Child Cancer BrainMEDIRNCT01197924
MEDIR Medulloblastome
An observational study of Child Cancer Brain, run by University Hospital, Grenoble at 8 sites in France.
Trial summary
The medulloblastome is a tumour of the child relatively frequent usually sitting in the cerebellum and treated by surgery, radiotherapy and chemotherapy. After the treatment, these children present cognitive disorders and in particular disorders of the working memory associated with a fall with the school… Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Cancer Brain
- What is being tested?
- IRMf Bold
- How many people
- 80 participants
- Where
- 8 sitesFrance
- Study dates
- Oct 2007to Jul 2012
- Phase
- Observational
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: child Treaties for a médulloblastome after the 6 years age
Who may be able to join
- Old from 8 to 12 years
- Total IQ > 70 for the participation in the study and/or age développemental 7 years minimum
- Treaties for a médulloblastome after the 6 years age in remission supplements with 6 months a minimum time compared to the end of all the treatments
- Followed within the framework of the protocol of evaluation of the mnemic and attentionnelles after-effects
- Sensory after-effects compatible with the realization of the tasks and good performances at the time of the preceding drive the IRM
- Absence of counter-indication to the IRM
- Absence of catch of méthylphénidate (Ritaline®) for the treatment of disorders attentionnels 48h before the IRM
- Enlightened assent signed by at least one of the two parents or holders of the parental authority and by the child (minor)
Who cannot join
- Agitation or movements of the head at the time the IRM
- Artifacts of magnetic susceptibility in projection of the areas of interest (intracranial haemorrhage, cortical and/or metal remains post-operative) • Bad execution of the cognitive tasks
- Tumoral relapse in the course of protocol
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites, 8 recruiting
- Recruiting
University hospital
Bordeaux, Bordeaux, 33076
Michèle M ALLARD
Céline C BOUCHN ICHER
- Recruiting
UniversityHospitalGrenoble
Grenoble, 38043
Isabelle I SCHIFF, ISchiff@chu-grenoble.fr
Alexandre A KRAINIK
- Recruiting
Institut d'Hématologie et d'Oncologie Pédiatrique
Lyon, Lyon, 69008
Cécile c CONTER
DIDIER D FRAPPAZ
- Recruiting
Hôpital Frédéric Joliot Orsay - Hôpital Necker
Paris, Paris, 75015
Lucie L HERTZ PANNIER
Rodrigo R SEBASTIAN
- Recruiting
Institut Curie
Paris, Paris, 75231
Isabelle i AERTS
François F DOZ
- Recruiting
University Hospital
Saint-Etienne, Saint Etienne, 42055
CLAIRE C BERGER
FABRICE F BARRAL
- Recruiting
Institut Gutave Roussy
Villejuif, Villejuif, 94805
jacques j Grill
- Recruiting
SMAEC
Villeurbanne, Villeurbanne, 69100
Sybille S GONZALEZ
About this study
Official title: Médulloblastome of the Child and After-effects Cognitive: Study Anatomo-functional by IRM of the Working Memory
The medulloblastome is a tumour of the child relatively frequent usually sitting in the cerebellum and treated by surgery, radiotherapy and chemotherapy. After the treatment, these children present cognitive disorders and in particular disorders of the working memory associated with a fall with the school performances. By studying a troop of 32 children, we could show that the disorders of the working memory prevail during the handling of information presented visually and with verbal contents. However, the specific engagement of the cerebellum in the tasks of working memory according to the sensory method of presentation (visual or auditive) and the nature (verbal or not verbal) of information to treat vague remainder. Moreover, the anatomical attacks associated with these disorders remain ignored in these children. The best comprehension of the bases anatomo-functional calculuses which underlie their cognitive deficits is essential to develop new strategies of treatment and rehabilitation.
Objectives:
- To describe in IRMf of the common and specific networks engaged during the execution of the tasks of working memory according to the sensory type and the nature of information to be memorized.
- To describe in IRMf the cortical reorganizations necessary to the execution of the mnemic tasks among patients.
- To describe in anatomical IRM and of the tensor of diffusion lesions cérébelleuses and cerebral, cortical and subcortical associated with these disorders.
- To study the correlations radio-private clinics between data IRM and the data neurological and neuropsychological of the children explored according to protocol ONCORAP
Read the detailed description
The functional study should make it possible to show the specifically committed networks according to the cognitive tasks. Among patients, the relative difficulty to carry out the tasks of working memory should be accompanied by a recruitment of the dorso-side cortex préfrontal, lower and parietal frontal cortex but also of the median frontal areas such as the additional driving surface, the former cingulum. Moreover, one deterioration of the engagement of the cérébello-cerebral network (left lower parietal cortex and cérébelleux cortex lower right) facilitating the execution of these tasks should be observed.
