RadiosensitivityFOCUSONCT06033183
Integrative Molecular Analysis of Individual Radiosensitivity in Pediatric Oncology
A study testing Blood sample in people with Radiosensitivity and Pediatric Cancer, run by Neolys at 2 sites in France.
Trial summary
Analysis of the individual radiosensitivity in pediatric oncology Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Radiosensitivity, Pediatric Cancer, Radiation Toxicity
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 2 Dec 2023to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Minor patient treated for a brain tumor, Ewing tumor, malignant mesenchymal tumor, neuroblastoma, nephroblastoma, Hodgkin's lymphoma treated with radiotherapy (+/- chemotherapy) for curative purposes.
- Children or adolescents > 3 years old and < 18 years old
- Patient with an indication for radiotherapy as part of the primary tumor local control strategy
- Theoretical indication for radiotherapy in standard fractionation (1.8 Gy to 2.2 Gy / fraction: 5 fr/week) whatever the technique and the particle used
- Patient affiliated with a social security scheme
- Patient and/or parents or holders of parental authority having dated and signed an informed consent
Who cannot join
- Patients with contraindications to blood sampling
- Patients with contraindications to radiotherapy
- Palliative radiotherapy
- Patient with previous RT treatment in the same area (re-irradiation)
- Patient with an indication of hypofractionated RT
- Patient follow-up not possible
- Persons deprived of liberty or under guardianship (including curatorship)
- -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jennifer RUOS contact
France2 sites, 2 recruiting
- Recruiting
Centre François Baclesse
Caen
Fernand Missohou, MD
- Not yet recruiting
Centre Oscar Lambret
Lille
Xavier Mirabel, MD
About this study
Analysis of the individual radiosensitivity in pediatric oncology
- Conditions
- Radiosensitivity, Pediatric Cancer, Radiation Toxicity
- Being tested
- Blood sample
- Medical subject headings
- Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
Blood sample collection : 2 X 5 ml
| Study group | Role | What they receive |
|---|---|---|
| Radiosensitivity | Experimental | Patients who agree to participate in this research study will have blood sample collected to perform the RadioDtect test Receives: Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prospectively validate the discriminating capacities of the RadioDtect© individual radiosensitivity blood test on the occurrence of early radio-induced toxicities.
The validation will be based on ATM protein quantification assay to predict acute toxicities
Measured: 24 months
Prospectively validate the discriminating capacities of the RadioDtect© individual radiosensitivity blood test on the occurrence of early radio-induced toxicities.
evaluation of acute toxicities of grade ≥ 2 to 3 months according to NCI-CTCAE v4.03 criteria
Measured: 24 months
Secondary outcomes (2)
Prospectively validate the discriminating capacities of the RadioDtect individual radiosensitivity blood test protein assay according on the occurrence of late radiation-induced toxicity at 12 months
The validation will be based on ATM protein quantification assay to predict late toxicities
Measured: 12 months
Prospectively validate the discriminating capacities of the RadioDtect individual radiosensitivity blood test protein assay according on the occurrence of late radiation-induced toxicity at 12 months
evaluation of late toxicities of grade ≥ 2, according to NCI-CTCAE v4.03 criteria
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start2 Dec 2023
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiosensitivityStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neolys
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre Francois Baclesse, Centre Hospitalier Universitaire de Caen, Institut de cancérologie Strasbourg Europe, Centre Oscar Lambret, Lille, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033183
- Sponsor's protocol ID
- FOCUSO
- Acronym
- FOCUSO
- Status last verified
- Nov 2024
- First submitted
- 25 Aug 2023
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Molecular Analysis of Individual Radiosensitivity in Pediatric Oncology
- ClinicalTrials.gov ID
- NCT06033183
- Acronym / sponsor ID
- FOCUSO / FOCUSO
- Conditions
- Radiosensitivity, Pediatric Cancer, Radiation Toxicity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- NeolysIndustry (pharma, biotech, devices)
- Collaborators
- Centre Francois Baclesse, Centre Hospitalier Universitaire de Caen, Institut de cancérologie Strasbourg Europe, Centre Oscar Lambret, Lille, France
- Study start
- 2 Dec 2023 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 13 Sep 2023 (actual)
- 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.
Analysis of the individual radiosensitivity in pediatric oncology
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiosensitivity | Experimental | Biological: Blood samplePatients who agree to participate in this research study will have blood sample collected to perform the RadioDtect test |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Minor patient treated for a brain tumor, Ewing tumor, malignant mesenchymal tumor, neuroblastoma, nephroblastoma, Hodgkin's lymphoma treated with radiotherapy (+/- chemotherapy) for curative purposes.
- Children or adolescents > 3 years old and < 18 years old
- Patient with an indication for radiotherapy as part of the primary tumor local control strategy
- Theoretical indication for radiotherapy in standard fractionation (1.8 Gy to 2.2 Gy / fraction: 5 fr/week) whatever the technique and the particle used
- Patient affiliated with a social security scheme
Key exclusion criteria (8 listed)
- Patients with contraindications to blood sampling
- Patients with contraindications to radiotherapy
- Palliative radiotherapy
- Patient with previous RT treatment in the same area (re-irradiation)
- Patient with an indication of hypofractionated RT
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 |
|---|---|---|
| Blood sampleBlood sample collection : 2 X 5 ml | Biological | Radiosensitivity |
Primary outcome
Prospectively validate the discriminating capacities of the RadioDtect© individual radiosensitivity blood test on the occurrence of early radio-induced toxicities.
Time frame: 24 months
The validation will be based on ATM protein quantification assay to predict acute toxicities
Prospectively validate the discriminating capacities of the RadioDtect© individual radiosensitivity blood test on the occurrence of early radio-induced toxicities.
Time frame: 24 months
evaluation of acute toxicities of grade ≥ 2 to 3 months according to NCI-CTCAE v4.03 criteria
2 secondary outcomes
Prospectively validate the discriminating capacities of the RadioDtect individual radiosensitivity blood test protein assay according on the occurrence of late radiation-induced toxicity at 12 months
Time frame: 12 months
Prospectively validate the discriminating capacities of the RadioDtect individual radiosensitivity blood test protein assay according on the occurrence of late radiation-induced toxicity at 12 months
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
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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.
Jennifer RUOS contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Radiosensitivity and Pediatric Cancer, run by Neolys at 2 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandrine PEREIRA, PhD (0643957510, spereira@neolys-diagnostics.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prospectively validate the discriminating capacities of the RadioDtect© individual radiosensitivity blood test on the occurrence of early radio-induced toxicities. (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2024.