Hepatocellular Carcinoma Early Detection Strategy Study
Overview
Tab Title Description
Study type
ObservationalDescribes 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.
Study IDs
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available