The Texas Hepatocellular Carcinoma Consortium (THCCC)

Study ID
STU 062015-076

Study Sites

  • UT Southwestern Ambulatory Services

Contact
Carrie Manwaring
214/645-6220
carrie.manwaring@utsouthwestern.edu

Principal Investigator
Jorge Marrero, M.D.

Summary

aims 1 and 2 will use the data and specimens collected from a large cohort of patients with cirrhosis to address HCC etiology but all assays and data analyses will be performed retrospectively and therefore have no impacts on participants' clinical management. Therefore the proposed cohort specimen and data collection and the research conducted in aims 1 and 2 have minimum risks to participants (blood draw and the need to ensure patient identifying information confidentiality).

Primary endpoint - the main clinical outcome is the development of HCC. We will consider all HCC cases detected at least 1 month after an HCC-free baseline assessment.

Secondary endpoints to be evaluated for this study:

a. Hepatic Decompensation
i. ascites: defined by presence of new or worsening ascites on imaging test or by requiring paracentesis as determined by treating physician
ii. Hepatic encephalopathy. By requiring up-titration of therapy with initiation of lactulose or any adjunct agent as determined by treating physician
iii. new gastroesophageal variceal bleeding
iv. Jaundice: a bilirubin level [Greater Than] 3 ng/dl
v. Hepatorenal Syndrome types 1 or 2, as determined by treating physician
b. increase in CTP score [Greater Than] 2 points or increase in MeLD score by 5 points?
c. Listing or receiving a Liver Transplantation as determined by treating physician
d. overall survival

Participant Eligibility

5.1.1.1 Able and willing to provide written informed consent and HIPAA
Authorization.
5.1.1.2 Age > 18 years of age
5.1.1.3 Diagnosis of cirrhosis based on at least one of the following:
i. Histology, liver biopsy obtained within 5 years of baseline enrollment/registration.
ii. US, CT or MRI showing a cirrhotic appearing liver with portal (defined as presence of intraabdominal varices, presence of collaterals and/or recanalized umbilical vein) hypertension and/or splenomegaly. The imaging study must have been obtained within 5 years of baseline enrollment/registration.
iii. Elastography, done by ultrasound or MRI showing advanced fibrosis
iv. A serum marker of hepatic fibrosis (FIB4, APRI or Fibrotest/Fibrosure) showing cirrhosis or stage 4 fibrosis obtained within 5 years of baseline enrollment/registration.
v. Presence of varices on endoscopy or imaging AND presence of a chronic liver disease