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Active, not recruitingNCT02954094Updated Apr 17, 2026

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

An observational study in Hepatocellular Cancer, sponsored by Target PharmaSolutions, Inc.. Active, not recruiting at 71 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-17.

Sponsored by Target PharmaSolutions, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Hepatocellular Cancer

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In context

Liver Neoplasms

1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 200 across 350 observational studies indexed under Liver Neoplasms.

Browse Liver Neoplasms studies →

Lead sponsor

Target PharmaSolutions, Inc. is the lead sponsor of 16 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients being managed for HCC

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

Exclusion Criteria:

1. Inability to provide written informed consent

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Target follow-up
15 Years
Patient registry
Yes
Biospecimen retention
Samples with dna
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What researchers measure

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

    Time frame: Up to 15 years

Secondary outcomes

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

    Time frame: Up to 15 years

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

    Time frame: Up to 15 years

  3. Establish a Biorepository Specimen Bank (BSB)

    Time frame: Up to 15 years

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Study locations

71 sites
  • 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
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References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02954094
Lead sponsor
Target PharmaSolutions, Inc.
Responsible party
Sponsor
First posted
Nov 3, 2016
Start date
Dec 2016
Primary completion
Feb 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Apr 17, 2026

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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