Solid Tumor in ChildrenRISK-NNCT03609112
Neurocognitive Risks in Children With Solid Tumors
An observational study of Solid Tumor in Children, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
The survival rate of children with cancer has improved significantly in recent years thanks to the progress of different therapies. The neurocognitive sequelae related to treatments and illness are more or less well known. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Solid Tumor in Children
- What is being tested?
- The WISC-V, The NEPSY-II and The Child Executive Function Evaluation Battery CEF
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2014to Sep 2025
- How long will I take part?
- 60 Months
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient aged 6 to 16 years and 11 months during the study period
Who may be able to join
- Patient aged 6 to 16 years and 11 months during the study period
- Type of pathology: solid tumor
- Place of treatment and follow-up: Gustave Roussy
- Minimum time from the end of the initial treatment:
- For patients who have not received treatment with methotrexate: 6 months
- For patients being treated with methotrexate: none
- Obtaining the non-opposition of parents / legal representatives
- Affiliation to a social security scheme.
Who cannot join
- Patients with other pathologies associated with mental retardation (autism, genetic syndrome ...)
- Patients lost to follow-up
- Deceased patients
- Patients treated for a pathology whose prognosis is involved in the very short term (infiltrating glioma of the brainstem, recurrence of the pathology during treatment)
- Non-French speaking patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Gustave Roussy
Villejuif, Val De Marne, 94805
Christelle DUFOUR, MD, +33 (0)1 42 11 42 11, christelle.dufour@gustaveroussy.fr
About this study
The survival rate of children with cancer has improved significantly in recent years thanks to the progress of different therapies. The neurocognitive sequelae related to treatments and illness are more or less well known. Four factors seem to be associated with neurocognitive sequelae: treatment, the tumor itself, environmental factors like the socio-economic status of parents and biological factors.
Main purpose of the study is to establish a score to assess the risk of neurocognitive sequelae in these children based on these factors (treatment, tumor, and environmental factors)
- Conditions
- Solid Tumor in Children
- Being tested
- The WISC-V, The NEPSY-II, The Child Executive Function Evaluation Battery CEF, The "CONNERS 3 long version", The "BRIEF"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The WISC-VOther
The WISC-V (Weschler, 2016) which is measured with several indices: Verbal Comprehension Index (VCI), Visual Spatial Index (VSI), Working Memory Index (WMI), Fluid Reasoning Index (FRI), Processing Speed Index (PSI), and Full Scale IS (FSIQ).
The NEPSY-IIOther
The NEPSY-II (Korkman et al., 2012). The Narrative Memory subtest is designed to assess verbal memory using organised language material.
The Child Executive Function Evaluation Battery CEFOther
The Child Executive Function Evaluation Battery CEF (Roy et al., 2021), which aims to evaluate the four main components of executive function (inhibition, working memory, flexibility and planning).
The "CONNERS 3 long version"Other
The " CONNERS 3 long version " (Conners, 2008), which assesses attentional skills by means of a questionnaire to be completed by parents.
The "BRIEF"Other
The 'BRIEF' (Gioia et al., 2013; parent version, teacher version), which is a behavioural evaluation inventory of executive functions completed by parents and teachers and which makes it possible to determine whether the child has, for example, difficulties with organisation, planning or behavioural regulation.
The "PEDS-QL quality of life"Other
The "PEDS-QL quality of life" (Tessier et al., 2009) that will be completed by the parents and the patient concerns the day to- day functioning of the child (in school, relationships to others, physical abilities and emotional state).
The 'fatigue' version of the PEDS-QL (Tessier et al., 2009: parent and child-adolescent version for the brain tumour cohort)Other
The 'fatigue' version of the PEDS-QL (Tessier et al., 2009: parent and child-adolescent version for the brain tumour cohort) which assesses fatigue in everyday life.
The Family Functioning Inventory FAD)Other
The Family Functioning Inventory FAD (Speranza et al., 2006) is used to assess the family functioning of the child and his/her family. The short version is used as an indicator of general functioning.
