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

September 8, 2023 updated by: Neolys
Analysis of the individual radiosensitivity in pediatric oncology

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: 24 months
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.
Time Frame: 24 months
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
Time Frame: 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
Time Frame: 12 months
evaluation of late toxicities of grade ≥ 2, according to NCI-CTCAE v4.03 criteria
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neolys

Collaborators

Centre Francois Baclesse
Centre Hospitalier Universitaire de Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 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 (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

August 1, 2023

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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