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NCT06409507 Clinical Trial

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

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06409507
Other study ID # 2018768
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2015
Est. completion date August 1, 2023

Study information
Verified date March 2024
Source First People's Hospital of Hangzhou
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 178
Est. completion date August 1, 2023
Est. primary completion date January 1, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
First People's Hospital of Hangzhou

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival the length of months between surgery and the last follow-up or death 2015.1.1-2021.1.1
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