Prospective Liver Tumor (ProLiT) Database (ProLit)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by University of Geneva, Switzerland
Sponsor:
Collaborators:
University of Alberta
London Health Sciences Centre
University of Bern
University Hospital, Geneva
Information provided by (Responsible Party):
Christian Toso, University of Geneva, Switzerland
ClinicalTrials.gov Identifier:
NCT01607788
First received: May 24, 2012
Last updated: May 29, 2012
Last verified: May 2012
  Purpose

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.


Condition
Hepatocellular Carcinoma
Evidence of Liver Transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Database of Liver Transplantation for Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by University of Geneva, Switzerland:

Primary Outcome Measures:
  • Post-transplant survival [ Time Frame: 24 months post-transplant ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: November 2009
Estimated Study Completion Date: December 2017
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients with hepatocellular carcinoma listed for liver transplantation at the participating centers

Criteria

Inclusion Criteria:

  • patients with hepatocellular carcinoma listed for liver transplantation
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607788

Contacts
Contact: Norman Kneteman, MD kneteman@ualberta.ca

Locations
Canada
University of Alberta Recruiting
Edmonton, Canada
Contact: Norman Kneteman, MD       kneteman@ualberta.ca   
Principal Investigator: Norman Kneteman, MD         
Sponsors and Collaborators
University of Geneva, Switzerland
University of Alberta
London Health Sciences Centre
University of Bern
University Hospital, Geneva
Investigators
Principal Investigator: Norman Kneteman, MD, PhD University of Geneva
  More Information

No publications provided

Responsible Party: Christian Toso, Médecin Adjoint Agrégé, University of Geneva, University of Geneva, Switzerland
ClinicalTrials.gov Identifier: NCT01607788     History of Changes
Other Study ID Numbers: ProLit
Study First Received: May 24, 2012
Last Updated: May 29, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Geneva, Switzerland:
Selection criteria
Liver transplantation
Hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on September 16, 2014