Characterizing Disease Biology, Treatment and Toxicity in Older Adults With Hepatocellular Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Comprehensive Geriatric Assessment (CGA).
- Who it may be relevant to
- Registry conditions: Carcinoma, Hepatocellular. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Characterizing Disease Biology, Treatment Patterns and Toxicity in Older Adults With Advanced Hepatocellular Carcinoma
Overview
This is an observational, prospective cohort study that will recruit a diverse sample of 84 participants with newly diagnosed with unresectable, advanced hepatocellular carcinoma (HCC) at the UT Health Cancer Center in San Antonio. This study uses geriatric assessment tools with participants 65 years and older and collects adverse events and exploratory markers of aging for all participants.
Detailed description
The results from this study will allow us to identify unique disease characteristics of older participants and to study treatment patterns that may be barriers to treatment and risk factors for increased morbidity. Characteristics of Comprehensive Geriatric Assessment will be obtained prior to standard interventional treatment for participants that are 65 years or older. Observations will be made of treatment toxicities and cellular senescence with treatment outcomes. Findings from this study will result in the development of R01 intervention studies that develop and validate a treatment algorithm based on these associations to provide older adults with a personalized treatment plan.
Interventions
- Other Comprehensive Geriatric Assessment (CGA)
Assessments will be done for participants that are 65 years or older.
Primary outcome measures
- Characterize the Change in disease and treatment patterns of advanced hepatocellular carcinoma (HCC) in older patients in the US. [Time frame: will be collected at time points: at screening, Month 1, Month 2, Month 4, Month 6, Month 8, Month 10 and Month 12.]
Eligibility criteria
Inclusion criteria
- Histologically or radiographically (CT or MRI) confirmed newly diagnosed hepatocellular carcinoma.
- Age 18 years and older.
- Patients with advanced, unresectable HCC as determined by the treating physician.
Exclusion criteria
- Patients with resectable HCC who are still candidates for locoregional therapy
- Patients receiving prior systemic or locoregional therapy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mays Cancer Center — San Antonio
Identifiers
NCT: NCT03894917 · CTMS 19-0010 · HSC20190202H