Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT03496402
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
25 Years
Study:
NCT03496402
Study Brief:
Protocol Section:
NCT03496402