Integrative Molecular Analysis of Individual Radiosensitivity in Pediatric Oncology

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06033183

Acronym

FOCUSO

Enrollment

100

Registered

2023-09-13

Start date

2023-12-02

Completion date

2027-10-30

Last updated

2024-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Cancer, Radiation Toxicity, Radiosensitivity

Brief summary

Analysis of the individual radiosensitivity in pediatric oncology

Interventions

BIOLOGICALBlood sample

Blood sample collection : 2 X 5 ml

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 18 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Prospectively validate the discriminating capacities of the RadioDtect© individual radiosensitivity blood test on the occurrence of early radio-induced toxicities.	24 months	The validation will be based on ATM protein quantification assay to predict acute toxicities

Secondary

Measure	Time frame	Description
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	12 months	The validation will be based on ATM protein quantification assay to predict late toxicities

Countries

France

Contacts

Primary ContactSandrine PEREIRA, PhD

spereira@neolys-diagnostics.fr0643957510

Backup ContactJennifer RUOS

jruos@fondation-force.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026