Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma

Overview

About this study

The primary objective of this study is to obtain de-identified, clinically-characterized whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of hepatocellular carcinoma (HCC).

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 - All Subjects:

  • Subject is 18 years of age or older.
  • Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of data, including personal health data, to the study investigator and sponsor. 

Inclusion Criteria - HCC Subjects:

  • Subject has a recent (within 6 months of enrollment) untreated clinically diagnosed hepatocellular carcinoma as defined by ≥1 cm lesion exhibiting arterial phase hyperenhancement in combination with washout appearance and/or capsule by 4 phase CT scan or multiphase contrast enhanced MRI or biopsy is positive for HCC.

Inclusion Criteria - Control Subjects:

  • Non-cancer subject undergoing routine imaging surveillance for HCC.
  • Definitive lack of HCC within 3 months prior to enrollment as defined by negative imaging, for HCC:
    • Control Group 1 - negative by ultrasound;
    • Control Group 2 - negative by CT or MRI.

Exclusion Criteria:

  • Known cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers).
  • Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
  • Prior or current treatment with sorafenib, regorafenib, or other treatment indicated for HCC.
  • Any HCC treatment prior to enrollment/blood sample collection (e.g., surgery, ablation, embolization, pharmacotherapy, radiotherapy, liver transplant or other treatment indicated for HCC).
  • IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.
  • Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
  • Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
  • Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

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

Closed for enrollment

More information

Publications

Publications are currently not available
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