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

NCT06409507 | Completed

• 1 other identifier: 2018768
• Study Type: observational
• Target: 178
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hepatocellular Carcinoma; Liver Transplantation; Prognosis

Outcome Measures

Primary Outcomes (1)

• Overall survival

  the length of months between surgery and the last follow-up or death

  2015.1.1-2021.1.1

Study Arms (2)

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

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

Interventions

FKBP12 expression GENETIC

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.

Also known as: sirolimus

high FKBP12 expression; low FKBP12 expression

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: January 1, 2015
• Primary Completion: January 1, 2021
• Study Completion: August 1, 2023
• Last Updated: May 10, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share