Unusual Toxicity Induced by Radiotherapy

Study Overview
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Brief Summary
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In order to evaluate the physiopathological knowledge of the different pathological manifestations associated with individual radiosensitivity, it seems essential to carry out this pilot study. It has agglomerated homogeneous tissue samples to identify new biomarkers for patient diagnosis and follow-up, and may predict the therapeutic response. These knowledge will help to treatment customization.

Official Title
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Collection of Biological Samples for Stydy of Unusual Toxicity Induced by Radiotherapy

Conditions
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Cancer

Intervention / Treatment
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* Other: skin biopsy
* Other: tumor biopsy
* Other: blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child or teenager aged 2 to <18 Man, Woman> 18 years old Patient with one of these situations: Unusual toxicity in progress or after radiotherapy Indication of radiotherapy and suspicion of abnormal pathways of response to ionizing radiation - constitutional (genetic disease) or acquired (systemic disease) - which may generate unusual radioinduced toxicity Patient information and informed consent signed by the patient. For children and teenager : information to parents and obtaining informed consent Affiliation to a social security scheme. Exclusion Criteria: Contraindication for skin and / or tumoral biopsy Contraindication for blood sample of 2.5 ml Persons deprived of liberty or under supervision

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: skin and/or tumor Biopsy and blood sample<br> | Other: skin biopsy<br>* skin biopsy will be taken under local anesthesia using a patch of lidocaine and prilocaine. In practice, during the skin biopsy, the skin must be cleaned with chlorhexidine or alcohol, to the exclusion of any other antiseptic. The biopsy will preferably be done with a dermatome (or punch, 12 G).<br>Other: tumor biopsy<br>* an additional tumor sample will be taken during programmed diagnostic procedure.<br>Other: blood sample<br>* blood sample will be taken for biological collection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin fibroblast radiosensitivity | The number of residual double strand break at 24 hours (number of 53BP1 foci) after a dose of 2 Gy will be quantified with indirect immunofluorescence | 2 to 3 months after skin biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor cells radiosensitivity | The number of residual double strand break at 24 hours (number of 53BP1 foci) after a dose of 2 Gy will be quantified with indirect immunofluorescence | 2 to 3 months after tumor biopsy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unusual toxicity, radiosensitivity, radiotherapy, fibroblast cell, indirect immunofluorescence test