Hepatocellular Carcinoma Early Detection Strategy Study

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 12-008510
    Sponsor Protocol Number: 12-008510

About this study

The purpose of this study is to evaluate the usefulness of new markers found in blood that might help to diagnose of liver cancer (HCC) early among people with cirrhosis. We hope that this study will show that these new markers could identify HCC at an earlier stage where better treatment options are available.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

Eligibility criteria for controls are:

  •  Able and willing to provide written informed consent
  •  Age > 18 years of age
  •  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
  •  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:

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

  •  MELD < 15 OR INR is < 1.5, Total Bilirubin is < 1.7 and patient has a history of intrinsic renal disease

Exclusion Criteria

  •  Clinical evidence of significant hepatic decompensation

o Refractory ascites

o Grade 3-4 encephalopathy

o Hepatorenal syndrome

o Child Class C

  •  Listed for liver transplantation and noted for an "exception"
  •  Known AIDS related diseases
  •  Detection of HCC at initial evaluation
  •  Significant co-morbid medical conditions with life expectancy less than one 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Lewis Roberts, M.B., Ch.B., Ph.D.

Open for enrollment

Contact information:

Nasra Giama D.N.P., R.N.

(507)538-0097

Giama.Nasra@mayo.edu

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions