Clinical trial NCT01607788: Prospective Liver Tumor (ProLiT) Database
Official title: Prospective Database of Liver Transplantation for Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Evidence of Liver Transplantation
Keywords: Selection criteria
Liver transplantation
Hepatocellular carcinoma
Lead sponsor: University of Geneva, Switzerland
Sponsor class: OTHER
Collaborators: name: University of Alberta
name: London Health Sciences Centre
name: University of Bern
name: University Hospital, Geneva
First posted: 2012-05-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with hepatocellular carcinoma listed for liver transplantation at the participating centers

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.

Eligibility criteria: Inclusion Criteria:

* patients with hepatocellular carcinoma listed for liver transplantation

Primary outcomes:
measure: Post-transplant survival
timeFrame: 24 months post-transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
Study officials:
affiliation: University of Geneva
name: Norman Kneteman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: