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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06033183
Other study ID # FOCUSO
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 2, 2023
Est. completion date October 30, 2027

Study information

Verified date August 2023
Source Neolys
Contact Sandrine PEREIRA, PhD
Phone 0643957510
Email spereira@neolys-diagnostics.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Analysis of the individual radiosensitivity in pediatric oncology


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date October 30, 2027
Est. primary completion date August 30, 2027
Accepts healthy volunteers No
Gender All
Age group 3 Years to 18 Years
Eligibility 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: -

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Blood sample
Blood sample collection : 2 X 5 ml

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Neolys Centre Francois Baclesse, Centre Hospitalier Universitaire de Caen

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
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