Rare Tumours in Children and Adolescents (STEP 2.0) - Register for the Documentation of Rare Tumours in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Event-free survival
研究概览
简要总结
The aim of the STEP registry is to collect and evaluate experience and data on the diagnosis and treatment of rare childhood tumors in order to use the knowledge gained to improve the treatment prospects for our patients. The rarity of a disease should not be a disadvantage for the young patients.
详细描述
The objective of the STEP registry is to optimise the diagnosis and treatment of patients with rare tumour diseases in childhood and adolescence. Therefore, a continuous prospective collection of clinical data on rare paediatric tumours is conducted to improve the understanding of these tumours. Beyond analysis of clinical data, further scientific research on the biological and molecular genetic characteristics of these tumours is performed. These data and a close collaboration with international partners, especially the European EXPeRT group, enable the improvement of treatment recommendations for these tumours along with establishment a global interdisciplinary network of rare tumour specialists.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a rare solid tumor
- •Age at diagnosis: Neonatal period to 18 years (In the case of young adults, registration in the database and/or referral to advisory contact persons within the framework of the competence network can take place upon request and after declaration of consent.)
- •Information, education, written consent of the patient or the guardian
- •Not recorded in any of the existing clinical studies/ registers of the German Society for Pediatric Oncology and Hematology (GPOH)
排除标准
- •Registration of the tumor diagnosis in a prospective therapy study/ another clinical registry of the GPOH
- •Lack of information, explanation and/or written consent of the patient or the legal guardian.
结局指标
主要结局
Event-free survival
时间窗: 5 years
Period between study entry and failure of induction therapy, recurrence or death from any cause is measured.
次要结局
未报告次要终点