Unusual Toxicity Induced by Radiotherapy (CRYOTOX)

Institut de Cancérologie de Lorraine

Status: Completed

Conditions: Cancer

Treatments: Other: skin biopsy; Other: blood sample; Other: tumor biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT03980977

2017 A00266-47

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

skin and/or tumor Biopsy and blood sample

Other group

Treatment:

Other: blood sample

Other: skin biopsy

Other: tumor biopsy