Clinical trial · Interventional
Description of Individual Radiosensitivity With Molecular Biomarkers in a Pediatric Oncology Population
Integrative Molecular Analysis of Individual Radiosensitivity Among a Population of Pediatric Patients Treated With Radiation in Eastern France.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The liquidation of our industrial partner NEOLYS Diagnostics, directly involved in the methodology of the study and a sub-optimal rate of inclusions which did not allow us to include all patient within the allotted time.
Summary
Brief summary (as posted)
This study aims to explore prospectively the distribution of individual radiosensitivity in the pediatric population and to determine the predictive power of individual radiosensitivity biomarkers from an immunofluorescence technique on primary dermal fibroblasts
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer-related Problem/Condition | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| skin biopsy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- ARPEGE BioM
- description
- N/A (not a randomized study)
- interventionNames
- Other: skin biopsy
Primary outcomes (1)
- measure
- skin fibroblast radiosenstivity
- timeFrame
- up to 5 months
- description
- residual double-strand breaks 24h after ex vivo radiation assessed with indirect immunofluorescence (gammaH2AX marker).
Secondary outcomes (4)
- measure
- early cutaneous, mucosal and hematological early radiation toxicity
- timeFrame
- 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Children \< 18 years old * Patient with an indication of radiotherapy * Patient must be affiliated to a social security system * Patient under parental autority * Ability to provide an informed written consent form Exclusion Criteria: * Contraindications for skin biopsy * Contraindications for radiotherapy * Referred to palliative radiotherapy * Prior radiotherapy in the same area * Indication of hypofractionated radiotherapy * Patient monitoring impossible * Patients deprived of liberty or under supervision
References
Publications (1)
- DERIVEDBernier-Chastagner V, Hettal L, Gillon V, Fernandes L, Huin-Schohn C, Vazel M, Tosti P, Salleron J, Francois A, Cerimele E, Perreira S, Peiffert D, Chastagner P, Vogin G. Validation of a high performance functional assay for individual radiosensitivity in pediatric oncology: a prospective cohort study (ARPEGE). BMC Cancer. 2018 Jul 6;18(1):719. doi: 10.1186/s12885-018-4652-7. PMID 29976172