Unusual Toxicity Induced by Radiotherapy

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Other: skin biopsy; Other: tumor biopsy; Other: blood sample

• Registration Number: NCT03980977
• Lead Sponsor: Institut de Cancérologie de Lorraine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-04
• Study First Submitted: 2019-06-03
• Study First Submitted QC: 2019-06-07
• Study First Posted: 2019-06-10
• Primary Completion: 2023-04-26
• Study Completion: 2023-04-27
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
skin and/or tumor Biopsy and blood sample	skin biopsy	-
skin and/or tumor Biopsy and blood sample	blood sample	-
skin and/or tumor Biopsy and blood sample	tumor biopsy	-

Primary Outcome Measures

Name	Time	Method
skin fibroblast radiosensitivity	2 to 3 months after skin biopsy	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

Secondary Outcome Measures

Name	Time	Method
tumor cells radiosensitivity	2 to 3 months after tumor biopsy	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

Trial Locations

Locations (1)

Institut de Cancérologie de Lorraine; 🇫🇷 Vandœuvre-lès-Nancy, France