The 'fatigue' version of the PEDS-QL (Tessier et al., 2009: child version for the extra-cerebral tumour cohort)Other
The 'fatigue' version of the PEDS-QL (Tessier et al., 2009: child version for the extra-cerebral tumour cohort) which assesses fatigue in everyday life.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated for a brain tumor | As part of their usual follow-up, these patients have neuropsychological evaluations following their treatment. A complete neuropsychological evaluation will therefore be performed as part of their usual follow-up during the inclusion period of this study and only the data from this evaluation will be taken into account for the statistical analysis of this study. Receives: Other: The WISC-V; Other: The NEPSY-II; Other: The Child Executive Function Evaluation Battery CEF; Other: The "CONNERS 3 long version"; Other: The "BRIEF"; Other: The "PEDS-QL quality of life"; Other: The 'fatigue' version of the PEDS-QL (Tessier et al., 2009: parent and child-adolescent version for the brain tumour cohort); Other: The Family Functioning Inventory FAD) | |
| Patients treated for a non-cerebral tumor | A single neuropsychological assessment will be proposed to these patients after the end of treatment and during the inclusion period of this study. This evaluation will be carried out during a visit to Gustave Roussy as part of their usual follow-up. If on the occasion of this evaluation, cognitive disorders or psychological disorders were highlighted, a neuropsychological and / or psychological follow-up would be proposed. Receives: Other: The WISC-V; Other: The Child Executive Function Evaluation Battery CEF; Other: The "CONNERS 3 long version"; Other: The "BRIEF"; Other: The Family Functioning Inventory FAD); Other: The 'fatigue' version of the PEDS-QL (Tessier et al., 2009: child version for the extra-cerebral tumour cohort) | |
| Patients who received Methotrexate | Methotrexate is used in the treatment of certain brain tumors as in that of non-cerebral tumors. Some of these patients, particularly those who have had neurological complications with methotrexate, will already have longitudinal neuropsychological follow-up as part of their usual follow-up. For these patients, only one complete neuropsychological assessment will be performed during the inclusion period and will be considered for statistical analysis.
For patients in the course of treatment with methotrexate, during the period of inclusion of this study, a longitudinal follow-up will be carried out with neuropsychological evaluations close and successive at the time of their coming to Gustave Roussy within the usual framework of their care. Receives: Other: The WISC-V; Other: The Child Executive Function Evaluation Battery CEF; Other: The "CONNERS 3 long version"; Other: The "BRIEF"; Other: The Family Functioning Inventory FAD); Other: The 'fatigue' version of the PEDS-QL (Tessier et al., 2009: child version for the extra-cerebral tumour cohort) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive analysis of possible neurocognitive deficits according to the pathology and treatments received.
Measured: Up to 60 months
Univariate analysis to identify risk factors related to cognitive disorders.
Measured: Up to 60 months
Multiple regression analysis to determine the most significant risk factors and examine the interactions between these factors.
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Oct 2014
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor in ChildrenStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609112
- Sponsor's protocol ID
- 2014-A00924-43
- Other IDs
- 2014/2127
- Acronym
- RISK-N
- Status last verified
- Dec 2024
- First submitted
- 24 Jul 2018
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Risks in Children With Solid Tumors
- ClinicalTrials.gov ID
- NCT03609112
- Acronym / sponsor ID
- RISK-N / 2014-A00924-43
- Conditions
- Solid Tumor in Children
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 1 Aug 2018 (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.
The survival rate of children with cancer has improved significantly in recent years thanks to the progress of different therapies. The neurocognitive sequelae related to treatments and illness are more or less well known. Four factors seem to be associated with neurocognitive sequelae: treatment, the tumor itself, environmental factors like the socio-economic status of parents and biological factors.
Main purpose of the study is to establish a score to assess the risk of neurocognitive sequelae in these children based on these factors (treatment, tumor, and environmental factors)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients treated for a brain tumor | – | Other: The WISC-V, Other: The NEPSY-II, Other: The Child Executive Function Evaluation Battery CEF, Other: The "CONNERS 3 long version", Other: The "BRIEF", Other: The "PEDS-QL quality of life", Other: The 'fatigue' version of the PEDS-QL (Tessier et al., 2009: parent and child-adolescent version for the brain tumour cohort), Other: The Family Functioning Inventory FAD)As part of their usual follow-up, these patients have neuropsychological evaluations following their treatment. A complete neuropsychological evaluation will therefore be performed as part of their usual follow-up during the inclusion period of this study and only the data from this evaluation will be taken into account for the statistical analysis of this study. |
| Patients treated for a non-cerebral tumor | – | Other: The WISC-V, Other: The Child Executive Function Evaluation Battery CEF, Other: The "CONNERS 3 long version", Other: The "BRIEF", Other: The Family Functioning Inventory FAD), Other: The 'fatigue' version of the PEDS-QL (Tessier et al., 2009: child version for the extra-cerebral tumour cohort)A single neuropsychological assessment will be proposed to these patients after the end of treatment and during the inclusion period of this study. This evaluation will be carried out during a visit to Gustave Roussy as part of their usual follow-up. If on the occasion of this evaluation, cognitive disorders or psychological disorders were highlighted, a neuropsychological and / or psychological follow-up would be proposed. |
| Patients who received Methotrexate | – | Other: The WISC-V, Other: The Child Executive Function Evaluation Battery CEF, Other: The "CONNERS 3 long version", Other: The "BRIEF", Other: The Family Functioning Inventory FAD), Other: The 'fatigue' version of the PEDS-QL (Tessier et al., 2009: child version for the extra-cerebral tumour cohort)Methotrexate is used in the treatment of certain brain tumors as in that of non-cerebral tumors. Some of these patients, particularly those who have had neurological complications with methotrexate, will already have longitudinal neuropsychological follow-up as part of their usual follow-up. For these patients, only one complete neuropsychological assessment will be performed during the inclusion period and will be considered for statistical analysis. For patients in the course of treatment with methotrexate, during the period of inclusion of this study, a longitudinal follow-up will be carried out with neuropsychological evaluations close and successive at the time of their coming to Gustave Roussy within the usual framework of their care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient aged 6 to 16 years and 11 months during the study period
Key inclusion criteria (8 listed)
- Patient aged 6 to 16 years and 11 months during the study period
- Type of pathology: solid tumor
- Place of treatment and follow-up: Gustave Roussy
- Minimum time from the end of the initial treatment:
- For patients who have not received treatment with methotrexate: 6 months
Key exclusion criteria (5 listed)
- Patients with other pathologies associated with mental retardation (autism, genetic syndrome ...)
