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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	1 Year - 25 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03496402
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Institut Curie
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Gudrun SCHLEIERMACHER, MD
Principal Investigator Affiliation	Institut Curie
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neuroblastoma, Rhabdomyosarcoma, Ewing Sarcoma Family of Tumors, Osteosarcoma, Leukemia, Central Nervous System Tumor

Additional Details

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).

Arms & Interventions

Arms

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

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

Interventions

Other: - Sampling on blood, bone marrow and cerebrospinal fluid

biological sampling during treatment and follow-up

Contact a Trial Team

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International Sites

Chu D'Amiens Picardie, Amiens, France

Status

Recruiting

Address

Chu D'Amiens Picardie

Amiens, , 80054

Site Contact

Catherine DEVOLDERE, MD

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