Integrative Molecular Analysis of Individual Radiosensitivity in Pediatric Oncology

Study Overview
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Brief Summary
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Analysis of the individual radiosensitivity in pediatric oncology

Official Title
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Integrative Molecular Analysis of Individual Radiosensitivity in Pediatric Oncology

Conditions
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Radiosensitivity, Pediatric Cancer, Radiation Toxicity

Intervention / Treatment
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* Biological: Blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minor patient treated for a brain tumor, Ewing tumor, malignant mesenchymal tumor, neuroblastoma, nephroblastoma, Hodgkin's lymphoma treated with radiotherapy (+/- chemotherapy) for curative purposes. Children or adolescents > 3 years old and < 18 years old Patient with an indication for radiotherapy as part of the primary tumor local control strategy Theoretical indication for radiotherapy in standard fractionation (1.8 Gy to 2.2 Gy / fraction: 5 fr/week) whatever the technique and the particle used Patient affiliated with a social security scheme Patient and/or parents or holders of parental authority having dated and signed an informed consent Exclusion criteria: Patients with contraindications to blood sampling Patients with contraindications to radiotherapy Palliative radiotherapy Patient with previous RT treatment in the same area (re-irradiation) Patient with an indication of hypofractionated RT Patient follow-up not possible Persons deprived of liberty or under guardianship (including curatorship) Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiosensitivity<br>Patients who agree to participate in this research study will have blood sample collected to perform the RadioDtect test | Biological: Blood sample<br>* Blood sample collection : 2 X 5 ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prospectively validate the discriminating capacities of the RadioDtect© individual radiosensitivity blood test on the occurrence of early radio-induced toxicities. | The validation will be based on ATM protein quantification assay to predict acute toxicities | 24 months | 
| Prospectively validate the discriminating capacities of the RadioDtect© individual radiosensitivity blood test on the occurrence of early radio-induced toxicities. | evaluation of acute toxicities of grade ≥ 2 to 3 months according to NCI-CTCAE v4.03 criteria | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prospectively validate the discriminating capacities of the RadioDtect individual radiosensitivity blood test protein assay according on the occurrence of late radiation-induced toxicity at 12 months | The validation will be based on ATM protein quantification assay to predict late toxicities | 12 months | 
| Prospectively validate the discriminating capacities of the RadioDtect individual radiosensitivity blood test protein assay according on the occurrence of late radiation-induced toxicity at 12 months | evaluation of late toxicities of grade ≥ 2, according to NCI-CTCAE v4.03 criteria | 12 months |