ClinicalTrials.gg
Active, not recruitingNCT03496402MICCHADOUpdated Mar 18, 2025

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

An interventional study of Sampling on blood, bone marrow and cerebrospinal fluid in Neuroblastoma, Rhabdomyosarcoma and Ewing Sarcoma Family of Tumors, sponsored by Institut Curie. Active, not recruiting at 30 sites in France. Open to participants aged 1 Year to 25 Years. Per ClinicalTrials.gov, last updated 2025-03-18.

Sponsored by Institut Curie · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Non-randomized
Ages
1 Year to 25 Years
Sex
All
01

Study summary

Methodology:

Prospective, multicentric, open, non-randomised, non-therapeutic, interventional study

Read the detailed description

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).
02

Conditions studied

  • Neuroblastoma
  • Rhabdomyosarcoma
  • Ewing Sarcoma Family of Tumors
  • Osteosarcoma
  • Leukemia
  • Central Nervous System Tumor
03

In context

Neuroblastoma

675 studies on the registry are indexed under Neuroblastoma; 127 are open to participants now.

This study's planned enrollment of 600 is above the median of 32 across 507 interventional studies indexed under Neuroblastoma.

Browse Neuroblastoma studies →

Lead sponsor

Institut Curie is the lead sponsor of 135 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  1. Inclusion within 3 months after diagnosis
  2. Availability of a cryopreserved tumour sample (primary and/or 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 , 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    High risk Cohorts

    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

    Other: Sampling on blood, bone marrow and cerebrospinal fluid

  • Experimental
    Low risk Cohort

    Cohort 3 : Intermediate or low risk tumors : Neuroblastoma, Rhabdomyosarcoma, Ewing Sarcoma Family Tumor, Osteosarcoma Sampling on blood, bone marrow and cerebrospinal fluid

    Other: Sampling on blood, bone marrow and cerebrospinal fluid

Interventions

  • OtherSampling on blood, bone marrow and cerebrospinal fluid

    biological sampling during treatment and follow-up

06

What researchers measure

Primary outcomes

  1. Number of patients with meaningful molecular genetic alterations

    Identification of molecular genetic alterations based on molecular characterisation of tumor at diagnosis, during patient treatment and follow-up (time dimension)

    Time frame: At the end of study (6 years)

  2. Number of patients with meaningful immunological features

    Identification and characterisation of the tumor microenvironment and the host's immunological profile, at diagnosis and during patient treatment

    Time frame: At the end of study (6 years)

  3. Number of patients with identification of new tumor-specific genetic characteristics during follow-up (clonal evolution)

    Comparison between genetic variations identified at diagnosis and those identified on circulating tumor DNA during treatment, FU and/or relapse

    Time frame: up to 6 years

Secondary outcomes

  1. Correlation between disease recurrence and molecular and/or immunological biomarkers

    To characterise biomarkers, based on molecular analyses of tumour samples from diagnosis, for prognostic and predictive purposes. To characterise the tumour microenvironment and the host's immunological profile, for prognostic and predictive purposes. To identify potential prognostic and predictive biomarkers on samples collected during patient's treatment and follow-up, based on changes on circulating tumour DNA (ctDNA), detected by molecular biology techniques, and on immunological findings

    Time frame: up to 6 years

  2. Correlation between genetic variations and immune parameters

    To compare molecular and immunological findings at diagnosis and during treatment (data integration)

    Time frame: up to 6 years

  3. Correlation between disease staging and immunological features

    To investigate the impact of the tumour microenvironment and host's immunological profile on the disease staging at diagnosis, by comparing patients with metastatic to patients with localised disease

    Time frame: up to 6 years

07

Study locations

30 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2018 (actual). Primary completion is estimated for Apr 2027, 107 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 26, 2018
First posted
Apr 12, 2018
StartActual
Apr 20, 2018
Primary completionEst.
Apr 19, 2027
CompletionEst.
Aug 19, 2027
Last update
Mar 18, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03496402
Lead sponsor
Institut Curie
Responsible party
Sponsor
First posted
Apr 12, 2018
Start date
Apr 20, 2018
Primary completion
Apr 19, 2027 (estimated)
Completion
Aug 19, 2027 (estimated)
Last update
Mar 18, 2025

Study contacts

Gudrun SCHLEIERMACHER, MD
principal investigator · Institut Curie

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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