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临床试验/NCT02557750
NCT02557750招募中不适用

Combined Modality Therapy in Hepatoblastoma: South Egypt Cancer Institute Experience

Assiut University1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
35
试验地点
1
主要终点
Overall survival (OS)

研究概览

简要总结

The aim of this study is to retrospectively investigate the effect of combined modality treatment of pediatric hepatoblastoma and the factors affecting the prognosis in accordance with the experience at the pediatric oncology department at South Egypt Cancer Institute.

详细描述

Background:

Hepatoblastoma (HB) is the most common malignant liver tumor in children, with an incidence of 0.7 to 1 per million children <15 years of age. Till 1970s, surgery was the primary modality of treatment of HB. Unfortunately, up to 60% of the patients present in an unresectable stage. Later, the chemo- responsiveness of the tumor was demonstrated which led to the incorporation of adjuvant chemotherapy with cisplatinum and doxorubicin in the treatment of HB. International Society of Pediatric Oncology (SIOP) pioneered the concept of neoadjuvant chemotherapy in the management of HB.

Patients & Methods:

In the period from 2002 January till 2016 January, retrieval & analysis of the medical records of pediatric patients with hepatoblastoma will be made at the pediatric oncology department, South Egypt Cancer Institute which represents the largest referral center in Upper Egypt. After pathologic confirmation of the diagnosis, these data will be categorized according to patients' demographics, presenting features, laboratory studies, including tumor markers & histologic subtype, radiographic evaluation, disease staging, treatment course given, and subsequent treatment outcomes.

研究设计

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

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

  • Patients whose age less than 19 years.
  • Patients diagnosed with hepatoblastoma.

排除标准

  • Patients whose age more than 18 years.

结局指标

主要结局

Overall survival (OS)

时间窗: Participants will be retrospectively followed forward in time from the date of initiation of treatment till the primary completion date of the study, an expected average of 5 years

Time from the date of initiation of treatment until death from any cause

Event Free Survival (EFS)

时间窗: Participants will be retrospectively followed forward in time from the date of initiation of treatment till the primary completion date of the study, an expected average of 5 years

Time from the date of initiation of treatment until disease progression, or death for any reason.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mohammed Morsy, MD

Lecturer, Pediatric Oncology Department

Assiut University

研究点 (1)

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