FOCUSO: Integrative Molecular Analysis of Individual Radiosensitivity in Pediatric Oncology

Sponsor

Neolys (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06033183

Collaborator

Centre Francois Baclesse (Other), Centre Hospitalier Universitaire de Caen (Other)

100

Enrollment

Arm

47.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Analysis of the individual radiosensitivity in pediatric oncology

Condition or Disease	Intervention/Treatment	Phase
Radiosensitivity Pediatric Cancer Radiation Toxicity	Biological: Blood sample	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Integrative Molecular Analysis of Individual Radiosensitivity in Pediatric Oncology

Anticipated Study Start Date :

Nov 2, 2023

Anticipated Primary Completion Date :

Aug 30, 2027

Anticipated Study Completion Date :

Oct 30, 2027

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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
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

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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)

Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Neolys
Centre Francois Baclesse
Centre Hospitalier Universitaire de Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Neolys

ClinicalTrials.gov Identifier:

NCT06033183

Other Study ID Numbers:

FOCUSO

First Posted:

Sep 13, 2023

Last Update Posted:

Sep 13, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 13, 2023