A Longitudinal Observational Study of the Natural History and Management of Patients With HCC

Recruiting

• Conditions: Hepatocellular Cancer

• Registration Number: NCT02954094
• Lead Sponsor: Target PharmaSolutions, Inc.

Brief Summary

TARGET-HCC is a longitudinal, observational study of patients being managed for HCC in usual clinical practice. TARGET-HCC will create a research registry of participants with HCC within academic and community real-world practices in order to assess the safety and effectiveness of the entire spectrum of current and future therapies across diverse populations.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-01
• Study First Submitted QC: 2016-11-01
• Study First Posted: 2016-11-03
• Study Start: 2016-12-01
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-22
• Last Update Posted: 2025-07-23
• Primary Completion: 2025-10
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

1. Male or female patients, age ≥18 years
2. Patients with a histological/cytological or radiological diagnosis of HCC (mixed HCC cholangiocarcinoma may be included; patients who are candidates for surgical and non-surgical treatment, as well as those being followed without specific HCC therapy may be included)

Exclusion Criteria

1. Inability to provide written informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Establish a longitudinal observational cohort to understand the natural history and management of HCC, including the safety and outcomes of HCC treatment interventions utilized in usual clinical practice	Up to 15 years

Secondary Outcome Measures

Name	Time	Method
Evaluate the impact of HCC treatment interventions and concomitant medications on comorbid conditions and liver function	Up to 15 years
Evaluate patient-reported outcomes measures during the natural course of HCC and management with HRQoL questionnaires	Up to 15 years
Establish a Biorepository Specimen Bank (BSB)	Up to 15 years

Trial Locations

Locations (72)

Banner University Medical Center; 🇺🇸 Phoenix, Arizona, United States

University of Arkansas; 🇺🇸 Little Rock, Arkansas, United States

University of Southern California/Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

California Liver Research Institute; 🇺🇸 Pasadena, California, United States

University of California-Davis; 🇺🇸 Sacramento, California, United States

University of California; 🇺🇸 San Francisco, California, United States

Georgetown University; 🇺🇸 Washington, District of Columbia, United States

Gastro Florida; 🇺🇸 Clearwater, Florida, United States

University of Florida Hepatology Research at CTRB; 🇺🇸 Gainesville, Florida, United States

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