NCT03496402Active, not recruiting
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 -
Source: ClinicalTrials.gov · Last updated 18 Mar 2025
Brief summary (registry, in English)
Methodology: Prospective, multicentric, open, non-randomised, non-therapeutic, interventional study
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 26 Feb 2018
- Start date
- 20 Apr 2018
- Primary completion date
- 19 Apr 2027
- Lead sponsor
- Institut Curie
- Diseases
- Neuroblastoma, Childhood cancers, Sarcoma
- NCT number
- NCT03496402
What you commit to
- Study type: Interventional
- Planned participants: 600
- From 20 Apr 2018 to the primary completion date, 19 Apr 2027
- 30 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- 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
Other
- Main non-inclusion Criteria common to all study cohorts:
Who the study is looking for
- 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
- 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
Age in the registry: 1 year to 25 years · Sex: All · Does not accept healthy volunteers
Sites (30)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU d'Amiens-Picardie Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| CHU Angers Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| CHRU de Besançon- Hopital Jean Minjoz Coordinator of this site? Confirm its status | Besançon | France | Unknown status |
| CHU de Bordeaux - Hôpital des enfants - Groupe Hospitalier Pellegrin Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| CHRU de Brest Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| CHU Caen Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| Centre Régional de Cancérologie et Thrapie Cellulaire Pdiatrique (CRCTCP) Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| CHU Hôpital d'Enfants Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| CHU Grenoble Alpes - Hôpital Couple-Enfant Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| Centre Oscar Lambret Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| CHU de Limoges - Hôpital Mère-Enfant Coordinator of this site? Confirm its status | Limoges | France | Unknown status |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Hôpital d'Enfants de la Timone (AP-HM) Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| CHU Arnaud de Villeneuve Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| CHU Nantes Hôpital Mère-Enfant Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Hôpital l'Archet 2 Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| Institut Curie Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital universitaire Robert-Debré (AP-HP) Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital d'Enfants Armand-Trousseau Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| CHU de Reims - Hôpital Américain Coordinator of this site? Confirm its status | Reims | France | Unknown status |
| Chu Hopital Sud Rennes Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| CHU de Rouen - Hôp. Charles NICOLLE Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| CHU Saint Etienne Hôpital Nord Coordinator of this site? Confirm its status | Saint-Etienne | France | Unknown status |
| Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| CHU Hôpital des Enfants Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| CHU Tours Hôpital Clocheville Coordinator of this site? Confirm its status | Tours | France | Unknown status |
| CHU NANCY- Hôpital d'Enfants Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Unknown status |
| Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.