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

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ClinicalTrials.gov Identifier: NCT03894917
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : December 14, 2020
Sponsor:
Information provided by (Responsible Party):
Sukeshi Patel, The University of Texas Health Science Center at San Antonio

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.

Condition or disease Intervention/treatment
Carcinoma, Hepatocellular Other: Comprehensive Geriatric Assessment (CGA)

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.

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Study Type : Observational
Estimated Enrollment : 84 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterizing Disease Biology, Treatment Patterns and Toxicity in Older Adults With Advanced Hepatocellular Carcinoma
Actual Study Start Date : September 13, 2019
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : January 1, 2025

Group/Cohort Intervention/treatment
Group 1
Participants 65 years or older
Other: Comprehensive Geriatric Assessment (CGA)
Assessments will be done for participants that are 65 years or older.

Group 2
Participants less than 65 years



Primary Outcome Measures :
  1. 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. ]
    Collection of the participants disease characteristics, clinical and treatment data. Comprehensive geriatrics assessments will be done using bilingual assessments in English and Spanish.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Newly diagnosed with advanced hepatocellular carcinoma (HCC) that cannot be removed with surgery.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03894917


Contacts
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Contact: Maggie Tomasini, MPH 210-450-0507 tomasinim@uthscsa.edu

Locations
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United States, Texas
Mays Cancer Center Recruiting
San Antonio, Texas, United States, 78229
Contact: Gina Alvarez, RN    210-450-5893    alvarezg1@uthscsa.edu   
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
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Principal Investigator: Sukeshi Patel Arora, MD Mays Cancer Center
Additional Information:
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Responsible Party: Sukeshi Patel, John Eiler Endowed Professorship in Cancer Research, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT03894917    
Other Study ID Numbers: CTMS 19-0010
HSC20190202H ( Other Identifier: University of Texas Health Science Center- San Antonio )
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: December 14, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases