UT Southwestern Hepatocellular Carcinoma (HCC) Early Detection Study

Study ID
STU 092013-010

Study Sites

  • Clements University Hospital

Mobolaji Odewole

Principal Investigator
Amit Singal


Patients with chronic liver disease, cirrhosis, and/or 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. For aim 1, the relationship of patient factors to future HCC development will be assessed. We will use all data from non-HCC patients but will only use data up to 6 months prior to HCC diagnosis in HCC patients. For aim 2, we will compare aFP levels between patients with early stage HCC and those without HCC. early HCC will be defined by Milan criteria (one tumor [Less Than] 5 cm or 2-3 tumors, each [Less Than] 3 cm in max diameter without vascular invasion or metastases). For this aim, we will include data at time of HCC diagnosis. For aim 3, we will determine predictors of true positives and true negatives of aFP for diagnosis of HCC.

Participant Eligibility

* Able and willing to provide written informed consent

* Age > 18 years of age

* Diagnosis of cirrhosis or HCC based one of the following:
o Histology
o Clinical diagnosis of chronic liver disease
o Clinical diagnosis of cirrhosis
Cirrhotic appearing liver on imaging with evidence of portal hypertension OR
Evidence of portal hypertension in the presence of chronic liver disease
o Clinical diagnosis of HCC