NCT03496402进行中（未招募）不适用
Molecular and Immunological Characterisation of High Risk CHildhood Cancer At DiagnOsis, Treatment and Follow-up - Biological Evaluation in Children, Adolescents and Young Adults -
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 试验地点
- 60
- 主要终点
- Number of patients with meaningful immunological features
研究概览
简要总结
Methodology:
Prospective, multicentric, open, non-randomised, non-therapeutic, interventional study
详细描述
To identify and characterise:
- meaningful molecular genetic alterations,
- meaningful immunological features of high risk childhood, adolescents and young adult cancers, at diagnosis, during patient treatment and follow-up (time dimension).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion within 3 months after diagnosis
- •Availability of a cryopreserved tumour sample (primary and/or metastatic and/or lymph nodes) or peripheral blood or bone marrow samples (if invasion more than 30% of lymphoblasts) for leukaemias, obtained at the time of diagnosis during a routine procedure
- •Availability of a formalin-fixed paraffin-embedded (FFPE) tumour sample (primary and/or metastasis and/or lymph nodes), obtained at the time of diagnosis during a routine procedure (except for leukaemia patients)
- •Age: ≤ 25 years at diagnosis
- •Written patient informed consent, or parents or legal representative written informed consent and assent of the child and the adolescent
- •Compulsory affiliation to a social security scheme
- •Additional inclusion criteria for the study:
- •To avoid multiple sampling for children, adolescents and young adults with cancer, patients already included or to be included in a study with similar analyses and/or objectives might also be included in MICCHADO study and in this case, samples or data might be exchanged on a collaborative basis.
- •High risk neuroblastoma:
- •Any type of neuroblastoma with MYCN amplification, except INSS stage 1
- •Stage 4 neuroblastoma in children older than one year at diagnosis
- •High risk rhabdomyosarcoma:
- •Foxo1 rearrangement any stage;
- •and / or N1 ;
- •and / or metastatic rhabdomyosarcoma
- •High risk Ewing sarcoma:
- •Metastatic Ewing sarcoma family of tumours (ESFT)
- •Localised inoperable Ewing sarcoma with primary tumours ≥ 200 ml
- •High risk osteosarcoma:
- •Metastatic osteosarcoma
- •Localised inoperable osteosarcoma
- •High risk leukaemia:
- •Secondary acute myeloid leukaemia
- •Biphenotypic acute leukaemia
- •Extra cerebral or cerebral high risk tumours including:
- •other metastatic sarcomas,
- •other rare high risk cancers,
- •high risk renal tumours with surgery after an initial chemotherapy
- •rhabdoid brain tumours (AT/RT) and extra cerebral rhabdoid tumours
- •high risk or metastatic cancers of unclear histological diagnosis • Lymphoblastic leukaemia with high MRD at Day 78 (time point 2) • Very high risk T-cells acute lymphoblastic leukaemia:
- •MRD ≥ 10-2 at the end of the induction ;
- •or MRD ≥ 10-3 at Day 78
- •Children, adolescents and young adults, with low/intermediate risk cancers belonging to the following types:
- •Neuroblastoma:
- •Localised, without MYCN amplification
- •Localised, INSS stage 1, with MYCN amplification
- •Stage 4s, in infants (younger than one year at diagnosis), without MYCN amplification
- •Rhabdomyosarcoma:
- •Localised, without Foxo1 rearrangement
- •All non-high risk localised ESFT • Osteosarcoma:
- •All non-high risk localised osteosarcoma
排除标准
- •Main non-inclusion Criteria common to all study cohorts:
- •Age: patients > 25 years old at diagnosis 2) Absence of patient or parents or legal representative written informed consent 3) Patient for whom follow-up by the investigating centre does not appear feasible
结局指标
主要结局
Number of patients with meaningful immunological features
时间窗: At the end of study (6 years)
Identification and characterisation of the tumor microenvironment and the host's immunological profile, at diagnosis and during patient treatment
Number of patients with meaningful molecular genetic alterations
时间窗: At the end of study (6 years)
Identification of molecular genetic alterations based on molecular characterisation of tumor at diagnosis, during patient treatment and follow-up (time dimension)
Number of patients with identification of new tumor-specific genetic characteristics during follow-up (clonal evolution)
时间窗: up to 6 years
Comparison between genetic variations identified at diagnosis and those identified on circulating tumor DNA during treatment, FU and/or relapse
次要结局
- Correlation between disease staging and immunological features(up to 6 years)
- Correlation between genetic variations and immune parameters(up to 6 years)
- Correlation between disease recurrence and molecular and/or immunological biomarkers(up to 6 years)
研究者
研究点 (60)
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