Unusual Toxicity Induced by Radiotherapy

NCT03980977 | Completed

• 1 other identifier: 2017 A00266-47
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• tumor cells radiosensitivity

  2 to 3 months after tumor biopsy

Study Arms (1)

skin and/or tumor Biopsy and blood sample

OTHER

Other: skin biopsy; Other: tumor biopsy; Other: blood sample

Interventions

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).

skin and/or tumor Biopsy and blood sample

tumor biopsy OTHER

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

skin and/or tumor Biopsy and blood sample

blood sample OTHER

blood sample will be taken for biological collection

skin and/or tumor Biopsy and blood sample

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Contraindication for skin and / or tumoral biopsy
• Contraindication for blood sample of 2.5 ml
• Persons deprived of liberty or under supervision

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead

Study Sites (1)

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 10, 2019
• Study Start: May 4, 2018
• Primary Completion: April 26, 2023
• Study Completion: April 27, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)