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Идёт набор NCT03609112

Neurocognitive Risks in Children With Solid Tumors

— Наблюдательное Solid Tumor in Children

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: The WISC-V, The NEPSY-II, The Child Executive Function Evaluation Battery CEF, The "CONNERS 3 long version".
Кому может быть актуально
Состояния в реестре: Solid Tumor in Children. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Обзор

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)

Вмешательства

  • Другое The WISC-V
    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).
  • Другое The NEPSY-II
    The NEPSY-II (Korkman et al., 2012). The Narrative Memory subtest is designed to assess verbal memory using organised language material.
  • Другое The Child Executive Function Evaluation Battery CEF
    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).
  • Другое 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.
  • Другое 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.
  • Другое 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).
  • Другое 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.
  • Другое 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.
  • Другое 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.

Первичные конечные точки

  • Descriptive analysis of possible neurocognitive deficits according to the pathology and treatments received. [Срок оценки: Up to 60 months]
  • Univariate analysis to identify risk factors related to cognitive disorders. [Срок оценки: Up to 60 months]
  • Multiple regression analysis to determine the most significant risk factors and examine the interactions between these factors. [Срок оценки: Up to 60 months]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Gustave Roussy — Villejuif

Идентификаторы

NCT: NCT03609112 · 2014-A00924-43 · 2014/2127

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