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

Carcinoma, Hepatocellular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03894917
• Other study ID #: CTMS 19-0010
• Secondary ID: HSC20190202H
• Status: Recruiting
• Start date: September 13, 2019
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Maggie Tomasini, MPH
• Phone: 210-450-0507
• Email: tomasinim[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Other:
• Comprehensive Geriatric Assessment (CGA)
Assessments will be done for participants that are 65 years or older.

Locations

Country	Name	City	State
United States	Mays Cancer Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

External Links

•   Mays Cancer Center