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NCT06331260 Clinical Trial

Assessment of AFP and PIVKA-II as Prognostic Indicators in Liver Transplantation for Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:
Assessment of AFP and PIVKA-II as Prognostic Indicators in Liver Transplantation for Hepatocellular Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06331260
Other study ID # CT2024-ZJU-OBS2
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2024
Est. completion date April 1, 2028

Study information
Verified date March 2024
Source Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

As key biomarkers in HCC, AFP and PIVKA-II reflects biological features of tumor and has been widely applied for clinical diagnosis. Previous studies reported preoperative AFP and PIVKA-II are related to HCC recipient long-term survival after liver transplantation. However, there is no prospective study supporting these conclusions. This study aims to prospective collect liver transplantation cases from multiple transplant centers and further evaluate the prognostic role of preoperative AFP and PIVKA-II in liver transplantation for HCC.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 600
Est. completion date April 1, 2028
Est. primary completion date April 1, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Diagnosis of HCC based on CT or MRI imaging or needle biopsy confirming a histologic diagnosis of HCC. 2. Patients undergoing deceased donor liver transplantation for the first time. Exclusion Criteria: (1) patients who received split LT or simultaneous transplantation, (2) patients who received re-transplantation, (3) patients with macroscopic portal vein tumor thrombosis or other macrovascular invasion, (4) patients with incomplete follow-up, (5) taking warfarin at the time of LT biomarker measurements

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Zhejiang University Shulan (Hangzhou) Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Recurrence free survival rate 2024.4.1-2028.4.1
Primary Overall survival rate 2024.4.1-2028.4.1
Primary Tumor recurrence rate 2024.4.1-2028.4.1
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