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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06018857
Recruitment Status : Active, not recruiting
First Posted : August 31, 2023
Last Update Posted : January 30, 2024
Sponsor:
Collaborator:
Ohio State University
Information provided by (Responsible Party):
Federico Aucejo, The Cleveland Clinic

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is a registry study examining patients with HCC undergoing liver transplantation including outcomes and predictors of recurrence

Condition or disease
Hepatocellular Carcinoma

Study Design
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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Recurrence Free Survival [ Time Frame: 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 [ Time Frame: From date of surgery to date of death, up to 10 years after the surgery. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients (age>18 years) undergoing Liver transplant for hepatocellular carcinoma
Criteria

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
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06018857


Locations
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United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Federico Aucejo
Ohio State University
Investigators
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Principal Investigator: Federico Aucejo, MD The Cleveland Clinic
More Information
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Responsible Party: Federico Aucejo, Director Liver Cancer Program, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT06018857    
Other Study ID Numbers: 17-009
First Posted: August 31, 2023    Key Record Dates
Last Update Posted: January 30, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases