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:
- Able and willing to provide written informed consent.
- Age ≥ 18 years of age.
- AFP lab result within past 180 days.
- All other lab results within past 90 days.
- Diagnosis HCC based on one of the following:
- Histology (required if only one lesion < 2 cm is present) – Must have CT/MRI to calculate stage;
- Two imaging tests, with at least one (CT/MRI/Angiography) within the past 3 months or up to 2 weeks after consent showing evidence of arterial hypervascularization, and the other within the past 6 months (US, CT, MRI/Angiography) indicating a mass in the liver.
- MELD < 15 OR INR is < 1.5, Total Bilirubin is < 1.7 and patient has a history of intrinsic renal disease.
Exclusion Criteria:
- Prior or current therapeutic treatment of HCC.
- Cancer history within the last 5 years (excluding non-melanoma skin cancer).
- Participation in a treatment trial for HCC, before blood and data obtained.
- Undiagnosed liver mass.
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