- Conditions
- Child Cancer Brain
- Being tested
- IRMf Bold
- Keywords
- child cancer brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRMf BoldOther
IRMf BOLD of the working memory
| Study group | Role | What they receive |
|---|---|---|
| healthy volonteer children | paired for the sex and the age Receives: Other: IRMf Bold | |
| older children followed for a médulloblastome cérébelleux | children followed for a médulloblastome treaty by surgery, radiotherapy and chemotherapy Receives: Other: IRMf Bold |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startOct 2007
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Cancer BrainStudies 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
- Observational
- Observational model
- Case-control
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Investigators
- Anne A PAGNIER, Doctor, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197924
- Sponsor's protocol ID
- 07PHN01
- Acronym
- MEDIR
- Status last verified
- Sep 2010
- First submitted
- 7 Sep 2010
- Last updated
- 9 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Médulloblastome of the Child and After-effects Cognitive: Study Anatomo-functional by IRM of the Working Memory
- ClinicalTrials.gov ID
- NCT01197924
- Acronym / sponsor ID
- MEDIR / 07PHN01
- Conditions
- Child Cancer Brain
- Keywords
- child cancer brain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 9 Sep 2010 (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.
The medulloblastome is a tumour of the child relatively frequent usually sitting in the cerebellum and treated by surgery, radiotherapy and chemotherapy. After the treatment, these children present cognitive disorders and in particular disorders of the working memory associated with a fall with the school performances. By studying a troop of 32 children, we could show that the disorders of the working memory prevail during the handling of information presented visually and with verbal contents. However, the specific engagement of the cerebellum in the tasks of working memory according to the sensory method of presentation (visual or auditive) and the nature (verbal or not verbal) of information to treat vague remainder. Moreover, the anatomical attacks associated with these disorders remain ignored in these children. The best comprehension of the bases anatomo-functional calculuses which underlie their cognitive deficits is essential to develop new strategies of treatment and rehabilitation.
Objectives:
- To describe in IRMf of the common and specific networks engaged during the execution of the tasks of working memory according to the sensory type and the nature of information to be memorized.
- To describe in IRMf the cortical reorganizations necessary to the execution of the mnemic tasks among patients.
- To describe in anatomical IRM and of the tensor of diffusion lesions cérébelleuses and cerebral, cortical and subcortical associated with these disorders.
- To study the correlations radio-private clinics between data IRM and the data neurological and neuropsychological of the children explored according to protocol ONCORAP
Detailed description
The functional study should make it possible to show the specifically committed networks according to the cognitive tasks. Among patients, the relative difficulty to carry out the tasks of working memory should be accompanied by a recruitment of the dorso-side cortex préfrontal, lower and parietal frontal cortex but also of the median frontal areas such as the additional driving surface, the former cingulum. Moreover, one deterioration of the engagement of the cérébello-cerebral network (left lower parietal cortex and cérébelleux cortex lower right) facilitating the execution of these tasks should be observed.
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy volonteer children | – | Other: IRMf Boldpaired for the sex and the age |
| older children followed for a médulloblastome cérébelleux | – | Other: IRMf Boldchildren followed for a médulloblastome treaty by surgery, radiotherapy and chemotherapy |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- child Treaties for a médulloblastome after the 6 years age
Key inclusion criteria (8 listed)
- Old from 8 to 12 years
- Total IQ > 70 for the participation in the study and/or age développemental 7 years minimum
- Treaties for a médulloblastome after the 6 years age in remission supplements with 6 months a minimum time compared to the end of all the treatments
- Followed within the framework of the protocol of evaluation of the mnemic and attentionnelles after-effects
- Sensory after-effects compatible with the realization of the tasks and good performances at the time of the preceding drive the IRM
Key exclusion criteria (3 listed)
- Agitation or movements of the head at the time the IRM
- Artifacts of magnetic susceptibility in projection of the areas of interest (intracranial haemorrhage, cortical and/or metal remains post-operative) • Bad execution of the cognitive tasks
- Tumoral relapse in the course of protocol
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 |
|---|---|---|
| IRMf BoldIRMf BOLD of the working memory | Other | healthy volonteer children, older children followed for a médulloblastome cérébelleux |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2010.
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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.
Anne A PAGNIER, Doctor principal investigator
University Hospital, Grenoble
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Cancer Brain, run by University Hospital, Grenoble at 8 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 8 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabelle I SCHIFF (0476762635, ISchiff@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 9 Sep 2010.