- Patients lost to follow-up
- Deceased patients
- Patients treated for a pathology whose prognosis is involved in the very short term (infiltrating glioma of the brainstem, recurrence of the pathology during treatment)
- Non-French speaking patients
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 |
|---|---|---|
| The WISC-VThe WISC-V (Weschler, 2016) which is measured with several indices: Verbal Comprehension Index (VCI), Visual Spatial Index (VSI), Working Memory Index (WMI), Fluid Reasoning Index (FRI), Processing Speed Index (PSI), and Full Scale IS (FSIQ). | Other | Patients treated for a brain tumor, Patients treated for a non-cerebral tumor, Patients who received Methotrexate |
| The NEPSY-IIThe NEPSY-II (Korkman et al., 2012). The Narrative Memory subtest is designed to assess verbal memory using organised language material. | Other | Patients treated for a brain tumor |
| The Child Executive Function Evaluation Battery CEFThe Child Executive Function Evaluation Battery CEF (Roy et al., 2021), which aims to evaluate the four main components of executive function (inhibition, working memory, flexibility and planning). | Other | Patients treated for a brain tumor, Patients treated for a non-cerebral tumor, Patients who received Methotrexate |
| The "CONNERS 3 long version"The " CONNERS 3 long version " (Conners, 2008), which assesses attentional skills by means of a questionnaire to be completed by parents. | Other | Patients treated for a brain tumor, Patients treated for a non-cerebral tumor, Patients who received Methotrexate |
| The "BRIEF"The 'BRIEF' (Gioia et al., 2013; parent version, teacher version), which is a behavioural evaluation inventory of executive functions completed by parents and teachers and which makes it possible to determine whether the child has, for example, difficulties with organisation, planning or behavioural regulation. | Other | Patients treated for a brain tumor, Patients treated for a non-cerebral tumor, Patients who received Methotrexate |
| The "PEDS-QL quality of life"The "PEDS-QL quality of life" (Tessier et al., 2009) that will be completed by the parents and the patient concerns the day to- day functioning of the child (in school, relationships to others, physical abilities and emotional state). | Other | Patients treated for a brain tumor |
| The 'fatigue' version of the PEDS-QL (Tessier et al., 2009: parent and child-adolescent version for the brain tumour cohort)The 'fatigue' version of the PEDS-QL (Tessier et al., 2009: parent and child-adolescent version for the brain tumour cohort) which assesses fatigue in everyday life. | Other | Patients treated for a brain tumor |
| The Family Functioning Inventory FAD)The Family Functioning Inventory FAD (Speranza et al., 2006) is used to assess the family functioning of the child and his/her family. The short version is used as an indicator of general functioning. | Other | Patients treated for a brain tumor, Patients treated for a non-cerebral tumor, Patients who received Methotrexate |
| The 'fatigue' version of the PEDS-QL (Tessier et al., 2009: child version for the extra-cerebral tumour cohort)The 'fatigue' version of the PEDS-QL (Tessier et al., 2009: child version for the extra-cerebral tumour cohort) which assesses fatigue in everyday life. | Other | Patients treated for a non-cerebral tumor, Patients who received Methotrexate |
Primary outcome
Descriptive analysis of possible neurocognitive deficits according to the pathology and treatments received.
Time frame: Up to 60 months
Univariate analysis to identify risk factors related to cognitive disorders.
Time frame: Up to 60 months
Multiple regression analysis to determine the most significant risk factors and examine the interactions between these factors.
Time frame: Up to 60 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 13 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor in Children, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site 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 8 inclusion and 5 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 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Christelle DUFOUR, MD (+33 (0)1 42 11 42 11, christelle.dufour@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive analysis of possible neurocognitive deficits according to the pathology and treatments received. (time frame: Up to 60 months). The study lists 3 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 13 Dec 2024.