Integrative Molecular Analysis of Individual Radiosensitivity in Pediatric Oncology
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-18
SponsorNeolys
About this trial
Analysis of the individual radiosensitivity in pediatric oncology
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients with contraindications to blood sampling
Patients with contraindications to radiotherapy
Palliative radiotherapy
Patient with previous RT treatment in the same area (re-irradiation)
Trial design
Design model
Single group
Treatments tested in this trial
Blood sample
Biological/VaccineBlood sample collection : 2 X 5 ml
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: RadiosensitivityExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
24 months2
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
Time frame
24 monthsSecondary outcomes
1
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
Time frame
12 months2
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
Time frame
12 monthsSponsors and contacts
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Neolys
Lead sponsor
Centre Francois Baclesse
Collaborator
Centre Hospitalier Universitaire de Caen
Collaborator
Institut de cancérologie Strasbourg Europe
Collaborator
Centre Oscar Lambret, Lille, France
Collaborator
Source ClinicalTrials.gov