Sign in

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
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

Full criteria on ClinicalTrials.gov

Sites (30)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU d'Amiens-Picardie
Coordinator of this site? Confirm its status
AmiensFranceUnknown status
CHU Angers
Coordinator of this site? Confirm its status
AngersFranceUnknown status
CHRU de Besançon- Hopital Jean Minjoz
Coordinator of this site? Confirm its status
BesançonFranceUnknown status
CHU de Bordeaux - Hôpital des enfants - Groupe Hospitalier Pellegrin
Coordinator of this site? Confirm its status
BordeauxFranceUnknown status
CHRU de Brest
Coordinator of this site? Confirm its status
BrestFranceUnknown status
CHU Caen
Coordinator of this site? Confirm its status
CaenFranceUnknown status
Centre Régional de Cancérologie et Thrapie Cellulaire Pdiatrique (CRCTCP)
Coordinator of this site? Confirm its status
Clermont-FerrandFranceUnknown status
CHU Hôpital d'Enfants
Coordinator of this site? Confirm its status
DijonFranceUnknown status
CHU Grenoble Alpes - Hôpital Couple-Enfant
Coordinator of this site? Confirm its status
GrenobleFranceUnknown status
Centre Oscar Lambret
Coordinator of this site? Confirm its status
LilleFranceUnknown status
CHU de Limoges - Hôpital Mère-Enfant
Coordinator of this site? Confirm its status
LimogesFranceUnknown status
Centre Leon Berard
Coordinator of this site? Confirm its status
LyonFranceUnknown status
Hospices Civils de Lyon
Coordinator of this site? Confirm its status
LyonFranceUnknown status
Hôpital d'Enfants de la Timone (AP-HM)
Coordinator of this site? Confirm its status
MarseilleFranceUnknown status
CHU Arnaud de Villeneuve
Coordinator of this site? Confirm its status
MontpellierFranceUnknown status
CHU Nantes Hôpital Mère-Enfant
Coordinator of this site? Confirm its status
NantesFranceUnknown status
Hôpital l'Archet 2
Coordinator of this site? Confirm its status
NiceFranceUnknown status
Institut Curie
Coordinator of this site? Confirm its status
ParisFranceUnknown status
Hôpital universitaire Robert-Debré (AP-HP)
Coordinator of this site? Confirm its status
ParisFranceUnknown status
Hôpital d'Enfants Armand-Trousseau
Coordinator of this site? Confirm its status
ParisFranceUnknown status
CHU de Poitiers
Coordinator of this site? Confirm its status
PoitiersFranceUnknown status
CHU de Reims - Hôpital Américain
Coordinator of this site? Confirm its status
ReimsFranceUnknown status
Chu Hopital Sud Rennes
Coordinator of this site? Confirm its status
RennesFranceUnknown status
CHU de Rouen - Hôp. Charles NICOLLE
Coordinator of this site? Confirm its status
RouenFranceUnknown status
CHU Saint Etienne Hôpital Nord
Coordinator of this site? Confirm its status
Saint-EtienneFranceUnknown status
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
Coordinator of this site? Confirm its status
StrasbourgFranceUnknown status
CHU Hôpital des Enfants
Coordinator of this site? Confirm its status
ToulouseFranceUnknown status
CHU Tours Hôpital Clocheville
Coordinator of this site? Confirm its status
ToursFranceUnknown status
CHU NANCY- Hôpital d'Enfants
Coordinator of this site? Confirm its status
Vandœuvre-lès-NancyFranceUnknown status
Gustave Roussy
Coordinator of this site? Confirm its status
VillejuifFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.