Integrative Molecular Analysis of Individual Radiosensitivity in Pediatric Oncology

Neolys2 sites in 1 country100 target enrollmentDecember 2, 2023

ConditionsRadiosensitivity Pediatric Cancer Radiation Toxicity

InterventionsBlood sample

DrugsBlood sample

Overview

Phase: Not Applicable
Intervention: Blood sample
Conditions: Radiosensitivity
Sponsor: Neolys
Enrollment: 100
Locations: 2
Primary Endpoint: Prospectively validate the discriminating capacities of the RadioDtect© individual radiosensitivity blood test on the occurrence of early radio-induced toxicities.
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Analysis of the individual radiosensitivity in pediatric oncology

Registry

clinicaltrials.gov

Start Date

December 2, 2023

End Date

October 30, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Neolys

Responsible Party

Sponsor

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

Exclusion Criteria

Not provided

Arms & Interventions

Radiosensitivity

Patients who agree to participate in this research study will have blood sample collected to perform the RadioDtect test

Intervention: Blood sample

Outcomes

Primary Outcomes

Prospectively validate the discriminating capacities of the RadioDtect© individual radiosensitivity blood test on the occurrence of early radio-induced toxicities.

Time Frame: 24 months

evaluation of acute toxicities of grade ≥ 2 to 3 months according to NCI-CTCAE v4.03 criteria

Secondary Outcomes

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)