Description of Individual Radiosensitivity With Molecular Biomarkers in a Pediatric Oncology Population (ARPEGE BioM)
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| ClinicalTrials.gov Identifier: NCT02827552 |
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Recruitment Status :
Recruiting
First Posted : July 11, 2016
Last Update Posted : December 4, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cancer-related Problem/Condition | Other: skin biopsy | Not Applicable |
900 children and adolescents benefit from radiation each year in France. The mean age at diagnosis is 5 years; life expectancy for the 80% of them who could cure is long, and the incidence of radiation-related acute and mainly late complications - not evaluated to date - could exceed that of adults. Dysfunction of irradiated organs and growth disorders are specific to the pediatric subpopulation. Individual radiosensitivity of children and adolescents is unknown at this time, probably with large variability depending on the age when considering the changes in metabolic functions throughout growth. These complications are largely attributable to inter individual constitutional variations of cellular response to DNA damage.
Subject to radiation-induced DNA damages such as double-strand breaks (DSB), cells reacts by triggering a whole series of phosphorylation events coordinated within multi protein complexes whose interplay is still misknown (DNA damage response i.e. DDR). Indirect Immunofluorescence cell scanning has revolutionized radiation biology research by permitting the detection of individual DSB in each cell nucleus in a dose range from 1 mGy to 10 Gy. This technique has notably confirmed that yield of unrepaired DSB is correlated with cell RS. From a broad spectrum of human radiosensitive skin fibroblast cell lines, the Inserm CRU 1052 team proposed a general model of DSB signaling and repair and a molecular assay to stratify patients according to their individual RS.
ARPEGE biomarqueurs is a prospective multicenter study to prospectively evaluate with this assay the RS of children and adolescents treated over a year in all pediatric oncology departments of the Region Grand Est and set thresholds in this population. 150 children are thus potentially includable in different centers. The assay will be performed on primary fibroblasts cultured from a skin biopsy taken at diagnosis. The RS of patients will be measured in blind. Confusion factors such as irradiated volume, skin phototype, previous chemotherapy regimen, smoking, comorbities (diabetes, immunodeficiency, chronic inflammatory disease ...) will be reported. In parallel the RT-acute toxicity will be reported according to NCI-CTCAE v4.0 reference scale three months of the completion of RT then periodically during 15 years.
Screening hypersensitive patients would be a major step forward in the management of cancers, opening a view to personalized medicine.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 222 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Integrative Molecular Analysis of Individual Radiosensitivity Among a Population of Pediatric Patients Treated With Radiation in Eastern France. |
| Actual Study Start Date : | March 13, 2017 |
| Estimated Primary Completion Date : | September 2021 |
| Estimated Study Completion Date : | September 2034 |
| Arm | Intervention/treatment |
|---|---|
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ARPEGE BioM
N/A (not a randomized study)
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Other: skin biopsy
skin biopsy performed prior radiation to characterize in blind the individual radiosensitivity of the patient |
- skin fibroblast radiosenstivity [ Time Frame: up to 5 months ]residual double-strand breaks 24h after ex vivo radiation assessed with indirect immunofluorescence (gammaH2AX marker).
- early cutaneous, mucosal and hematological early radiation toxicity [ Time Frame: 3 months ]early radiation toxicity pattern assessed according to CTACAE v4.0 scale
- pATM nucleoshuttling [ Time Frame: up to 5 months ]pATM foci counted 10 minutes and 1 hour after ex vivo radiation assessed with indirect immunofluorescence (pATM marker).
- mean micronuclei number [ Time Frame: up to 5 months ]micronuclei counted 24 hours after ex vivo radiation assessed with indirect immunofluorescence (DAPI marker).
- late radiation toxicity [ Time Frame: 15 years ]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
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| Ages Eligible for Study: | up to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02827552
| Contact: MERLIN JEAN LOUIS, PR | + 33 3 83 59 83 07 | jl.merlin@nancy.unicancer.fr | |
| Contact: TOSTI PRISCILLIA, PhD | + 33 3 83 59 86 57 | p.tosti@nancy.unicancer.fr |
| France | |
| CHU de Besançon | Recruiting |
| Besançon, France, 25 000 | |
| Contact: LAITHIER Véronique, MD vlaithier@chu-besancon.fr | |
| CHU de Dijon | Recruiting |
| Dijon, France, 21 000 | |
| Contact: BRIANDET Claire, MD claire.briandet@chu-dijon.fr | |
| Georges-François-Leclerc | Recruiting |
| Dijon, France, 21 000 | |
| Contact: TRUC Gilles, MD gtruc@cgfl.fr | |
| Centre Léon Bérard | Recruiting |
| Lyon, France, 69 000 | |
| Contact: CLAUDE Line, MD line.claude@lyon.unicancer.fr | |
| CHU de Reims | Recruiting |
| Reims, France, 51 100 | |
| Contact: PLUCHART Claire, MD cpluchart@chu-reims.fr | |
| Centre Paul Strauss | Recruiting |
| Strasbourg, France, 67 065 | |
| Contact: VIGNERON Céline, MD cvigneron@strasbourg.unicancer.fr | |
| Hôpital de Hautepierre | Recruiting |
| Strasbourg, France, 67 098 | |
| Contact: ENTZ-WERLE Natacha, MD natacha.entz-werle@chru-strasbourg.fr | |
| CHRU toulouse | Recruiting |
| Toulouse, France, 31059 | |
| Contact: GAMBART Marion, MD gambart.m@chu-toulouse.fr | |
| IUCT Oncopole | Recruiting |
| Toulouse, France, 31059 | |
| Contact: LAPRIE Anne, MD Laprie.Anne@iuct-oncopole.fr | |
| Contact: DUCASSOU Anne, M/D Ducassou.Anne@iuct-oncopole.fr | |
| Institut de Cancérologie de Lorraine | Recruiting |
| Vandoeuvre-lès-Nancy, France, 54 500 | |
| Contact: VOGIN Guillaume, MD g.vogin@nancy.unicancer.fr | |
| Contact: BERNIER CHASTAGNER Valérie, MD v.bernier@nancy.unicancer.fr | |
| CHRU Nancy | Recruiting |
| Vandoeuvre-lès-Nancy, France, 54500 | |
| Contact: CHASTAGNER Pascal, MD p.chastagner@chru-nancy.fr | |
| Principal Investigator: | VOGIN GUILLAUME, MD,PhD | Institut de Cancérologie de Lorraine | |
| Principal Investigator: | BERNIER CHASTAGNER VALERIE, MD | Institut de Cancérologie de Lorraine |
| Responsible Party: | Institut de Cancérologie de Lorraine |
| ClinicalTrials.gov Identifier: | NCT02827552 |
| Other Study ID Numbers: |
2015-A00975-44 |
| First Posted: | July 11, 2016 Key Record Dates |
| Last Update Posted: | December 4, 2019 |
| Last Verified: | December 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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pediatric oncology radiotherapy radiosensitivity |