NCT06033183

Brief Summary

Analysis of the individual radiosensitivity in pediatric oncology

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Dec 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Dec 2023Oct 2027

First Submitted

Initial submission to the registry

August 25, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

December 2, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2027

Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

3.7 years

First QC Date

August 25, 2023

Last Update Submit

November 19, 2024

Conditions

RadiosensitivityPediatric CancerRadiation Toxicity

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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

  • 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

Study Arms (1)

Radiosensitivity

EXPERIMENTAL

Patients who agree to participate in this research study will have blood sample collected to perform the RadioDtect test

Biological: Blood sample

Interventions

Blood sampleBIOLOGICAL

Blood sample collection : 2 X 5 ml

Radiosensitivity

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre François Baclesse

Caen, France

RECRUITING

Centre Oscar Lambret

Lille, France

NOT YET RECRUITING

MeSH Terms

Conditions

NeoplasmsRadiation Injuries

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Sandrine PEREIRA, PhD

CONTACT

0643957510spereira@neolys-diagnostics.fr

Jennifer RUOS

CONTACT

jruos@fondation-force.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2023

First Posted

September 13, 2023

Study Start

December 2, 2023

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

October 30, 2027

Last Updated

November 22, 2024

Record last verified: 2024-11

Locations

FR(2)