Clinical trial · Interventional
Biological Characterisation of High Risk CHildhood Cancer in Children, Adolescents and Young Adults (MICCHADO)
Molecular and Immunological Characterisation of High Risk CHildhood Cancer At DiagnOsis, Treatment and Follow-up - Biological Evaluation in Children, Adolescents and Young Adults -
NCT03496402CI-TRIAL-00087353MICCHADOactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Methodology: Prospective, multicentric, open, non-randomised, non-therapeutic, interventional study
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Central Nervous System Tumor | Central Nervous System Neoplasm | ALIAS | 0.90 |
| Ewing Sarcoma Family of Tumors | Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
| Rhabdomyosarcoma | Rhabdomyosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sampling on blood, bone marrow and cerebrospinal fluid | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- High risk Cohorts
- description
- Cohort 1 : High risk Neuroblastoma, High risk Rhabdomyosarcoma, High risk Ewing Sarcoma Family Tumor, High risk Osteosarcoma, High risk Leukaemia (secondary acute myeloid leukaemia or biphenotypic acute leukaemia) Cohort 2 : Extracerebral and cerebral high risk tumor, High risk Leukaemia (leukaemia with high MRD) Sampling on blood, bone marrow and cerebrospinal fluid
- interventionNames
- Other: Sampling on blood, bone marrow and cerebrospinal fluid
- type
- EXPERIMENTAL
- label
- Low risk Cohort
- description
- Cohort 3 : Intermediate or low risk tumors : Neuroblastoma, Rhabdomyosarcoma, Ewing Sarcoma Family Tumor, Osteosarcoma Sampling on blood, bone marrow and cerebrospinal fluid
- interventionNames
- Other: Sampling on blood, bone marrow and cerebrospinal fluid
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 25 Years
Show eligibility criteria text
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 feasibleReferences
Publications (0)
Data not yet available
No reference posted for this study.