Integrative Molecular Analysis of Individual Radiosensitivity in Pediatric Oncology

Pediatric Cancer Clinical Trial

— FOCUSO  

Official title:

Integrative Molecular Analysis of Individual Radiosensitivity in Pediatric Oncology

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06033183
• Other study ID #: FOCUSO
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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: -

Related Conditions & MeSH terms

• Pediatric Cancer
• Radiation Toxicity
• Radiosensitivity

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