The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Incorporation of Protein Induced by Vitamin K Absence or Antagonist-II Into Transplant Criteria Expands Beneficiaries of Liver Transplantation for Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05907772
Recruitment Status : Completed
First Posted : June 18, 2023
Last Update Posted : June 18, 2023
Sponsor:
Information provided by (Responsible Party):
Xiao Xu, Zhejiang University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is a multi-center study in China to investigate the role of PIVKA-II in HCC recipient selection and prognostic stratification by analyzing the data of 522 recipients with HCC registered in the China Liver Transplant Registry.

Condition or disease Intervention/treatment
Cancer of Liver Other: No intervention

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 522 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Incorporation of Protein Induced by Vitamin K Absence or Antagonist-II Into Transplant Criteria Expands Beneficiaries of Liver Transplantation for Hepatocellular Carcinoma: A Multi-center Retrospective Cohort Study in China
Actual Study Start Date : August 27, 2022
Actual Primary Completion Date : October 25, 2022
Actual Study Completion Date : November 10, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Recipients with preoperative PIVKA-II≤240mAU/mL Other: No intervention
No intervention
Recipients with preoperative PIVKA-II>240mAU/mL Other: No intervention
No intervention


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Overall survival [ Time Frame: January 2015 to December 2020 ]
    the overall survival of liver transplant recipient with HCC


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
A total of 522 HCC patients underwent liver transplant with pre-operative PIVKA-II records were studied.
Criteria

Inclusion Criteria:

  • The HCC patients received LT with pre-operative PIVKA-II records performed from January 2015 to December 2020, whose clinicopathological data were registered in the CLTR.

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 or incomplete important parameters records.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05907772


Locations
Layout table for location information
China, Zhejiang
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Sponsors and Collaborators
Zhejiang University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Xiao Xu, Professor, Zhejiang University
ClinicalTrials.gov Identifier: NCT05907772    
Other Study ID Numbers: CT2023-ZJU-OBS1
First Posted: June 18, 2023    Key Record Dates
Last Update Posted: June 18, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Hepatocellular
Liver Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases