Clinical trial NCT02954094: A Longitudinal Observational Study of the Natural History and Management of Patients With HCC
Official title: A Longitudinal Observational Study of the Natural History and Management of Patients With Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Cancer
Lead sponsor: Target PharmaSolutions, Inc.
Sponsor class: INDUSTRY
First posted: 2016-11-03
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients being managed for HCC

Brief 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.


Eligibility criteria: 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

Primary outcomes:
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
timeFrame: Up to 15 years
Secondary outcomes:
measure: Evaluate the impact of HCC treatment interventions and concomitant medications on comorbid conditions and liver function
timeFrame: Up to 15 years
measure: Evaluate patient-reported outcomes measures during the natural course of HCC and management with HRQoL questionnaires
timeFrame: Up to 15 years
measure: Establish a Biorepository Specimen Bank (BSB)
timeFrame: Up to 15 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas
state: Arkansas
city: Los Angeles
country: United States
facility: University of Southern California/Norris Comprehensive Cancer Center
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Pasadena
country: United States
facility: California Liver Research Institute
state: California
city: Sacramento
country: United States
facility: University of California-Davis
state: California
city: San Francisco
country: United States
facility: University of California
state: California
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Clearwater
country: United States
facility: Gastro Florida
state: Florida
city: Gainesville
country: United States
facility: University of Florida Hepatology Research at CTRB
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Health Gastroenterology
state: Florida
city: Miami
country: United States
facility: Schiff Center for Liver Diseases/University of Miami
state: Florida
city: Tampa
country: United States
facility: Tampa General Medical Group
state: Florida
city: Atlanta
country: United States
facility: Piedmont Atlanta Hospital
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Cancer Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Division of Gastroenterology and Hepatology
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Baltimore
country: United States
facility: Mercy Medical Center, GI Research
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Jackson
country: United States
facility: Southern Therapy and Advanced Research (STAR) LLC
state: Mississippi
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New Brunswick
country: United States
facility: Rutgers-Robert Wood Johnson Medical School
state: New Jersey
city: Manhasset
country: United States
facility: Northwell Health - Center for Liver Diseases
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Center for Liver Disease and Transplant at CMC
state: North Carolina
city: Portland
country: United States
facility: Providence Health & Services Cancer Clinical Trials
state: Oregon
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center - GI Research Office
state: Tennessee
city: Dallas
country: United States
facility: Clinical Research Institute@ Methodist Dallas Medical Center
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Baylor Scott & White All Saints
state: Texas
city: Houston
country: United States
facility: Research Specialists of Texas
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Richmond
country: United States
facility: Bon Secours Liver Institute of Virginia
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Hospital & Clinics
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Nice
country: France
facility: CHU de Nice - Hôpital L'Archet 2
city: Paris
country: France
facility: Hôpitaux Universitaires Paris Centre
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Palermo
country: Italy
facility: A.O.U.P. di Palermo
city: Rozzano
country: Italy
facility: Humanitas Mirasole IRCCS
city: San Giovanni Rotondo
country: Italy
facility: IRCCS "Casa Sollievo della Sofferenza"
city: Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro Majadahonda
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital Universitario Politècnic La Fe
Study officials:
References:
citation: 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.