DRKS00007623招募中不适用
INFORM Registry INdividualized Therapy FOr Relapsed Malignancies in Childhood - INFORM
Deutsches Krebsforschungszentrum / Universitätsklinikum Heidelberg0 个研究点目标入组 10,000 人开始时间: 2014年12月18日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- one 至 40 Years（—）
- 性别
- All
入选标准
- •Children, adolescents and young adults 0-40 years old with refractory/relapsed/progressive oncological disease following first, second or third line treatment protocols including targeted treatment approaches considering entity-specific high-risk criteria. High-grade gliomas (incl. DIPG), specific soft tissue sarcomas, ETMR and rare tumor diseases included in the STEP Registry, e.g. carcinoma, melanoma, rare gonadal tumors or in the MET Registry, e.g. ACC, ACx, PCC/PGL by SDHB or metastases, MTC, NETs except appendix may be enrolled upon primary diagnosis
- •Patients can be included up until the age of 40 years, but they must have had their primary diagnosis below the age of 21 years
- •No established curative treatment options
- •Life expectancy > 3 months and sufficient general condition (Lansky = 50 or Karnofsky = 50)
- •Patient treated in Germany or in one of the partner countries
- •First-line treatment within one of the therapy optimization/registry trials of the Society of Pediatric Oncology and Hematology (GPOH) or an equivalent protocol, except for primary diagnosis high-grade gliomas (incl. DIPG), specific primary soft tissue sarcomas, ETMR, rare tumor diseases included in the STEP Registry or malignant endocrine tumors included in the MET Registry.
- •Inclusion in INFORM Registry discussed with and agreed by respective GPOH entity study group (or the respective National Coordinator).
- •Histopathological/molecular confirmation of clinically suspected diagnosis (result/confirmation does not have to be available at the time of registration).
- •Routine surgery/puncture of the current oncological disease as part of standard of care treatment.
- •Time between surgery/puncture of the current oncological disease and receipt of all required samples and information in the INFORM Incoming / Sample Processing Laboratory at the CCU Neuropathology in Heidelberg = 8 weeks.
- •For German patients with solid tumors and brain tumors suitable fresh frozen tumor tissue of the current disease episode and non-malignant germline material available (to be sent to INFORM Registry for molecular analysis). For all international patients (and German patients with non-solid tumors) already extracted tumor DNA and tumor RNA from fresh frozen malignant material of the current disease episode as well as DNA from non-malignant germline material available (to be sent to INFORM Registry for molecular analysis).
- •Tumor cell content / tumor infiltration / blast content in submitted tumor material has to be at least 40% (in case of non-solid tumors at least 30%).
- •Written informed consent of patients and/or legal guardians.
排除标准
- •Acute promyelocytic leukemia.
- •Acute myeloid leukemia in patients with Down Syndrome.
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