A 5-year Longitudinal Observational Study of the Natural History and Management of Patients with Hepatocellular Carcinoma
Primary Aims
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
Secondary Aims
1. Evaluate the impact of HCC treatment interventions and concomitant medications on comorbid conditions and liver function
2. Evaluate patient-reported outcomes measures during the natural course of HCC and management with HRQoL questionnaires
3. Establish a Biorepository Specimen Bank (BSB)
Exploratory Aims
1. Investigate optimal type, duration, and sequence/combination of treatment interventions for HCC used in usual clinical practice
2. Perform biomarker analyses to identify potential markers predictive of response patterns or side effect profiles
3. Generate hypotheses that may lead to further investigations regarding natural course and treatment of HCC
- RWJBarnabas Health
- Robert Wood Johnson University Hospital, New Brunswick
- Rutgers University
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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.