Integrative Molecular Analysis of Individual Radiosensitivity in Pediatric Oncology

NCT ID: NCT06033183

Last Updated: 2024-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-02

Study Completion Date

2027-10-30

Brief Summary

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Analysis of the individual radiosensitivity in pediatric oncology

Detailed Description

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Conditions

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Radiosensitivity Pediatric Cancer Radiation Toxicity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Radiosensitivity

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

Group Type EXPERIMENTAL

Blood sample

Intervention Type BIOLOGICAL

Blood sample collection : 2 X 5 ml

Interventions

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Blood sample

Blood sample collection : 2 X 5 ml

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)


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Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Francois Baclesse

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire de Caen

OTHER

Sponsor Role collaborator

Institut de cancérologie Strasbourg Europe

UNKNOWN

Sponsor Role collaborator

Centre Oscar Lambret, Lille, France

UNKNOWN

Sponsor Role collaborator

Neolys

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre François Baclesse

Caen, , France

Site Status RECRUITING

Centre Oscar Lambret

Lille, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Sandrine PEREIRA, PhD

Role: CONTACT

0643957510

Jennifer RUOS

Role: CONTACT

Facility Contacts

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Fernand Missohou, MD

Role: primary

Xavier Mirabel, MD

Role: primary

Other Identifiers

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FOCUSO

Identifier Type: -

Identifier Source: org_study_id

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