Cancer-related Problem/ConditionARPEGE BioMNCT02827552
Description of Individual Radiosensitivity With Molecular Biomarkers in a Pediatric Oncology Population
A study testing skin biopsy in people with Cancer-related Problem/Condition, run by Institut de Cancérologie de Lorraine at 11 sites in France.
Trial summary
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 Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cancer-related Problem/Condition
- What is being tested?
- skin biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 11 sitesFrance
- Study dates
- 13 Mar 2017to 7 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
CHU de Besançon
Besançon, 25 000
CHU de Dijon
Dijon, 21 000
Georges-François-Leclerc
Dijon, 21 000
Centre Léon Bérard
Lyon, 69 000
CHU de Reims
Reims, 51 100
Centre Paul Strauss
Strasbourg, 67 065
Hôpital de Hautepierre
Strasbourg, 67 098
CHRU toulouse
Toulouse, 31059
IUCT Oncopole
Toulouse, 31059
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54 500
CHRU Nancy
Vandœuvre-lès-Nancy, 54500
About this study
Official title: Integrative Molecular Analysis of Individual Radiosensitivity Among a Population of Pediatric Patients Treated With Radiation in Eastern France.
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
Read the detailed description
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.
- Conditions
- Cancer-related Problem/Condition
- Being tested
- skin biopsy
- Keywords
- pediatric oncology, radiotherapy, radiosensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin biopsyOther
skin biopsy performed prior radiation to characterize in blind the individual radiosensitivity of the patient
| Study group | Role | What they receive |
|---|---|---|
| ARPEGE BioM | Other | N/A (not a randomized study) Receives: Other: skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin fibroblast radiosenstivity
residual double-strand breaks 24h after ex vivo radiation assessed with indirect immunofluorescence (gammaH2AX marker).
Measured: up to 5 months
Secondary outcomes (4)
early cutaneous, mucosal and hematological early radiation toxicity
early radiation toxicity pattern assessed according to CTACAE v4.0 scale
Measured: 3 months
pATM nucleoshuttling
pATM foci counted 10 minutes and 1 hour after ex vivo radiation assessed with indirect immunofluorescence (pATM marker).
Measured: up to 5 months
mean micronuclei number
micronuclei counted 24 hours after ex vivo radiation assessed with indirect immunofluorescence (DAPI marker).
Measured: up to 5 months
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
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start13 Mar 2017
- Primary completion7 Feb 2020
- Study completion7 Feb 2020
Why it stopped: The liquidation of our industrial partner NEOLYS Diagnostics, directly involved in the methodology of the study and a sub-optimal rate of inclusions which did not allow us to include all patient within the allotted time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer-related Problem/ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- VOGIN GUILLAUME, MD,PhD, Principal investigator, Institut de Cancérologie de LorraineBERNIER CHASTAGNER VALERIE, MD, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827552
- Sponsor's protocol ID
- 2015-A00975-44
- Acronym
- ARPEGE BioM
- Status last verified
- Feb 2021
- First submitted
- 6 Jul 2016
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bernier-Chastagner V, Hettal L, Gillon V, Fernandes L, Huin-Schohn C, Vazel M, Tosti P, Salleron J, Francois A, Cerimele E, Perreira S, Peiffert D, Chastagner P, Vogin G. Validation of a high performance functional assay for individual radiosensitivity in pediatric oncology: a prospective cohort study (ARPEGE). BMC Cancer. 2018 Jul 6;18(1):719. doi: 10.1186/s12885-018-4652-7.
PubMed 29976172
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Molecular Analysis of Individual Radiosensitivity Among a Population of Pediatric Patients Treated With Radiation in Eastern France.
- ClinicalTrials.gov ID
- NCT02827552
- Acronym / sponsor ID
- ARPEGE BioM / 2015-A00975-44
- Conditions
- Cancer-related Problem/Condition
- Keywords
- pediatric oncology, radiotherapy, radiosensitivity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The liquidation of our industrial partner NEOLYS Diagnostics, directly involved in the methodology of the study and a sub-optimal rate of inclusions which did not allow us to include all patient within the allotted time.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 7 Feb 2020 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARPEGE BioM | Other | Other: skin biopsyN/A (not a randomized study) |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Contraindications for skin biopsy
- Contraindications for radiotherapy
- Referred to palliative radiotherapy
- Prior radiotherapy in the same area
- Indication of hypofractionated radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skin biopsyskin biopsy performed prior radiation to characterize in blind the individual radiosensitivity of the patient | Other | ARPEGE BioM |
Primary outcome
skin fibroblast radiosenstivity
Time frame: up to 5 months
residual double-strand breaks 24h after ex vivo radiation assessed with indirect immunofluorescence (gammaH2AX marker).
4 secondary outcomes
early cutaneous, mucosal and hematological early radiation toxicity
Time frame: 3 months
pATM nucleoshuttling
Time frame: up to 5 months
mean micronuclei number
Time frame: up to 5 months
late radiation toxicity
Time frame: 15 years
Results and safety
The study was stopped early (reason given: The liquidation of our industrial partner NEOLYS Diagnostics, directly involved in the methodology of the study and a sub-optimal rate of inclusions which did not allow us to include all patient within the allotted time.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Derived from this study: PubMed 29976172Bernier-Chastagner V, Hettal L, Gillon V, Fernandes L, Huin-Schohn C, Vazel M, Tosti P, Salleron J, Francois A, Cerimele E, Perreira S, Peiffert D, Chastagner P, Vogin G. Validation of a high performance functional assay for individual radiosensitivity in pediatric oncology: a prospective cohort study (ARPEGE). BMC Cancer. 2018 Jul 6;18(1):719. doi: 10.1186/s12885-018-4652-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
VOGIN GUILLAUME, MD,PhD principal investigator
Institut de Cancérologie de Lorraine
BERNIER CHASTAGNER VALERIE, MD principal investigator
Institut de Cancérologie de Lorraine
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin biopsy in people with Cancer-related Problem/Condition, run by Institut de Cancérologie de Lorraine at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The liquidation of our industrial partner NEOLYS Diagnostics, directly involved in the methodology of the study and a sub-optimal rate of inclusions which did not allow us to include all patient within the allotted time.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skin fibroblast radiosenstivity (time frame: up to 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02827552, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.