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临床试验/NCT01607788
NCT01607788Unknown不适用

Prospective Database of Liver Transplantation for Hepatocellular Carcinoma

University of Geneva, Switzerland1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2009年11月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
1
主要终点
Post-transplant survival

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with hepatocellular carcinoma listed for liver transplantation

排除标准

  • 未提供

结局指标

主要结局

Post-transplant survival

时间窗: 24 months post-transplant

次要结局

未报告次要终点

研究者

发起方
University of Geneva, Switzerland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christian Toso

Médecin Adjoint Agrégé, University of Geneva

University of Geneva, Switzerland

研究点 (1)

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