Integrative Molecular Analysis of Individual Radiosensitivity in Pediatric Oncology (FOCUSO)

Analysis of the individual radiosensitivity in pediatric oncology

Study Overview

• Status: Recruiting
• Conditions: Pediatric Cancer; Radiation Toxicity; Radiosensitivity
• Intervention / Treatment: Biological: Blood sample

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sandrine PEREIRA, PhD; Phone Number: 0643957510; Email: spereira@neolys-diagnostics.fr
• Study Contact Backup: Name: Jennifer RUOS; Email: jruos@fondation-force.fr

Study Locations

• France
  • Caen, France
    • Recruiting
    • Centre Francois Baclesse
    • Contact: Fernand Missohou, MD
  • Lille, France
    • Not yet recruiting
    • Centre Oscar Lambret
    • Contact: Xavier Mirabel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiosensitivity; Patients who agree to participate in this research study will have blood sample collected to perform the RadioDtect test	Biological: Blood sample; Blood sample collection : 2 X 5 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Neolys
• Collaborators: Centre Francois Baclesse; Centre Hospitalier Universitaire de Caen; Institut de cancérologie Strasbourg Europe; Centre Oscar Lambret, Lille, France

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2023
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): October 30, 2027

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: September 8, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: FOCUSO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No