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临床试验/NCT03908502
NCT03908502招募中不适用

An Observational Study in Clinical Manifestations, Therapeutic Effects, Progress, and Prognosis of Radiotherapy-related Nervous System Complications

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
4,000
试验地点
1
主要终点
Overall Survival (OS)

研究概览

简要总结

Purpose: This observational study aims to evaluate the clinical manifestations, therapeutic effects, progress and prognosis in radiotherapy-related nervous system complications.

OUTLINE: This is an observational clinical trial. Patients are enrolled and administrated with optimized clinical treatment. Blood, urine, stool, cerebrospinal fluid (CSF), imaging and other examinations, and scale assessments are regularly performed to evaluate the state of the disease.

Further study details are provided by Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University/Yamei Tang.

Primary outcome measure: The primary endpoint is overall survival.

详细描述

BACKGROUND

Radiotherapy is a key component in the management of head and neck tumors and primary or metastatic cancer of the central nervous system. Various radiation treatment methods employ different types of fractionation and conformational protocols designed to deliver focused radiation to target regions to maximize the lethal effect on the neoplasm and minimize the extraneous dose on normal brain tissue and other adjacent organs at risk. The outcomes of these clinical protocols may be complicated by radiation effects on normal brain parenchyma and other nervous system, resulting in a spectrum of phenotypes that range from clinically asymptomatic changes to radiotherapy-related nervous system complications with severe neurological defects, including delayed radiation-induced brain necrosis, myelopathy and nerve injury.

STUDY DESIGN:

Interventions Patients are enrolled and administrated with optimized clinical treatment.

Follow-up examinations

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Overall Survival (OS)

时间窗: Baseline until death or up to Year 20

Overall survival is the duration between the first day of study enrollment to death. For participants who are alive, overall survival is censored at the last contact.

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

Yamei Tang

Professor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

研究点 (1)

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