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NCT Number: NCT06033183

Integrative Molecular Analysis of Individual Radiosensitivity in Pediatric Oncology

Analysis of the individual radiosensitivity in pediatric oncology

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Key information

Conditions

Radiosensitivity Neoplasms Pediatric Cancer Radiation Injuries Radiation Toxicity Wounds and Injuries

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre François Baclesse, Caen, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Blood sample

Biological

Blood sample collection : 2 X 5 ml

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  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

    Time frame: 12 months

    evaluation of late toxicities of grade ≥ 2, according to NCI-CTCAE v4.03 criteria

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer RUOS

CONTACT

[email protected]

Sandrine PEREIRA, PhD

CONTACT

[email protected]

0643957510

Sponsors and collaborators

Lead sponsor

Neolys

Industry

Collaborators

  • Centre Francois Baclesse
  • Centre Hospitalier Universitaire de Caen
  • Centre Oscar Lambret, Lille, France
  • Institut de cancérologie Strasbourg Europe

Registry information

Acronym: FOCUSO

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 13, 2023
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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