A 5-year Longitudinal Observational Study of the Natural History and Management of Patients with Hepatocellular Carcinoma (HCC)

Study ID
STU 032017-027

Study Sites

  • UT Southwestern Ambulatory Services

Contact
Mobolaji Odewole
214/645-9748
Mobolaji.Odewole@UTSouthwestern.edu

Principal Investigator
Amit Singal, M.D.

Summary

Patients with HCC will be enrolled in the uT Southwestern Medical Center and Parkland Health and Hospital Liver (and Liver Transplant) Clinics and Liver Cancer Clinics. Potentially eligible patients will be identified by clinic providers and referred for study inclusion per the discretion of the clinic provider and patient. When notified, a study coordinator will interview the patient to confirm that they meet eligibility criteria. The study coordinator will administer informed consent and collect the study data and specimens. it is expected that the enrollment visit will take about 30-45 minutes and will be a part of their routine medical care visit done by their hepatologist or oncologist. We will obtain variables of interest either through the electronic medical record or via patient interview at time of enrollment. We will assess for any changes in these data longitudinally, as patients are seen in clinic for their routine clinical care. We will collect blood at baseline and follow-up visits during course of standard medical care.

The annual rate of HCC ranges from 2-6% per year. This risk is cumulative over time, so we anticipate approximately 10% of patients will develop HCC after being followed for median of 3-4 years. The study will help 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.

Participant Eligibility

1) Able and willing to provide written informed consent.
2) Male or female patients, age >=18 years
3) 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).