Characterizing Disease Biology, Treatment and Toxicity in Older Adults With Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Characterizing Disease Biology, Treatment Patterns and Toxicity in Older Adults With Advanced Hepatocellular Carcinoma

Conditions
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Carcinoma, Hepatocellular

Intervention / Treatment
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* Other: Comprehensive Geriatric Assessment (CGA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Participants 65 years or older | Other: Comprehensive Geriatric Assessment (CGA)<br>* Assessments will be done for participants that are 65 years or older.<br>|
| Group 2<br>Participants less than 65 years | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize the Change in disease and treatment patterns of advanced hepatocellular carcinoma (HCC) in older patients in the US. | Collection of the participants disease characteristics, clinical and treatment data. Comprehensive geriatrics assessments will be done using bilingual assessments in English and Spanish. | will be collected at time points: at screening, Month 1, Month 2, Month 4, Month 6, Month 8, Month 10 and Month 12. |