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

NCT ID: NCT03496402

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-20
• Study Completion Date: 2027-08-19

Brief Summary

Methodology:

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

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).

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Sampling on blood, bone marrow and cerebrospinal fluid

Intervention Type: OTHER

biological sampling during treatment and follow-up

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

Group Type: EXPERIMENTAL

Sampling on blood, bone marrow and cerebrospinal fluid

Intervention Type: OTHER

biological sampling during treatment and follow-up

Interventions

Sampling on blood, bone marrow and cerebrospinal fluid

biological sampling during treatment and follow-up

Intervention Type: OTHER

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

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

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Curie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gudrun SCHLEIERMACHER, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Curie

Locations

Chu D'Amiens Picardie

Amiens, , France

CHU Angers

Angers, , France

CHRU de Besançon - Hôpital Jean-Minjoz

Besançon, , France

CHU de Bordeaux - Hôpital des enfants - Groupe Hospitalier Pellegrin

Bordeaux, , France

CHRU de Brest

Brest, , France

CHU CAEN

Caen, , France

Centre Régional de Cancérologie et Thrapie Cellulaire Pdiatrique (CRCTCP)

Clermont-Ferrand, , France

CHU Hôpital d'Enfants

Dijon, , France

CHU GRENOBLE Alpes - Hôpital Couple-Enfant

Grenoble, , France

Centre Oscar Lambret

Lille, , France

CHU de Limoges - Hôpital Mère-Enfant

Limoges, , France

Centre Léon Bérard

Lyon, , France

Hospices Civils de Lyon

Lyon, , France

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

Marseille, , France

CHU Arnaud de Villeneuve

Montpellier, , France

CHU Nantes - Hôpital Mère Enfant

Nantes, , France

Hôpital l'Archet 2

Nice, , France

Hôpital d'Enfants Armand-Trousseau

Paris, , France

Hôpital universitaire Robert-Debré (AP-HP)

Paris, , France

Institut Curie

Paris, , France

CHU de Poitiers

Poitiers, , France

CHU de Reims - Hôpital Américain

Reims, , France

Chu Hopital Sud Rennes

Rennes, , France

CHU de Rouen - Hôp. Charles NICOLLE

Rouen, , France

CHU Saint-Etienne - Hôpital Nord

Saint-Etienne, , France

Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

Strasbourg, , France

CHU Hôpital des Enfants

Toulouse, , France

CHU TOURS - Hôpital Clocheville

Tours, , France

CHU Nancy - Hôpital d'Enfants

Vandœuvre-lès-Nancy, , France

Gustave Roussy

Villejuif, , France

Countries

France

Other Identifiers

IC 2017-02

Identifier Type: -

Identifier Source: org_study_id