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Registry 17-009: Multi-Institutional Study Examining Patients With HCC Undergoing Liver Transplantation

Sponsor
Federico Aucejo (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06018857
Collaborator
Ohio State University (Other)
1,000
Enrollment
2
Locations
78.7
Anticipated Duration (Months)
500
Patients Per Site
6.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a registry study examining patients with HCC undergoing liver transplantation including outcomes and predictors of recurrence

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Registry 17-009: Multi-Institutional Study Examining Patients With HCC Undergoing Liver Transplantation
    Actual Study Start Date :
    May 11, 2017
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Recurrence Free Survival [From date of surgery to date of identified cancer recurrence through either clinical judgement or scans. This is assessed up to 10 years after the surgery.]

    2. Overall Survival [From date of surgery to date of death, up to 10 years after the surgery.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adult patients (age>18 years) undergoing Liver transplant for hepatocellular carcinoma
    Exclusion Criteria:

    • Patients under 18 years old

    • Patients who do not have hepatocellular carcinoma

    • patients who have hepatocellular carcinoma but do not undergo liver transplantation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    2 Ohio State University Columbus Ohio United States 43210

    Sponsors and Collaborators

    • Federico Aucejo
    • Ohio State University

    Investigators

    • Principal Investigator: Federico Aucejo, MD, The Cleveland Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Federico Aucejo, Director Liver Cancer Program, The Cleveland Clinic
    ClinicalTrials.gov Identifier:
    NCT06018857
    Other Study ID Numbers:
    • 17-009
    First Posted:
    Aug 31, 2023
    Last Update Posted:
    Aug 31, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma, Hepatocellular

    Study Results

    No Results Posted as of Aug 31, 2023