Unusual Toxicity Induced by Radiotherapy

Cancer Clinical Trial

— CRYOTOX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03980977
• Other study ID #: 2017 A00266-47
• Status: Completed
• Phase: N/A
• Start date: May 4, 2018
• Est. completion date: April 27, 2023

Study information

• Verified date: November 2023
• Source: Institut de Cancérologie de Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 27, 2023
• Est. primary completion date: April 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• skin biopsy
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).
• tumor biopsy
an additional tumor sample will be taken during programmed diagnostic procedure.
• blood sample
blood sample will be taken for biological collection

Locations

Country	Name	City	State
France	Institut de Cancérologie de Lorraine	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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