Идёт набор NCT02417324

International HIT-MED Registry (I-HIT-MED)

— Наблюдательное Childhood Brain Tumor

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: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Childhood Brain Tumor. 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: Германия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

International HIT-MED Registry (I-HIT-MED) for Children, Adolescents, and Adults With Medulloblastoma, Ependymoma, Pineoblastoma, CNS-primitive Neuroectodermal Tumours

Обзор

The I-HIT-MED registry registers clinical of children and adults with medulloblastoma, ependymoma, pineal tumours, or choroid plexus tumours in Germany and other countries that fulfil national ethic requirements for participation in this registry. These tumours are rare diseases, and many patients are treated outside of clinical trials. The I-HIT-MED registry allows collection of data und biological material from those patients, and provides a basis for standard treatment recommendations and counselling. It aims to improve the international cooperation and the medical knowledge in these rare diseases. Within the I-HIT-MED registry, it is a goal to maintain and improve networks for quality assurance in national groups where they are already established, and to support the implementation in national groups, where there is no quality assurance network yet.

Подробное описание

The following patients can be included in this registry:

Children and adults with

* Medulloblastoma (MB) * Ependymoma * Pineal Tumours * Chroroid plexus tumours

Objectives of this registry:

To prospectively evaluate the clinical courses of patients with the eligible brain tumours, considering neuroradiological, pathological, and molecular / biological characteristics of the tumour and individual standard treatment data.

To collect biological specimens (tumour, CSF, peripheral blood) or their data to perform biological studies on

* disease aetiology * molecular / biological risk factors influencing treatment response and survival * potential targets for drug treatment in future patients

To assess the use of systems for quality assurance during diagnosis and treatment of brain tumours.

To assess long-term follow-up, quality of survival, neuropsychology, and other patient-centred research in these very rare tumour subtypes in the context of the registry or in cooperation with external collaborators.

Первичные конечные точки

Event free survival [Срок оценки: 10 years]

Вторичные конечные точки (2)

Pattern of relapse [Срок оценки: 10 years]
Overall survival [Срок оценки: 10 years]

Критерии участия

Критерии включения

all patients with above mentioned diagnosis of all ages (except for ependymoma WHO I°, pineal parenchymal tumour of intermediate differentiation and papillary tumour of the pineal region, who will be registered only if primary diagnosis was before the 18th birthday)
any localisation of the primary tumour
all clinical stages
First diagnosis after 01.01.2012
No inclusion into a prospective clinical trial for the same diagnosis, due to non-eligibility, national lack of trial approval, or individual refusal of participation.
Written informed consent for data transfer and tumour sample submission according to the laws of each participating country is necessary.
National and/ or local ethical committee approval according to the laws of each participating country is necessary.