Recruiting NCT06033183
Integrative Molecular Analysis of Individual Radiosensitivity in Pediatric Oncology
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sample.
- Who it may be relevant to
- Registry conditions: Radiosensitivity, Pediatric Cancer, Radiation Toxicity. Basic parameters: 3 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Analysis of the individual radiosensitivity in pediatric oncology
Interventions
- Biological Blood sample
Blood sample collection : 2 X 5 ml
Primary outcome measures
- Prospectively validate the discriminating capacities of the RadioDtect© individual radiosensitivity blood test on the occurrence of early radio-induced toxicities. [Time frame: 24 months]
- Prospectively validate the discriminating capacities of the RadioDtect© individual radiosensitivity blood test on the occurrence of early radio-induced toxicities. [Time frame: 24 months]
Secondary outcome measures (2)
- 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 [Time frame: 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 [Time frame: 12 months]
Eligibility criteria
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
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
France · 2 centers
- Centre François Baclesse — Caen
- Centre Oscar Lambret — Lille
Identifiers
NCT: NCT06033183 · FOCUSO