Biological Characterisation of High Risk CHildhood Cancer in Children, Adolescents and Young Adults (MICCHADO)
MICCHADO
Molecular and Immunological Characterisation of High Risk CHildhood Cancer At DiagnOsis, Treatment and Follow-up - Biological Evaluation in Children, Adolescents and Young Adults -
1 other identifier
interventional
600
1 country
30
Brief Summary
Methodology: Prospective, multicentric, open, non-randomised, non-therapeutic, interventional study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2018
Longer than P75 for not_applicable
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2018
CompletedFirst Posted
Study publicly available on registry
April 12, 2018
CompletedStudy Start
First participant enrolled
April 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 19, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 19, 2027
March 18, 2025
March 1, 2025
9 years
February 26, 2018
March 14, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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)
At the end of study (6 years)
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
At the end of study (6 years)
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
up to 6 years
Secondary Outcomes (3)
Correlation between disease recurrence and molecular and/or immunological biomarkers
up to 6 years
Correlation between genetic variations and immune parameters
up to 6 years
Correlation between disease staging and immunological features
up to 6 years
Study Arms (2)
High risk Cohorts
EXPERIMENTALCohort 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
Low risk Cohort
EXPERIMENTALCohort 3 : Intermediate or low risk tumors : Neuroblastoma, Rhabdomyosarcoma, Ewing Sarcoma Family Tumor, Osteosarcoma Sampling on blood, bone marrow and cerebrospinal fluid
Interventions
biological sampling during treatment and follow-up
Eligibility Criteria
You may qualify if:
- 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
- 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:
- +28 more criteria
You may not qualify if:
- \) 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Curielead
Study Sites (30)
Chu D'Amiens Picardie
Amiens, 80054, France
CHU Angers
Angers, 49933, France
CHRU de Besançon - Hôpital Jean-Minjoz
Besançon, 25030, France
CHU de Bordeaux - Hôpital des enfants - Groupe Hospitalier Pellegrin
Bordeaux, 33076, France
CHRU de Brest
Brest, 29609, France
CHU CAEN
Caen, 14033, France
Centre Régional de Cancérologie et Thrapie Cellulaire Pdiatrique (CRCTCP)
Clermont-Ferrand, 63003, France
CHU Hôpital d'Enfants
Dijon, 21079, France
CHU GRENOBLE Alpes - Hôpital Couple-Enfant
Grenoble, 38043, France
Centre Oscar Lambret
Lille, 59020, France
CHU de Limoges - Hôpital Mère-Enfant
Limoges, 87042, France
Centre Léon Bérard
Lyon, 69373, France
Hospices Civils de Lyon
Lyon, 69373, France
Hôpital d'Enfants de la Timone (AP-HM)
Marseille, 13385, France
CHU Arnaud de Villeneuve
Montpellier, 34295, France
CHU Nantes - Hôpital Mère Enfant
Nantes, 44093, France
Hôpital l'Archet 2
Nice, BP 3079, France
Hôpital d'Enfants Armand-Trousseau
Paris, 75012, France
Hôpital universitaire Robert-Debré (AP-HP)
Paris, 75019, France
Institut Curie
Paris, 750248, France
CHU de Poitiers
Poitiers, 86021, France
CHU de Reims - Hôpital Américain
Reims, 51100, France
Chu Hopital Sud Rennes
Rennes, 35056, France
CHU de Rouen - Hôp. Charles NICOLLE
Rouen, 76031, France
CHU Saint-Etienne - Hôpital Nord
Saint-Etienne, 42055, France
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
Strasbourg, 67098, France
CHU Hôpital des Enfants
Toulouse, 31059, France
CHU TOURS - Hôpital Clocheville
Tours, 37044, France
CHU Nancy - Hôpital d'Enfants
Vandœuvre-lès-Nancy, 54500, France
Gustave Roussy
Villejuif, 94805, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gudrun SCHLEIERMACHER, MD
Institut Curie
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2018
First Posted
April 12, 2018
Study Start
April 20, 2018
Primary Completion (Estimated)
April 19, 2027
Study Completion (Estimated)
August 19, 2027
Last Updated
March 18, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share