NCT05643833

Brief Summary

This is a large-scale study in China to provide evidence and insights in the role of gender in LT for HCC by analyzing the data of 3769 recipients with HCC registered in the China Liver Transplant Registry.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,769

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 9, 2022

Completed
Last Updated

December 9, 2022

Status Verified

November 1, 2022

Enrollment Period

1.4 years

First QC Date

November 29, 2022

Last Update Submit

November 29, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    the overall survival of liver transplant recipient with HCC

    January 2015 to December 2020

Study Arms (4)

Male recipient

Other: no intervention

Female recipient

Other: no intervention

Male donor

Other: no intervention

Female donor

Other: no intervention

Interventions

no intervention

Female donorFemale recipientMale donorMale recipient

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A total of 3769 HCC patients underwent liver transplant with the age between 18-65 years old were studied.

You may qualify if:

  • The patients with liver transplants performed from January 2015 to December 2020, whose clinicopathological data were registered in the CLTR.

You may not qualify if:

  • Patients with following features were excluded: with concurrent other malignancies, pathologically-confirmed tumor types other than HCC, such as intrahepatic cholangiocarcinoma (ICC), combined hepatocellular cholangiocarcinoma (cHCC-CC), fibrolamellar hepatocellular carcinoma (FLC) or secondary metastatic tumor; without histological confirmation of HCC for transplantation. The patients who received living donor liver transplantation, split liver transplantation, reduced-size liver transplantation or simultaneous transplantation were also excluded. Next, pediatric patients (\<18 years) or senile patients (\>65 years) and those patients who died within six months after transplantation were also excluded. Finally, the patients with type-1 and type-2 portal vein tumor thrombus (PVTT), tumor metastasis, having doubtful or contradictory data or missing essential data for analysis, re-transplantation during follow-up time were excluded as well.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 29, 2022

First Posted

December 9, 2022

Study Start

January 1, 2021

Primary Completion

May 30, 2022

Study Completion

October 15, 2022

Last Updated

December 9, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations