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临床试验/NCT05028270
NCT05028270Unknown不适用

Clinical Study of Superselective Ophthalmic Artery Interventional Chemotherapy for Intraocular Retinoblastoma

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine0 个研究点目标入组 1,600 人开始时间: 2022年6月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,600
主要终点
Overall success rate

研究概览

简要总结

This study compares the effects of balloon technology and microcatheter technology on the eye protection rate of neuroblastoma

详细描述

Retinoblastoma is the most common intraocular malignant tumor in childhood, with an incidence of about 1/15,000-20,000, accounting for 4% of all childhood cancers. All patients with bilateral reticuloblastoma and approximately 10%-15% of children with unilateral disease have germline mutations that can be passed on to their offspring.In developed countries, the survival rate is close to 98%. However, due to the limitations of health care in low-income countries, this proportion is much lower, about 40%. Before the 1990s, retinoblastoma was mainly treated with enucleation and external beam radiation therapy (EBRT). However, these methods are associated with many complications, including vision loss and serious side effects. At present, the first-line conservative treatment of retinoblastoma has changed from EBRT and enucleation to Intravenous chemotherapy (IVC) or intra-arterial chemotherapy (IAC), and it has been consolidated through focal treatment. There are two different surgical procedures for intra-arterial chemotherapy, namely balloon technique and microcatheter technique. Investigators observe their effects through a retrospective case-control study.

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

入选标准

  • 1 year old <age ≤ 18 years old;
  • After biopsy, histopathology and immunohistochemistry tests refer to the COG recommended neuroblastoma diagnostic criteria, pathological classification (INPC), and international neuroblastoma staging (INSS)
  • Patients who were diagnosed with RB for the first time or received chemotherapy in our hospital for the first time after diagnosis
  • ECOG scale (ECOG-PS) ≤ 2;

排除标准

  • No antibiotics and no gastrointestinal surgery within 3 months.
  • Patients with autoimmune diseases;
  • Patients with immunodeficiency;
  • Patients who have been treated for relapsed/refractory diseases; relapsed NB is the appearance of new lesions at the primary site or other sites 4 weeks after the multidisciplinary comprehensive treatment reaches CR. Refractory NB is defined as induced by 2 to 4 courses of treatment The post-effect evaluation is progression disease (PD) during chemotherapy;
  • Multiple organ failure;
  • Uncontrolled infection and diarrhea

结局指标

主要结局

Overall success rate

时间窗: 1 year

To evaluate the 1-year ocular salvage rate in the treatment of retinoblastoma \[ Time Frame: 1 year \] 12-month ocular salvage rate: calculate the number and percentage of subjects who reach 12-month ocular salvage rate, and use the exact probability method to estimate 95% CI.

Second tumor rate

时间窗: 1 year

To evaluate the 1-year recurrence of the tumor.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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