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Completed

NCT Number: NCT03980977

Unusual Toxicity Induced by Radiotherapy

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.

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Key information

Conditions

Cancer Neoplasms

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skin biopsy

Other

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

Other

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

blood sample

Other

blood sample will be taken for biological collection

Primary outcomes

  1. skin fibroblast radiosensitivity

    Time frame: 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 outcomes

  1. tumor cells radiosensitivity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Official study title

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

Acronym: CRYOTOX

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jun 10, 2019
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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