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NCT02954094 Clinical Trial

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

Hepatocellular Cancer Clinical Trial

Official title:
A Longitudinal Observational Study of the Natural History and Management of Patients With Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02954094
Other study ID # TARGET-HCC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 2016
Est. completion date October 2024

Study information
Verified date June 2024
Source Target PharmaSolutions, Inc.
Contact Stephanie Harrison
Email sharrison@targetrwe.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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 future therapies across diverse populations.

Recruitment information / eligibility
Status Recruiting
Enrollment 10000
Est. completion date October 2024
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHU de Nice - Hôpital L'Archet 2 Nice
France Hôpitaux Universitaires Paris Centre Paris
Germany Universitätsklinikum Aachen Aachen
Germany Charité - Universitätsmedizin Berlin Berlin
Germany Universitätsklinikum Düsseldorf Düsseldorf
Germany Universitätsklinikum Frankfurt Frankfurt
Germany Medizinische Hochschule Hannover Hannover
Germany Universitätsklinikum Leipzig Leipzig
Germany Universitätsklinikum Magdeburg Magdeburg
Germany Universitätsmedizin Mainz Mainz
Italy 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
Spain Complejo Hospitalario Universitario A Coruña Coruña
Spain 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 Sevilla
Spain Hospital Universitario Politècnic La Fe Valencia
United States University of Michigan Ann Arbor Michigan
United States Emory University Hospital Atlanta Georgia
United States Piedmont Atlanta Hospital Atlanta Georgia
United States Piedmont Cancer Institute Atlanta Georgia
United States Johns Hopkins University Baltimore Maryland
United States Mercy Medical Center, GI Research Baltimore Maryland
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States Center for Liver Disease and Transplant at CMC Charlotte North Carolina
United States University of Virginia Charlottesville Virginia
United States Northwestern University Division of Gastroenterology and Hepatology Chicago Illinois
United States Rush University Medical Center Chicago Illinois
United States University of Chicago Chicago Illinois
United States Gastro Florida Clearwater Florida
United States Clinical Research Institute@ Methodist Dallas Medical Center Dallas Texas
United States University of Texas Southwestern Medical Center Dallas Texas
United States Henry Ford Health System Detroit Michigan
United States Baylor Scott & White All Saints Fort Worth Texas
United States University of Florida Hepatology Research at CTRB Gainesville Florida
United States Penn State Hershey Medical Center Hershey Pennsylvania
United States Research Specialists of Texas Houston Texas
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States Southern Therapy and Advanced Research (STAR) LLC Jackson Mississippi
United States University of Florida Health Gastroenterology Jacksonville Florida
United States University of Arkansas Little Rock Arkansas
United States University of Southern California/Norris Comprehensive Cancer Center Los Angeles California
United States University of Wisconsin Madison Wisconsin
United States Northwell Health - Center for Liver Diseases Manhasset New York
United States Schiff Center for Liver Diseases/University of Miami Miami Florida
United States Vanderbilt University Medical Center - GI Research Office Nashville Tennessee
United States Rutgers-Robert Wood Johnson Medical School New Brunswick New Jersey
United States Tulane University New Orleans Louisiana
United States Columbia University New York New York
United States NYU Langone Health New York New York
United States Weill Cornell Medical College New York New York
United States University of Nebraska Medical Center Omaha Nebraska
United States Stanford University Palo Alto California
United States California Liver Research Institute Pasadena California
United States University of Pennsylvania Philadelphia Pennsylvania
United States Banner University Medical Center Phoenix Arizona
United States Providence Health & Services Cancer Clinical Trials Portland Oregon
United States Bon Secours Liver Institute of Virginia Richmond Virginia
United States Virginia Commonwealth University Richmond Virginia
United States Mayo Clinic Rochester Minnesota
United States University of California-Davis Sacramento California
United States Saint Louis University Saint Louis Missouri
United States University of California San Francisco California
United States Harborview Medical Center Seattle Washington
United States Tampa General Medical Group Tampa Florida
United States Georgetown University Washington District of Columbia
United States Wenatchee Valley Hospital & Clinics Wenatchee Washington

Sponsors (1)
Lead Sponsor Collaborator
Target PharmaSolutions, Inc.

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Evaluate the impact of HCC treatment interventions and concomitant medications on comorbid conditions and liver function Up to 15 years
Secondary Evaluate patient-reported outcomes measures during the natural course of HCC and management with HRQoL questionnaires Up to 15 years
Secondary Establish a Biorepository Specimen Bank (BSB) Up to 15 years
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