A 5-year Longitudinal Observational Study of the Natural History and Management of Patients With HCC
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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.
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 5 years ]
Secondary Outcome Measures :
Evaluate the impact of HCC treatment interventions and concomitant medications on comorbid conditions and liver function [ Time Frame: Up to 5 years ]
Evaluate patient-reported outcomes measures during the natural course of HCC and management with HRQoL questionnaires [ Time Frame: Up to 5 years ]
Establish a Biorepository Specimen Bank (BSB) [ Time Frame: Up to 5 years ]
Biospecimen Retention: Samples With DNA
Patients enrolled in TARGET-HCC may be invited to participate in the Biorepository Specimen Bank (BSB). Blood samples and tissue samples for biomarker and DNA assays will be collected on a voluntary basis and participation in this project will not affect participation in the main study. These samples will be shipped to a central repository for storage to use in future studies. Samples stored at the biorepository will be identified only with the participant's unique study ID number and the date that the sample was obtained. This link between the participant's study ID number and their name will be available only at the site where the samples were obtained.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Adult patients being managed for HCC
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)