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Unusual Toxicity Induced by Radiotherapy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03980977
Acronym
CRYOTOX
Enrollment
45
Registered
2019-06-10
Start date
2018-05-04
Completion date
2023-04-27
Last updated
2023-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

unusual toxicity, radiosensitivity, radiotherapy, fibroblast cell, indirect immunofluorescence test

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.

Interventions

OTHERskin 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).

OTHERtumor biopsy

an additional tumor sample will be taken during programmed diagnostic procedure.

OTHERblood sample

blood sample will be taken for biological collection

Sponsors

Institut de Cancérologie de Lorraine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
skin fibroblast radiosensitivity2 to 3 months after skin biopsyThe 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

MeasureTime frameDescription
tumor cells radiosensitivity2 to 3 months after tumor biopsyThe 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026