Hepatocellular Carcinoma

Early detection and prognosis of hepatocellular carcinoma

Enrollment status: Actively enrolling

Primary objective

To evaluate the usefulness of new markers found in blood that may help to diagnose hepatocellular carcinoma (HCC) early among people with cirrhosis. If we can establish new tumor markers for the detection of this tumor at early stage, which are currently lacking, this information could be applied to patients at the highest risk of HCC. We plan to store blood for this and future studies that may lead to better tests for the early detection of HCC.

Main inclusion criteria

  • Able and willing to provide written informed consent

  • Age ≥18 years of age

  • AFP lab result within 180 days prior to date of consent

  • All other lab results within 180 days prior to date of consent

  • Ultrasound or other imaging within 6 months prior to consent OR up to 2 weeks after consent showing no liver mass

  • Diagnosis of cirrhosis based one or more of the following:

    • Histology

    • US or CT showing cirrhotic appearing liver with splenomegaly and platelet count
      of < 120 mm³

    • Esophageal or gastric varicies on endoscopy AND presence of chronic liver disease

  • MELD ≤ 15 OR INR is ≤ 1.5, total bilirubin is ≤ 1.7 and patient has a history of intrinsic renal disease

Main exclusion criteria

  • Clinical evidence of significant hepatic decompensation

    • Refractory ascites

    • Grade 3–4 encephalopathy

    • Hepatorenal syndrome

    • Child Class C

  • AFP ≥ 20 ng/ml without proof of a dynamic CT scan or triple phase MRI within 3 months prior to consent OR up to 2 weeks after consent indicating no mass suggestive of HCC

  • Detection of HCC at initial evaluation

  • Significant co-morbid medical conditions with life expectancy less than 1 year

  • Cancer history within the last 5 years (excluding non-melanoma skin cancer)

  • Need for long-term immunosuppressive therapy for solid organ transplant

  • Prior solid organ transplant

Principal investigator

Contact persons