Prospective Liver Tumor (ProLiT) Database

• Conditions: Evidence of Liver Transplantation; Hepatocellular Carcinoma

• Registration Number: NCT01607788
• Lead Sponsor: University of Geneva, Switzerland

Brief Summary

The investigators propose a prospective, web-based database (developed within the framework of Quickbase, Intuit) which will allow an evaluation of the data for patients with a liver tumour who receive a liver transplant. Each site will continue to transplant according to their own criteria for inclusion on the waiting list. Each center will be responsible to enter a short list of data points at time of listing, transplant, and at 1 and 2 years post transplant. Data will be gathered prospectively through a web-based anaonymized database, and outcomes analyzed yearly X5 for tumour recurrence and patient survival.

Detailed Description

A previous retrospective study evaluated the UNOS database of liver transplant recipients for use of total tumor volume (TTV) and alphafetoprotein (AFP) as criteria for selection of candidates for liver transplantation. The results confirmed a prior publication demonstrating that tumors modestly beyond Milan size limitation and irrespective of tumor numbers can achieve excellent outcomes, while providing important insight into which tumors within Milan criteria remain with a high likelihood of recurrence (high AFP). The work has now been published in Hepatology.

The investigators propose a prospective evaluation of these composite criteria, using data from patients receiving a liver transplant in order to have a larger population. Centers will continue to transplant according to their own criteria for inclusion on the waiting list. Data will be gathered prospectively through a web-based database (Quickbase, Intuit) and outcomes analyzed yearly for 5 years follow-up for tumour recurrence and patient survival.

Each center will be responsible to enter a short list of data points for their patients at time of listing, time of transplant, and yearly post transplant. Data points have been kept to a minimum in the hope that this will encourage participation in this database.

The database will be set up with 3 levels of access:

1. data entry only (one at each site)

2. review site data and composite data from other sites(one at each site)

3. review all sites and aggregate (for analysis and publication) Sites will only be able to edit and review their own patient data. They will be able to view aggregate data from other sites from which all identifiers have been removed.

Data will not be used to manage patient care in any way. The data will be used only to evaluate outcomes of patients who had a liver tumour at the time of their liver transplant.

Study Timeline

• Study Start: 2009-11
• Status Verified: 2012-05
• Study First Submitted: 2012-05-24
• Study First Submitted QC: 2012-05-29
• Last Update Submitted: 2012-05-29
• Study First Posted: 2012-05-30
• Last Update Posted: 2012-05-30
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• patients with hepatocellular carcinoma listed for liver transplantation

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-transplant survival	24 months post-transplant

Trial Locations

Locations (1)

University of Alberta; 🇨🇦 Edmonton, Canada