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临床试验/NCT04425434
NCT04425434招募中不适用

Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma

French Africa Pediatric Oncology Group9 个研究点 分布在 6 个国家目标入组 3,000 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
3,000
试验地点
9
主要终点
Evaluating the treatment given.

研究概览

简要总结

As the survival of children with retinoblastoma in high income countries is higher than 95% including the bilateral forms this study hopes to improve the outcome in low income countries in Africa by improving early diagnosis and early implementation of this protocol of therapeutic recommendations for treatment.

详细描述

In this study we will try to improve the outcome for children with stage II disease. It is hoped that we will be able to show that with early intervention correct early diagnosis the survival of these children is greatly improved. The collection of data in this observational study will allow us to show this improvement, by analysis of stage, treatment and outcome.

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

  • Unilateral intraocular Retinoblastoma (RB)
  • Unilateral extraocular intraorbital (RB)
  • Bilateral intraocular (RB)
  • bilateral intraocular (RB) on one side and extraocular but intraorbital on the other side.

排除标准

  • Externalized tumor mass
  • massive extension to optic nerve up to optical channeltumor
  • intracranial extension leptomeninges
  • cerebral parenchyma
  • extension to regional lymph nodes and/or remote metastases.
  • cerebrospinal fluid involvement.
  • Trilateral RB
  • Incapacity to followed the whole treatement.

结局指标

主要结局

Evaluating the treatment given.

时间窗: 10 years

Comparison of treatment given and recommended treatment.

follow up

时间窗: 10 years

analysis of the number of children alive or dead after treatment

Feasibility of these therapeutic recommendations in an African setting

时间窗: 10 years

Evaluate the application of these therapeutic recommendations

Number of cases with retinoblastoma in each participating hospital.

时间窗: 10 years

Evaluation of the number of cases registered .

Number of cases with stage 2 disease

时间窗: 10 years

Evaluation of the number of cases registered with stage 2 disease.

次要结局

未报告次要终点

研究者

发起方
French Africa Pediatric Oncology Group
申办方类型
Other
责任方
Sponsor

研究点 (9)

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