Biological Characterisation of High Risk CHildhood Cancer in Children, Adolescents and Young Adults (MICCHADO)

Launched by INSTITUT CURIE · Apr 5, 2018

Keywords

ClinConnect Summary

The MICCHADO trial is a research study aimed at understanding high-risk childhood cancers, such as neuroblastoma, rhabdomyosarcoma, Ewing sarcoma, osteosarcoma, leukemia, and central nervous system tumors. This trial is looking for children, adolescents, and young adults aged 25 or younger who have been diagnosed with these cancers within the last three months. To participate, patients need to have certain types of tumor samples available from their diagnosis, along with consent from themselves or their parents.

Participants in this study can expect to provide samples of their tumors or blood, which will help researchers learn more about these aggressive cancers and potentially improve future treatments. Since this is a non-therapeutic study, participants will not receive new treatments as part of the trial, but their contributions will play a crucial role in advancing our understanding of these diseases. If you or someone you know might be eligible, it's a good idea to discuss it with a healthcare provider for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Inclusion within 3 months after diagnosis
• • 2. 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
• • 3. 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)
• • 4. Age: ≤ 25 years at diagnosis
• • 5. Written patient informed consent, or parents or legal representative written informed consent and assent of the child and the adolescent
• • 6. 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.
• Cohort 1:
• * 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
• Cohort 2:
• • 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
• Cohort 3:
• 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
• • ESFT:
• * All non-high risk localised ESFT • Osteosarcoma:
• • All non-high risk localised osteosarcoma
• Exclusion Criteria:
• Main non-inclusion Criteria common to all study cohorts:
• • 1) 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