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NeuroblastomaMICCHADONCT03496402

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

A study testing Sampling on blood, bone marrow and cerebrospinal fluid in people with Neuroblastoma and Rhabdomyosarcoma, run by Institut Curie at 30 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Methodology: Prospective, multicentric, open, non-randomised, non-therapeutic, interventional study Read more about this study

Who is it for?
Ages 1 year to 25 years
What is being tested?
Sampling on blood, bone marrow and cerebrospinal fluid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
30 sitesFrance
Study dates
20 Apr 2018to 19 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
Show all 45Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

France30 sites

  • Chu D'Amiens Picardie

    Amiens, 80054

  • CHU Angers

    Angers, 49933

  • CHRU de Besançon - Hôpital Jean-Minjoz

    Besançon, 25030

  • CHU de Bordeaux - Hôpital des enfants - Groupe Hospitalier Pellegrin

    Bordeaux, 33076

  • CHRU de Brest

    Brest, 29609

  • CHU CAEN

    Caen, 14033

  • Centre Régional de Cancérologie et Thrapie Cellulaire Pdiatrique (CRCTCP)

    Clermont-Ferrand, 63003

  • CHU Hôpital d'Enfants

    Dijon, 21079

  • CHU GRENOBLE Alpes - Hôpital Couple-Enfant

    Grenoble, 38043

  • Centre Oscar Lambret

    Lille, 59020

  • CHU de Limoges - Hôpital Mère-Enfant

    Limoges, 87042

  • Centre Léon Bérard

    Lyon, 69373

  • Hospices Civils de Lyon

    Lyon, 69373

  • Hôpital d'Enfants de la Timone (AP-HM)

    Marseille, 13385

  • CHU Arnaud de Villeneuve

    Montpellier, 34295

  • CHU Nantes - Hôpital Mère Enfant

    Nantes, 44093

  • Hôpital l'Archet 2

    Nice, BP 3079

  • Hôpital d'Enfants Armand-Trousseau

    Paris, 75012

  • Hôpital universitaire Robert-Debré (AP-HP)

    Paris, 75019

  • Institut Curie

    Paris, 750248

  • CHU de Poitiers

    Poitiers, 86021

  • CHU de Reims - Hôpital Américain

    Reims, 51100

  • Chu Hopital Sud Rennes

    Rennes, 35056

  • CHU de Rouen - Hôp. Charles NICOLLE

    Rouen, 76031

  • CHU Saint-Etienne - Hôpital Nord

    Saint-Etienne, 42055

  • Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

    Strasbourg, 67098

  • CHU Hôpital des Enfants

    Toulouse, 31059

  • CHU TOURS - Hôpital Clocheville

    Tours, 37044

  • CHU Nancy - Hôpital d'Enfants

    Vandœuvre-lès-Nancy, 54500

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: Molecular and Immunological Characterisation of High Risk CHildhood Cancer At DiagnOsis, Treatment and Follow-up - Biological Evaluation in Children, Adolescents and Young Adults -

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).
Being tested
Sampling on blood, bone marrow and cerebrospinal fluid
Medical subject headings
Neuroblastoma, Rhabdomyosarcoma, Neuroectodermal Tumors, Primitive, Peripheral, Osteosarcoma, Leukemia, Central Nervous System Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sampling on blood, bone marrow and cerebrospinal fluidOther

    biological sampling during treatment and follow-up

Study groups in NCT03496402
Study groupRoleWhat they receive
High risk CohortsExperimentalCohort 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
Receives: Other: Sampling on blood, bone marrow and cerebrospinal fluid
Low risk CohortExperimentalCohort 3 : Intermediate or low risk tumors : Neuroblastoma, Rhabdomyosarcoma, Ewing Sarcoma Family Tumor, Osteosarcoma Sampling on blood, bone marrow and cerebrospinal fluid
Receives: Other: Sampling on blood, bone marrow and cerebrospinal fluid

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 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

    Measured: 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

    Measured: up to 6 years

Secondary outcomes (3)

  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

    Measured: 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)

    Measured: 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

    Measured: up to 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2018
  2. Study start20 Apr 2018
  3. Primary completion19 Apr 2027 (estimated)
  4. Study completion19 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03496402
Sponsor's protocol ID
IC 2017-02
Acronym
MICCHADO
Status last verified
Mar 2025
First submitted
26 Feb 2018
Last updated
18 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Sampling on blood, bone marrow and cerebrospinal fluid in people with Neuroblastoma and Rhabdomyosarcoma, run by Institut Curie at 30 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 45 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with meaningful molecular genetic alterations (time frame: At the end of study (6 years)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03496402.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.

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