Integrative Molecular Analysis of Individual Radiosensitivity in Pediatric Oncology

Not Applicable

Recruiting

• Conditions: Radiosensitivity; Radiation Toxicity; Pediatric Cancer
• Interventions: Biological: Blood sample

• Registration Number: NCT06033183
• Lead Sponsor: Neolys

Brief Summary

Analysis of the individual radiosensitivity in pediatric oncology

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-25
• Study First Submitted QC: 2023-09-08
• Study First Posted: 2023-09-13
• Study Start: 2023-12-02
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-22
• Primary Completion: 2027-08-30
• Study Completion: 2027-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiosensitivity	Blood sample	Patients who agree to participate in this research study will have blood sample collected to perform the RadioDtect test

Primary Outcome Measures

Name	Time	Method
Prospectively validate the discriminating capacities of the RadioDtect© individual radiosensitivity blood test on the occurrence of early radio-induced toxicities.	24 months	evaluation of acute toxicities of grade ≥ 2 to 3 months according to NCI-CTCAE v4.03 criteria

Secondary Outcome Measures

Name	Time	Method
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	evaluation of late toxicities of grade ≥ 2, according to NCI-CTCAE v4.03 criteria

Trial Locations

Locations (2)

Centre François Baclesse; 🇫🇷 Caen, France

Centre Oscar Lambret; 🇫🇷 Lille, France