A Study of Extracellular RNA Markers of Liver Disease and Cancer

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
    • Jacksonville, Florida: 14-004560
    • Rochester, Minnesota: 14-004560
    NCT ID: NCT02908048
    Sponsor Protocol Number: 14-004560

About this study

This study is being done to collect and store samples of blood from patients with liver disease for a research study to be able to find a new and better way to detect liver cancer.

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

  • Cases
    • Age > 18 years
    • Lab results (other than AFP) must be within the past 90 days 
    • Able and willing to provide written informed consent
    • Diagnosis of HCC
  • Controls
    • Age > 18 years
    • Ultrasound or other imaging within 6 months prior to enrollment or up to 2 weeks after consent showing no liver mass
    • AFP < 20 ng/ml
    • AFP ≥ 20 ng/ml if dynamic CT scan or triple phase MRI within 3 months prior to enrollment or up to 2 weeks after consent reveals no mass suggestive of HCC
    • AFP lab result must be within past 180 days
    • Able and willing to provide written informed consent
    • Diagnosis of cirrhosis

Exclusion Criteria

  • Cases 
    • Previous 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
  • Controls
    • Age < 18 years
    • Prior solid organ transplant
    • Previous or current cancer history within the past 5 years (excluding non-melanoma skin cancer)
    • Undiagnosed liver mass

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Tushar Patel, M.B., Ch.B.

Open for enrollment

Contact information:

Lori Chase CCRP

(904)953-3464

Chase.Lori@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Tushar Patel, M.B., Ch.B.

Contact us for the latest status

Contact information:

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

(507)266-3239

roberts.lewis@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20358444

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