EUCTR2010-021396-81-IE进行中（未招募）1 期
European Low and Intermediate Risk Neuroblastoma - LINES
INSTITUTO DE INVESTIGACIÓN SANITARIA LA FE DE0 个研究点目标入组 550 人开始时间: 2014年6月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 550
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •INTERMEDIATE-ALL GROUPS: informed consent and follow-up warranted, group assignment completed within 6 weeks from diagnosis, no prior chemotherapy or radiotherapy,Tumour material available for biological studies according to guidelines,Biopsy proven neuroblastoma confirmed in a NRL. INRG STAGE L1 AND INSS STAGE 1: MYCN amplified. INRG STAGE L2: Histology: differentiating, poorly differentiated, undifferentiated neuroblastoma or ganglioneuroblastoma nodular; MYCNnon-amplified;age >18 months. INRG STAGE M: Any histology;MYCN non-amplified;age = 12 months.
- •LOW RISK- ALL GROUPS: informed consent and follow-up warranted; group assignment completed within 6 weeks from diagnosis; no prior
- •chemotherapy or radiotherapy, Biopsy proven neuroblastoma,Tumour genomic profile obtained in a NRL according to guidelines, MYCNnonamplified. INRG STAGE L2: age = 18 months. INRG STAGE MS: age = 12 months.
- •NAM: Age less than or equal to 90 days when the suprarenal mass is discovered, Suprarenal mass detected by ultrasound and/or MRI. The suprarenal mass may be cystic and/or solid, but it cannot reach the midline and should measure = 5 cm at the largest diameter, No regional involvement: MRI scan does not show evidence of positive ipsi/contralateral lymph nodes or other spread outside the suprarenal gland, No metastatic involvement, Frozen plasma available,Informed consent, Availability to do the adequate follow-up.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 557
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •INTERMEDIATE- ALL GROUPS: diagnosis of ganglioneuroma or ganglioneuroblastoma intermixed. INRG STAGE L1 AND INSS STAGE 1: MYCNnon-amplified, INSS stages 2, 3, 4, 4s. INRG STAGE L2: neuroblastoma NOS, MYCN amplification;age = 18 months. INRG STAGE M: MYCN amplification, age > 12 months.
- •LOW RISK- ALL GROUPS: Diagnosis of ganglioneuroma or ganglioneuroblastoma intermixed. INRG STAGE L2: any metastatic site, MYCN amplification, age > 18 months. INRG STAGE MS: bone, pleura/lung and/or CNS metastasis, MYCN amplification, age > 12
- •NAM: Age older than 90 days, Suprarenal mass bigger than 5 cm, Regional involvement, Metastatic involvement, Inability to undertake mandatory diagnostic studies (biological markers, US, MRI, MIBG), Follow-up not guaranteed by parents/guardians.
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