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

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Enrolling

Conditions

Carcinoma, Hepatocellular

Treatments

Other: Comprehensive Geriatric Assessment (CGA)

Study type

Observational

Funder types

Other

Identifiers

NCT03894917
HSC20190202H (Other Identifier)
CTMS 19-0010

Details and patient eligibility

About

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.

Full 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.

Enrollment

84 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

84 participants in 2 patient groups

Group 1
Description:
Participants 65 years or older
Treatment:
Other: Comprehensive Geriatric Assessment (CGA)
Group 2
Description:
Participants less than 65 years

Trial contacts and locations

1

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Central trial contact

Maggie Tomasini, MPH

Data sourced from clinicaltrials.gov

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