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

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ClinicalTrials.gov Identifier: NCT03496402
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Curie

Brief Summary:

Methodology:

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


Condition or disease Intervention/treatment Phase
Neuroblastoma Rhabdomyosarcoma Ewing Sarcoma Family of Tumors Osteosarcoma Leukemia Central Nervous System Tumor Other: Sampling on blood, bone marrow and cerebrospinal fluid Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 20, 2018
Estimated Primary Completion Date : April 1, 2025
Estimated Study Completion Date : April 1, 2026


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




Primary Outcome Measures :
  1. Number of patients with meaningful molecular genetic alterations [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

    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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496402


Contacts
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Contact: Gudrun SCHLEIERMACHER, MD +33(0)144324554 gudrun.schleiermacher@curie.fr
Contact: Eve LAPOUBLE, PhD +33(0)156245811 eve.lapouble@curie.fr

Locations
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France
Chu D'Amiens Picardie Not yet recruiting
Amiens, France, 80054
Contact: Catherine DEVOLDERE, MD       devoldere.catherine@chu-amiens.fr   
CHU Angers Not yet recruiting
Angers, France, 49933
Contact: Isabelle PELLIER, MD    (+33) 02.41.35.38.63    ispellier@chu-angers.fr   
CHRU de Besançon - Hôpital Jean-Minjoz Not yet recruiting
Besançon, France, 25030
Contact: Sebastien KLEIN, MD    (+33) 03 81 21 81 38    s1klein@chu-besancon.fr   
CHU de Bordeaux - Hôpital des enfants - Groupe Hospitalier Pellegrin Not yet recruiting
Bordeaux, France, 33076
Contact: Yves PEREL, MD    (+33) 05 57 82 04 38    yves.perel@chu-bordeaux.fr   
CHRU de Brest Not yet recruiting
Brest, France, 29609
Contact: Liana-Stéphania CARAUSU, MD    (+33) 02 98 22 37 70    liana.carausu@chu-brest.fr   
CHU CAEN Not yet recruiting
Caen, France, 14033
Contact: Marianna DEPARIS, MD    (+33) 02 31 06 50 82    deparis-m@chu-caen.fr   
Centre Régional de Cancérologie et Thrapie Cellulaire Pdiatrique (CRCTCP) Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: Justyna KANOLD, MD    (+33) 04 73 75 00 09    jkanold@chu-clermontferrand.fr   
CHU Hôpital d'Enfants Not yet recruiting
Dijon, France, 21079
Contact: Claire BRIANDET, MD    (+33) 03 80 29 36 01    claire.briandet@chu-dijon.fr   
CHU GRENOBLE Alpes - Hôpital Couple-Enfant Not yet recruiting
Grenoble, France, 38043
Contact: Dominique PLANTAZ, MD    (+33) 04 76 76 59 11    DPlantaz@chu-grenoble.fr   
Centre Oscar Lambret Not yet recruiting
Lille, France, 59020
Contact: Anne-Sophie DEFACHELLESTHOMASSIN, MD    (+33) 03 20 59 06    AS-Defachelles@o-lambret.fr   
CHU de Limoges - Hôpital Mère-Enfant Not yet recruiting
Limoges, France, 87042
Contact: Christophe PIGUET, MD    (+33) 05 55 05 68 01    christophe.piguet@chu-limoges.fr   
Centre Léon Bérard Not yet recruiting
Lyon, France, 69373
Contact: Nadège CORRADINI, MD    (+33) 04 78 78 26 42    Nadege.corradini@ihope.fr   
Hospices Civils de Lyon Not yet recruiting
Lyon, France, 69373
