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This is a prospective, open-label, multicentric study designed to correlate the dose delivered to the hippocampus with declarative memory deficits 2 years after radiotherapy treatment in a paediatric population who had received brain irradiation between the ages of 4 and 12 for a brain tumour.
In order to meet this objective, several neuropsychological assessments consisting of parental questionnaires and cognitive tests will be carried out during the course of the study, at the following two stages:
A retrospective assessment of the patient's neurocognitive level 1 year before the diagnosis of the disease will also be carried out at inclusion, with the parents completing a questionnaire specifically designed for the trial.
In addition, patients who have received their radiotherapy treatment at the IUCT-O will be offered participation in the ancillary imaging study. If the parents and the patient agree, multimodal MRI scans specific to the study (without injection of contrast) will be performed at inclusion and 2 years after inclusion.
Imaging and radiotherapy data will be collected in parallel using the PediaRT software used in current practice (collection of radiotherapy dosimetric data as well as standard MRI examinations pre-operatively, post-operatively, and at the 2-year and 4-year follow-up).
130 patients will be included in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with a brain tumour treated with radiotherapy in the first line 2 years prior to inclusion. | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuropsychological assessments: | Other | Several neuropsychological assessments were carried out during the study (at inclusion and 2 years after inclusion), consisting of :
Only for patients having received their radiotherapy treatment at the IUCT-O: a multimodal MRI specific to the study (without injection of contrast product) may be performed at inclusion and 2 years after inclusion. |
| Measure | Description | Time Frame |
|---|---|---|
| A deficit of the declarative memory will be defined by a standard score of the Children' Memory Scale (CMS) ≤ 5 | 24 months for each patient |
| Measure | Description | Time Frame |
|---|---|---|
| Declarative memory will be assessed using the adapted EPIREAL test. | 24 months for each patient | |
| Declarative memory will be assessed by the autobiographical memory question. | 24 months for each patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne LAPRIE | Contact | 05 31 15 54 43 | laprie.anne@iuct-oncopole.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Recruiting | Angers | France |
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|
| The deficit of the procedural memory will be defined by a score of less than or equal to 10/20 on the last 20 trials (out of 50) of the probabilistic classification task. | 24 months for each patient |
| The deficit of the procedural memory will be defined by a specific learning score less than or equal to zero of the adapted serial reaction time task (SRTT). | 24 months for each patient |
| Working memory deficit will be defined if at least one of the two subtests (Number memory (WISC-V) and Spatial memory (WNV)) shows a deficit. | For each subtest, a deficit will be defined respectively by a standard score ≤ 5 and a percentile rank ≤ 5. | 24 months for each patient |
| CHU de Bordeaux | Recruiting | Bordeaux | France |
|
| Centre François Baclesse | Recruiting | Caen | France |
|
| Centre Georges François Leclerc | Not yet recruiting | Dijon | France |
|
| Centre Oscar Lambret | Not yet recruiting | Lille | France |
|
| Centre Léon Bérard | Recruiting | Lyon | France |
|
| APHM - Hôpital la Timone | Not yet recruiting | Marseille | France |
|
| Institut du Cancer de Montpellier | Not yet recruiting | Montpellier | France |
|
| Institut Curie | Not yet recruiting | Paris | France |
|
| Centre Eugène Marquis | Not yet recruiting | Rennes | France |
|
| Institut de Cancérologie de l'Ouest | Not yet recruiting | Saint-Herblain | France |
|
| Centre Paul Strauss | Recruiting | Strasbourg | France |
|
| IUCT-O | Recruiting | Toulouse | France |
|
| Institut de Cancérologie de Lorraine | Recruiting | Vandœuvre-lès-Nancy | France |
|
| Institut Gustave Roussy | Recruiting | Villejuif | France |
|
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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