Unusual Toxicity Induced by Radiotherapy (CRYOTOX)

November 29, 2023 updated by: Institut de Cancérologie de Lorraine

Collection of Biological Samples for Stydy of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandœuvre-lès-Nancy, France, 54519
        • Institut De Cancerologie De Lorraine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: skin and/or tumor Biopsy and blood sample
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).
Other: tumor biopsy
an additional tumor sample will be taken during programmed diagnostic procedure.
Other: blood sample
blood sample will be taken for biological collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 to 3 months after skin biopsy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 to 3 months after tumor biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Cancérologie de Lorraine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2018

Primary Completion (Actual)

April 26, 2023

Study Completion (Actual)

April 27, 2023

Study Registration Dates

First Submitted

June 3, 2019

First Submitted That Met QC Criteria

June 7, 2019

First Posted (Actual)

June 10, 2019

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2017 A00266-47

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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