NCT06018857

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
31mo left

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
May 2017Dec 2028

Study Start

First participant enrolled

May 11, 2017

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 31, 2023

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

11.6 years

First QC Date

August 24, 2023

Last Update Submit

March 5, 2026

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

  • 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.

  • Overall Survival

    From date of surgery to date of death, up to 10 years after the surgery.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients (age\>18 years) undergoing Liver transplant for hepatocellular carcinoma

You may qualify if:

  • Adult patients (age\>18 years) undergoing Liver transplant for hepatocellular carcinoma

You may not qualify if:

  • Patients under 18 years old
  • Patients who do not have hepatocellular carcinoma
  • patients who have hepatocellular carcinoma but do not undergo liver transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

  • Wehrle CJ, Raj R, Maspero M, Satish S, Eghtesad B, Pita A, Kim J, Khalil M, Calderon E, Orabi D, Zervos B, Modaresi Esfeh J, Whitsett Linganna M, Diago-Uso T, Fujiki M, Quintini C, Kwon CD, Miller C, Pinna A, Aucejo F, Hashimoto K, Schlegel A. Risk assessment in liver transplantation for hepatocellular carcinoma: long-term follow-up of a two-centre experience. Int J Surg. 2024 May 1;110(5):2818-2831. doi: 10.1097/JS9.0000000000001104.

    PMID: 38241354DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Federico Aucejo, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director Liver Cancer Program

Study Record Dates

First Submitted

August 24, 2023

First Posted

August 31, 2023

Study Start

May 11, 2017

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)