Research and Application for New Clinical Diagnosis and Treatment System for HBV Related HCC Liver Transplantation

May 7, 2024 updated by: First People's Hospital of Hangzhou

The Impact of FKBP12 on the Prognosis and Sirolimus Administration in Liver Transplantation Recipients With Hepatocellular Carcinoma: A Single-center Retrospective Cohort Study

The study evaluated the protein expression levels of FK506-binding protein 12 (FKBP12) in hepatocellular carcinoma (HCC) and paracancerous tissues using immunohistochemistry (IHC). This study aimed to determine the role of FKBP12 in the outcome of liver transplantation recipients with HCC, especially those exceeding the Milan criteria. In addition, we explored how sirolimus administration affected LT recipients'prognosis depending on different FKBP12 expression, aiming to provide some advice for clinical sirolimus application after LT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

178

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Deceased donor LT surgery was performed in all recipients at our center between January 1, 2015 and January 1, 2021. China Liver Transplant Registry database (http://www.cltr.org) was used to obtain clinical information about patients, which included age, gender, pathological characteristics, pre-LT alpha-fetoprotein (AFP), loco-regional therapy (including transcatheter arterial chemoembolization (TACE) and radiofrequency ablation (RFA)) before LT, model for end-stage liver disease (MELD) score, Child-Pugh score, hepatitis B virus status, sirolimus administration, date of surgery, recurrence, last follow up, and death. LT recipients were required for a follow-up examination every 3 months.

Description

Inclusion Criteria:

  • (1) pathologically confirmed HCC (2) full post-LT follow-up record

Exclusion Criteria:

  • (1)sirolimus treatment less than 30 days or after tumor recurrence (2)died within 90 days (3)underwent multiple-organ transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
high FKBP12 expression
The immunoreactive score (IRS), calculated by multiplying the staining intensity grades by the proportion of positive cells, was used to assess the expression levels of FKBP12. IRS (8-12) represented high expression levels.
Genetic: FKBP12 expression
The expressions of FKBP12 were determined by immunohistochemistry (IHC) , and the immunoreactive score (IRS), calculated by multiplying the staining intensity grades by the proportion of positive cells, was used to assess the expression levels of FKBP12. IRS (0-7) represented low expression levels, and IRS (8-12) represented high expression levels.
Other Names:
  • sirolimus
low FKBP12 expression
The immunoreactive score (IRS), calculated by multiplying the staining intensity grades by the proportion of positive cells, was used to assess the expression levels of FKBP12. IRS (0-7) represented low expression levels.
Genetic: FKBP12 expression
The expressions of FKBP12 were determined by immunohistochemistry (IHC) , and the immunoreactive score (IRS), calculated by multiplying the staining intensity grades by the proportion of positive cells, was used to assess the expression levels of FKBP12. IRS (0-7) represented low expression levels, and IRS (8-12) represented high expression levels.
Other Names:
  • sirolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 2015.1.1-2021.1.1
the length of months between surgery and the last follow-up or death
2015.1.1-2021.1.1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First People's Hospital of Hangzhou

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

May 7, 2024

First Submitted That Met QC Criteria

May 7, 2024

First Posted (Actual)

May 10, 2024

Study Record Updates

Last Update Posted (Actual)

May 10, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018768

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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