Biological Characterisation of High Risk CHildhood Cancer in Children, Adolescents and Young Adults (MICCHADO) (MICCHADO)
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| ClinicalTrials.gov Identifier: NCT03496402 |
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Recruitment Status :
Recruiting
First Posted : April 12, 2018
Last Update Posted : April 9, 2019
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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 |
| 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 |
|---|---|
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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
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Other: Sampling on blood, bone marrow and cerebrospinal fluid
biological sampling during treatment and follow-up |
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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
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Other: Sampling on blood, bone marrow and cerebrospinal fluid
biological sampling during treatment and follow-up |
- 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)
- 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
- 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
- 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
- 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)
- 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
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.
| Ages Eligible for Study: | 1 Year to 25 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
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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:
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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
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High risk rhabdomyosarcoma:
- Foxo1 rearrangement any stage;
- and / or N1 ;
- and / or metastatic rhabdomyosarcoma
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High risk Ewing sarcoma:
- Metastatic Ewing sarcoma family of tumours (ESFT)
- Localised inoperable Ewing sarcoma with primary tumours ≥ 200 ml
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High risk osteosarcoma:
- Metastatic osteosarcoma
- Localised inoperable osteosarcoma
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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
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Stage 4s, in infants (younger than one year at diagnosis), without MYCN amplification
• Rhabdomyosarcoma:
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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:
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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
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
| Contact: Gudrun SCHLEIERMACHER, MD | +33(0)144324554 | gudrun.schleiermacher@curie.fr | |
| Contact: Eve LAPOUBLE, PhD | +33(0)156245811 | eve.lapouble@curie.fr |
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| Principal Investigator: | Gudrun SCHLEIERMACHER, MD | Institut Curie |
| Responsible Party: | Institut Curie |
| ClinicalTrials.gov Identifier: | NCT03496402 |
| Other Study ID Numbers: |
IC 2017-02 |
| First Posted: | April 12, 2018 Key Record Dates |
| Last Update Posted: | April 9, 2019 |
| Last Verified: | April 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Neuroblastoma Osteosarcoma Rhabdomyosarcoma Nervous System Neoplasms Central Nervous System Neoplasms Sarcoma, Ewing Neoplasms Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive |
Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Bone Tissue Neoplasms, Connective Tissue Myosarcoma Neoplasms, Muscle Tissue Neoplasms by Site Nervous System Diseases |