Unusual Toxicity Induced by Radiotherapy

NCT ID: NCT03980977

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-04

Study Completion Date

2023-04-27

Brief Summary

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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

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Conditions

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Cancer

Keywords

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unusual toxicity radiosensitivity radiotherapy fibroblast cell indirect immunofluorescence test

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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skin and/or tumor Biopsy and blood sample

Group Type OTHER

skin biopsy

Intervention Type 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

Intervention Type OTHER

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

blood sample

Intervention Type OTHER

blood sample will be taken for biological collection

Interventions

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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).

Intervention Type OTHER

tumor biopsy

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

Intervention Type OTHER

blood sample

blood sample will be taken for biological collection

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut de Cancérologie de Lorraine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Other Identifiers

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2017 A00266-47

Identifier Type: -

Identifier Source: org_study_id