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

NCT03894917 | Recruiting DMC

• 2 other identifiers: CTMS 19-0010HSC20190202H
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Group 1

Participants 65 years or older

Other: Comprehensive Geriatric Assessment (CGA)

Group 2

Participants less than 65 years

Interventions

Comprehensive Geriatric Assessment (CGA) OTHER

Assessments will be done for participants that are 65 years or older.

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Newly diagnosed with advanced hepatocellular carcinoma (HCC) that cannot be removed with surgery.

You may qualify if:

• 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.

You may not qualify if:

• Patients with resectable HCC who are still candidates for locoregional therapy
• Patients receiving prior systemic or locoregional therapy

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

Mays Cancer Center

San Antonio, Texas, 78229, United States

RECRUITING

Related Links

• Mays Cancer Center

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Sukeshi Patel Arora, MD

  Mays Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maggie Tomasini, MPH

CONTACT

210-450-0507; tomasinim@uthscsa.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: March 29, 2019
• Study Start: September 13, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)