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

Sponsor
Institut Curie (Other)
Overall Status
Recruiting
CT.gov ID
NCT03496402
Collaborator
(none)
600
Enrollment
30
Locations
2
Arms
104.4
Anticipated Duration (Months)
20
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Methodology:

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

Condition or Disease Intervention/Treatment Phase
  • Other: Sampling on blood, bone marrow and cerebrospinal fluid
 N/A

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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 -
Actual Study Start Date :
Apr 20, 2018
Anticipated Primary Completion Date :
Apr 18, 2026
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Other: Sampling on blood, bone marrow and cerebrospinal fluid
biological sampling during treatment and follow-up
Experimental: 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

Other: Sampling on blood, bone marrow and cerebrospinal fluid
biological sampling during treatment and follow-up

Outcome Measures

Primary Outcome Measures

  1. Number of patients with meaningful molecular genetic alterations [At the end of study (6 years)]

    Identification of molecular genetic alterations based on molecular characterisation of tumor at diagnosis, during patient treatment and follow-up (time dimension)

  2. Number of patients with meaningful immunological features [At the end of study (6 years)]

    Identification and characterisation of the tumor microenvironment and the host's immunological profile, at diagnosis and during patient treatment

  3. Number of patients with identification of new tumor-specific genetic characteristics during follow-up (clonal evolution) [up to 6 years]

    Comparison between genetic variations identified at diagnosis and those identified on circulating tumor DNA during treatment, FU and/or relapse

Secondary Outcome Measures

  1. Correlation between disease recurrence and molecular and/or immunological biomarkers [up to 6 years]

    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

  2. Correlation between genetic variations and immune parameters [up to 6 years]

    To compare molecular and immunological findings at diagnosis and during treatment (data integration)

  3. Correlation between disease staging and immunological features [up to 6 years]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

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

Exclusion Criteria:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu D'Amiens Picardie Amiens France 80054
2 CHU Angers Angers France 49933
3 CHRU de Besançon - Hôpital Jean-Minjoz Besançon France 25030
4 CHU de Bordeaux - Hôpital des enfants - Groupe Hospitalier Pellegrin Bordeaux France 33076
5 CHRU de Brest Brest France 29609
6 CHU CAEN Caen France 14033
7 Centre Régional de Cancérologie et Thrapie Cellulaire Pdiatrique (CRCTCP) Clermont-Ferrand France 63003
8 CHU Hôpital d'Enfants Dijon France 21079
9 CHU GRENOBLE Alpes - Hôpital Couple-Enfant Grenoble France 38043
10 Centre Oscar Lambret Lille France 59020
11 CHU de Limoges - Hôpital Mère-Enfant Limoges France 87042
12 Centre Léon Bérard Lyon France 69373
13 Hospices Civils de Lyon Lyon France 69373
14 Hôpital d'Enfants de la Timone (AP-HM) Marseille France 13385
15 CHU Arnaud de Villeneuve Montpellier France 34295
16 CHU Nantes - Hôpital Mère Enfant Nantes France 44093
17 Hôpital l'Archet 2 Nice France BP 3079
18 Hôpital d'Enfants Armand-Trousseau Paris France 75012
19 Hôpital universitaire Robert-Debré (AP-HP) Paris France 75019
20 Institut Curie Paris France 750248
21 CHU de Poitiers Poitiers France 86021
22 CHU de Reims - Hôpital Américain Reims France 51100
23 Chu Hopital Sud Rennes Rennes France 35056
24 CHU de Rouen - Hôp. Charles NICOLLE Rouen France 76031
25 CHU Saint-Etienne - Hôpital Nord Saint-Étienne France 42055
26 Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre Strasbourg France 67098
27 CHU Hôpital des Enfants Toulouse France 31059
28 CHU TOURS - Hôpital Clocheville Tours France 37044
29 CHU Nancy - Hôpital d'Enfants Vandoeuvre les Nancy France 54500
30 Gustave Roussy Villejuif France 94805

Sponsors and Collaborators

  • Institut Curie

Investigators

  • Principal Investigator: Gudrun SCHLEIERMACHER, MD, Institut Curie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut Curie
ClinicalTrials.gov Identifier:
NCT03496402
Other Study ID Numbers:
  • IC 2017-02
First Posted:
Apr 12, 2018
Last Update Posted:
Feb 24, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neuroblastoma
Osteosarcoma
Rhabdomyosarcoma
Sarcoma, Ewing
Nervous System Neoplasms
Central Nervous System Neoplasms

Study Results

No Results Posted as of Feb 24, 2022