跳至主要内容
临床试验/NCT01991652
NCT01991652招募中不适用

Collaborative Wilms Tumour Africa Project

Amsterdam UMC, location VUmc3 个研究点 分布在 3 个国家目标入组 400 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
3
主要终点
Event free survival

研究概览

简要总结

Significant progress has been made in the treatment of Wilms tumor in high income countries, where survival is now around 85% - 90%. Survival in low income countries is much lower; specific challenges include late presentation, malnutrition, less intense supportive care facilities and failure to complete treatment.

A comprehensive treatment guideline was introduced in Malawi in 2006 which included nutritional support and social support to enable parents to complete treatment. Survival has increased to around 50%; 95% of children completed their treatment. A multi-disciplinary group of African clinicians and 'state of the art' experts produced a consensus treatment guideline for children with Wilms tumor in sub-Saharan Africa. This guideline will be implemented as a multi-center prospective clinical trial in 2014 in six - eight institutes, expecting about 200 new patients per year.

The hypothesis is that 2 year event free survival will be 50%, with <10% failure to complete treatment and <10% treatment related mortality. Other research questions include efficacy and toxicity of preoperative chemotherapy and the comparison of surgical staging, local pathology and central review pathology in stratifying postoperative chemotherapy.

详细描述

Patients are treated according to standard care. Data are documented on presentation at diagnosis, response of the tumor, findings at surgery and pathology, treatment given and outcome of the patients.

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
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age < 18 years
  • Diagnosis Wilms tumour

排除标准

  • 未提供

结局指标

主要结局

Event free survival

时间窗: 2 years

Percentage of patients with no event after two years of follow up.

次要结局

未报告次要终点

研究者

发起方
Amsterdam UMC, location VUmc
申办方类型
Other
责任方
Principal Investigator
主要研究者

Trijn Israels

Paediatric Oncologist, MD PhD

Amsterdam UMC, location VUmc

研究点 (3)

Loading locations...

相似试验