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临床试验/NCT03467295
NCT03467295Unknown不适用

Treatments and Outcomes of Untreated Cerebral Cavernous Malformations in CHINA (TOUCH): A Nationwide Multicenter Prospective Cohort Study.

First Affiliated Hospital of Fujian Medical University1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,000
试验地点
1
主要终点
Poor outcome

研究概览

简要总结

This nationwide multicenter prospective cohort study will collect the treatment information and outcomes of the patients with previously untreated cavernous malformations (U-CMs) in China (at least 2000 patients from 20 centers). The investigators aim to determine the effect of different treatments on long-term outcomes in patients with untreated cerebral cavernous malformations.

详细描述

Despite the availability of microsurgical excision and stereotactic radiosurgery for cavernoma treatment and known genetic causes of most familial forms of cavernoma, uncertainties remain about cause, diagnosis, prognosis, treatment, and care. According to the recently published CM treatment guideline, surgical and conservative treatments are both first-line therapeutic options in previously untreated CMs (U-CMs). However, given current data, neurosurgeons are still unable to counsel patients on which would be the best option. To address the absence of high level evidence to support cerebral CM treatment decisions, there is a need for a large sample size study of cerebral CM treatment with a prospective concurrent group. China has the largest population in the world and may have the most extensive and valuable clinical resources of U-CMs. But, till now, the current treatment and outcome situation of the disease in China is not well known. Thus, the investigators are conducting a nationwide multicenter prospective registry study in China to determine the effect of different treatments on long-term outcomes in patients with untreated cerebral cavernous malformations.At least 2000 patients with untreated cerebral cavernous malformation will be enrolled from 20 Grade Ⅲ A level hospitals distributed all over China. Clinical data and laboratory data are prospectively collected by electric case report form (CRF) and uploaded online by each neurosurgery center to form the prospective clinical database in First Affiliated Hospital of Fujian Medical University. This is a cohort follow-up study across a 5-year period with a 2 years interval of enrollment and 3 years follow up for each patient.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Definite diagnosis of cerebral CM on the basis of brain MRI or pathologic examination;
  • Patients without any surgical intervention (microsurgery, radiosurgery, or multimodality treatment) before enrolment;
  • Informed consent, and willing to accept long-term follow-up.

排除标准

  • Patients receiving emergency surgery due to acute intracranial hematoma and resultant brain hernia;
  • Patients with other never system diseases, such as aneurysms, tumors or other vascular malformations except venous development anomaly;
  • Patients with severe underlying disease, which affects the patient's functional status and life expectancy;
  • Patients with severe mental or psychologic disease.

结局指标

主要结局

Poor outcome

时间窗: 3 years

The primary outcome of this study is patients with poor outcome (mRS\>2 lasting at least 1year) at the last follow up.

次要结局

  • symptomatic hemorrhage(3 years)
  • drug refractory epilepsy(3 years)
  • All-cause mortality(3 years)

研究者

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

Fuxin Lin

Principal Investigator

First Affiliated Hospital of Fujian Medical University

研究点 (1)

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