Cancer-related Problem/Condition Clinical Trial
— ARPEGE BioMOfficial title:
Integrative Molecular Analysis of Individual Radiosensitivity Among a Population of Pediatric Patients Treated With Radiation in Eastern France.
Verified date | February 2021 |
Source | Institut de Cancérologie de Lorraine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to explore prospectively the distribution of individual radiosensitivity in the pediatric population and to determine the predictive power of individual radiosensitivity biomarkers from an immunofluorescence technique on primary dermal fibroblasts
Status | Terminated |
Enrollment | 40 |
Est. completion date | February 7, 2020 |
Est. primary completion date | February 7, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility | Inclusion Criteria: - Children < 18 years old - Patient with an indication of radiotherapy - Patient must be affiliated to a social security system - Patient under parental autority - Ability to provide an informed written consent form Exclusion Criteria: - Contraindications for skin biopsy - Contraindications for radiotherapy - Referred to palliative radiotherapy - Prior radiotherapy in the same area - Indication of hypofractionated radiotherapy - Patient monitoring impossible - Patients deprived of liberty or under supervision |
Country | Name | City | State |
---|---|---|---|
France | CHU de Besançon | Besançon | |
France | CHU de Dijon | Dijon | |
France | Georges-François-Leclerc | Dijon | |
France | Centre Léon Bérard | Lyon | |
France | CHU de Reims | Reims | |
France | Centre Paul Strauss | Strasbourg | |
France | Hôpital de Hautepierre | Strasbourg | |
France | CHRU toulouse | Toulouse | |
France | IUCT Oncopole | Toulouse | |
France | CHRU Nancy | Vandoeuvre-lès-Nancy | |
France | Institut de Cancérologie de Lorraine | Vandoeuvre-lès-Nancy |
Lead Sponsor | Collaborator |
---|---|
Institut de Cancérologie de Lorraine |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | skin fibroblast radiosenstivity | residual double-strand breaks 24h after ex vivo radiation assessed with indirect immunofluorescence (gammaH2AX marker). | up to 5 months | |
Secondary | early cutaneous, mucosal and hematological early radiation toxicity | early radiation toxicity pattern assessed according to CTACAE v4.0 scale | 3 months | |
Secondary | pATM nucleoshuttling | pATM foci counted 10 minutes and 1 hour after ex vivo radiation assessed with indirect immunofluorescence (pATM marker). | up to 5 months | |
Secondary | mean micronuclei number | micronuclei counted 24 hours after ex vivo radiation assessed with indirect immunofluorescence (DAPI marker). | up to 5 months | |
Secondary | late radiation toxicity | deterministic tissue effects as well as secondary malignancies occurring in radiation field more than 3 months and up to 15 years after RT, using CTCAE v4.0 scale | 15 years |
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