Methodology:
Prospective, multicentric, open, non-randomised, non-therapeutic, interventional study
Condition or disease | Intervention/treatment | Phase |
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Neuroblastoma Rhabdomyosarcoma Ewing Sarcoma Family of Tumors Osteosarcoma Leukemia Central Nervous System Tumor | Other: Sampling on blood, bone marrow and cerebrospinal fluid | Not Applicable |
To identify and characterise:
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
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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
Ages Eligible for Study: | 1 Year to 25 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
High risk Ewing sarcoma:
High risk osteosarcoma:
- Metastatic osteosarcoma
- Localised inoperable osteosarcoma
High risk leukaemia:
Cohort 2:
• Extra cerebral or cerebral high risk tumours including:
Cohort 3:
Children, adolescents and young adults, with low/intermediate risk cancers belonging to the following types:
• Neuroblastoma:
- Localised, without MYCN amplification
Stage 4s, in infants (younger than one year at diagnosis), without MYCN amplification
• Rhabdomyosarcoma:
Localised, without Foxo1 rearrangement
• ESFT:
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
Contact: Gudrun SCHLEIERMACHER, MD | +33(0)144324554 | gudrun.schleiermacher@curie.fr | |
Contact: Eve LAPOUBLE, PhD | +33(0)156245811 | eve.lapouble@curie.fr |
Principal Investigator: | Gudrun SCHLEIERMACHER, MD | Institut Curie |
Tracking Information | |||||||||
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First Submitted Date ICMJE | February 26, 2018 | ||||||||
First Posted Date ICMJE | April 12, 2018 | ||||||||
Last Update Posted Date | April 9, 2019 | ||||||||
Actual Study Start Date ICMJE | April 20, 2018 | ||||||||
Estimated Primary Completion Date | April 1, 2025 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Biological Characterisation of High Risk CHildhood Cancer in Children, Adolescents and Young Adults (MICCHADO) | ||||||||
Official Title ICMJE | Molecular and Immunological Characterisation of High Risk CHildhood Cancer At DiagnOsis, Treatment and Follow-up - Biological Evaluation in Children, Adolescents and Young Adults - | ||||||||
Brief Summary |
Methodology: Prospective, multicentric, open, non-randomised, non-therapeutic, interventional study |
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Detailed Description |
To identify and characterise:
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Other |
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Condition ICMJE |
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Intervention ICMJE | Other: Sampling on blood, bone marrow and cerebrospinal fluid
biological sampling during treatment and follow-up
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
600 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | April 1, 2026 | ||||||||
Estimated Primary Completion Date | April 1, 2025 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
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 |
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Sex/Gender ICMJE |
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Ages ICMJE | 1 Year to 25 Years (Child, Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | France | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03496402 | ||||||||
Other Study ID Numbers ICMJE | IC 2017-02 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Institut Curie | ||||||||
Study Sponsor ICMJE | Institut Curie | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Institut Curie | ||||||||
Verification Date | April 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |