Hepatocellular Cancer Clinical Trial
Official title:
A Longitudinal Observational Study of the Natural History and Management of Patients With Hepatocellular Carcinoma
| 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 |
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.
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Target PharmaSolutions, Inc. |
United States, France, Germany, Italy, Spain,
| 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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