Contact: Yves BERTRAND, MD    (+33) 04 69 16 65 70    Yves.bertrand@ihope.fr   
Hôpital d'Enfants de la Timone (AP-HM) Not yet recruiting
Marseille, France, 13385
Contact: Carole COZE, MD       carole.coze@ap-hm.fr   
CHU Arnaud de Villeneuve Not yet recruiting
Montpellier, France, 34295
Contact: Laure SAUMET, MD    (+33) 04 67 33 65 19    l-saumet@chu-montpellier.fr   
CHU Nantes - Hôpital Mère Enfant Not yet recruiting
Nantes, France, 44093
Contact: Charlotte RIGAUD, MD    (+33) 02 40 08 36 10    charlotte.rigaud@chu-nantes.fr   
Hôpital l'Archet 2 Not yet recruiting
Nice, France, BP 3079
Contact: Pierre-Simon ROHRLICH, MD    (+33) 04 92 03 92 68    rohrlich.ps@chu-nice.fr   
Hôpital d'Enfants Armand-Trousseau Not yet recruiting
Paris, France, 75012
Contact: Arnaud PETIT, MD    (+33) 01.71.73.82.57    arnaud.petit@trs.aphp.fr   
Hôpital universitaire Robert-Debré (AP-HP) Not yet recruiting
Paris, France, 75019
Contact: André BARUCHEL, MD    (+33) 01 40 03 53 88    andre.baruchel@aphp.fr   
Institut Curie Recruiting
Paris, France, 750248
Contact: Gudrun SCHLEIERMACHER, MD    + 00 33 (0)1.44.32.45.51    gudrun.schleiermacher@curie.fr   
CHU de Poitiers Not yet recruiting
Poitiers, France, 86021
Contact: Frédéric MILLOT, MD    (+33) 05.49.44.30.78    f.millot@chu-poitiers.fr   
CHU de Reims - Hôpital Américain Not yet recruiting
Reims, France, 51100
Contact: Claire PLUCHART, MD    (+33) 03 26 78 41 54    cpluchart@chu-reims.fr   
Chu Hopital Sud Rennes Not yet recruiting
Rennes, France, 35056
Contact: Sophie TAQUE, MD    (+33) 02 99 26 58 35    sophie.taque@chu-rennes.fr   
CHU de Rouen - Hôp. Charles NICOLLE Not yet recruiting
Rouen, France, 76031
Contact: Pascale SCHNEIDER, MD    (+33) 02 32 88 81 91    pascale.schneider@chu-rouen.fr   
CHU Saint-Etienne - Hôpital Nord Not yet recruiting
Saint-Étienne, France, 42055
Contact: Audrey DAVID, MD    (+33) 04 77 82 88 08    audrey.david@chu-st-etienne.fr   
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre Not yet recruiting
Strasbourg, France, 67098
Contact: Catherine PAILLARD, MD    (+33) 03.88.12.80.91    catherine.paillard@chru-strasbourg.fr   
CHU Hôpital des Enfants Not yet recruiting
Toulouse, France, 31059
Contact: Marion GAMBART, MD    (+33) 05 34 55 84 26    gambart.m@chu-toulouse.fr   
CHU TOURS - Hôpital Clocheville Not yet recruiting
Tours, France, 37044
Contact: Pascale BLOUIN, MD    (+33) 02 47 47 47 51    p.blouin@chu-tours.fr   
CHU Nancy - Hôpital d'Enfants Not yet recruiting
Vandoeuvre les Nancy, France, 54500
Contact: Pascal CHASTAGNER, MD    (+33) 03 83 15 47 36    p.chastagner@chru-nancy.fr   
Gustave Roussy Not yet recruiting
Villejuif, France, 94805
Contact: Claudia PASQUALINI, MD    (+33) 01 42 11 37 58    Claudia.PASQUALINI@gustaveroussy.fr   
Sponsors and Collaborators
Institut Curie
Investigators
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Principal Investigator: Gudrun SCHLEIERMACHER, MD Institut Curie

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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT03496402     History of Changes
Other Study ID Numbers: IC 2017-02
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sarcoma, Ewing
Sarcoma
Neuroblastoma
Osteosarcoma
Rhabdomyosarcoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms by Site
Nervous System Diseases