Hepatocellular carcinoma Early Detection Strategy study (HEDS)

Study ID
STU 072012-029

Cancer Related

Healthy Volunteers

Study Sites

  • Clements University Hospital
  • Parkland Health & Hospital System

Carrie Manwaring

Principal Investigator
Jorge Marrero, M.D.


Hepatocellular carcinoma (HCC) is the 5th most common tumor worldwide, in the u.S., it is the tumor with second highest increase in incidence, and the incidence is expected to continue to rise over the next 2 decades mostly due to the hepatitis C (HCV) epidemic. Given that HCC most commonly occurs in patients with chronic liver disease (such as fatty liver and HCV infection), an early detection strategy should be performed targeting these patients. The current early detection strategy for HCC is ultrasound and alpha-fetoprotein (aFP) every 6 months. The performance characteristics are poor, leading to most patients being diagnosed at advanced stages in turn leading to the 3rd highest mortality rate for solid tumors. Therefore, an improvement in the overall early detection strategy is critical in order to improve outcomes. in addition, identification of risk factor may help tailor the early detection strategy in order to improve performance characteristics. We are proposing a prospective Phase 3 biomarker study of patients with cirrhosis in the u.S. This is funded by the nCi's early Detection Research network and involves prospectively following 1,550 patients with cirrhosis in 7 centers. Subjects will be followed every 6 months and serum, plasma and peripheral blood Dna will be collected and stored for biomarkers (aFP, DCP, aFP_L3) evaluation for their ability for early detection of HCC (aim 2). Data on demographics, family history, medical history, medications (prescription and none prescription), alcohol, tobacco, aflatoxin, and viral factors will be collected to identify risk factors for prognosis to HCC among cirrhotic patients (aim 3). This study will determine whether these markers (solo or in combination) can detect early stage HCC..

Participant Eligibility

Eligibility criteria for controls are:

* 1. Able and willing to provide written informed consent

* 2. Age > 18 years of age

* 3. Albumin, Bilirubin, Creatinine and INR (used to calculate MELD and Child Class) lab result date within 6 months prior to consent OR up to 2 weeks after consent

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

* 5. Diagnosis of cirrhosis based one or more of the following:
o Histology
o US, MRI or CT showing cirrhotic appearing liver with splenomegaly and platelet count of < 120 mm-3
o Elastography, done by ultrasound or MRI showing a cirrhotic liver
o A FibroTest result of F4 (stage 4), indicating cirrhosis
o Varices on endoscopy or an abdominal imaging test AND presence of chronic liver disease

* 6. MELD < 15 OR INR is < 1.5, Total Bilirubin is < 1.7 and patient has a history of intrinsic renal