorf

  • Universitätsklinikum Frankfurt

    Frankfurt

  • Medizinische Hochschule Hannover

    Hanover

  • Universitätsklinikum Leipzig

    Leipzig

  • Universitätsklinikum Magdeburg

    Magdeburg

  • Universitätsmedizin Mainz

    Mainz

Other trials in Germany

Spain5 sites

  • Hospital Puerta de Hierro Majadahonda

    Madrid

  • Clínica Universidad de Navarra

    Pamplona

  • Hospital Universitario Marques de Valdecilla

    Santander

  • Hospital Universitario Virgen del Rocío

    Seville

  • Hospital Universitario Politècnic La Fe

    Valencia

Other trials in Spain

Italy4 sites

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan

  • A.O.U.P. di Palermo

    Palermo

  • Humanitas Mirasole IRCCS

    Rozzano

  • IRCCS "Casa Sollievo della Sofferenza"

    San Giovanni Rotondo

Other trials in Italy

France2 sites

  • CHU de Nice - Hôpital L'Archet 2

    Nice

  • Hôpitaux Universitaires Paris Centre

    Paris

Other trials in France

About this study

Official title: 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.

Medical subject headings
Liver Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Up to 15 years

Secondary outcomes (3)

  1. Evaluate the impact of HCC treatment interventions and concomitant medications on comorbid conditions and liver function

    Measured: Up to 15 years

  2. Evaluate patient-reported outcomes measures during the natural course of HCC and management with HRQoL questionnaires

    Measured: Up to 15 years

  3. Establish a Biorepository Specimen Bank (BSB)

    Measured: Up to 15 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,000 participants (estimated)
Target duration
15 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02954094
Sponsor's protocol ID
TARGET-HCC
Status last verified
Apr 2026
First submitted
1 Nov 2016
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33681685

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatocellular Cancer, run by Target PharmaSolutions, Inc. at 71 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Germany, Spain, Italy, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02954094, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.

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