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Longitudinal Investigation of Hippocampal Function and Morphology in Acute Lymphatic Leukemia (ALL) Patients Treated With Chemotherapy (HIF-ALL)

26 апреля 2010 г. обновлено: Technische Universität Dresden

Longitudinal Investigation of Hippocampal Function and Morphology in ALL Patients Treated With Chemotherapy: A Monocentric, Interdisciplinary Pilot Study

There are two regions in the adult brain that exhibit neuronal stem and progenitor cells, generating new neurons postnatally and throughout adulthood. One is the so called subventricular zone the other is the dentate gyrus of the hippocampus. Adult neurogenesis is a physiological process representing an important functional impact for certain brain areas, especially the hippocampus. The hippocampal formation plays an important role in long-term memory and spatial navigation. Inhibition of adult neurogenesis in mice by chemotherapy or radiation is followed by significant deficits in hippocampal memory functions while hippocampus-independent memory is unaffected.

Clinical trials had shown that chemotherapy and brain radiation lead to cognitive dysfunction. However, the exact mechanisms underlying this phenomenon are still unidentified.

The aim of our study is to investigate, whether the inhibition of adult neural stem cell proliferation in the hippocampus by intrathecal chemotherapy and/or cerebral radiation is responsible for treatment induced memory deficits. We will investigate patients suffering from acute lymphatic leukaemia (ALL) that receive prophylactic intrathecal chemotherapy and brain irradiation. The study represents a longitudinal investigation including a virtual "humanized" version of the morris-water-maze to test hippocampus dependent spatial memory, as well as MR-imaging for morphological (volumetry) and biochemical (spectroscopy) data.

Обзор исследования

Статус

Неизвестный

Условия

Острый лимфатический лейкоз

Тип исследования

Наблюдательный

Регистрация (Ожидаемый)

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Имя: Moritz Brandt, MD
Номер телефона: 18507 +49-351-458
Электронная почта: moritz.brandt@uniklinikum-dresden.de

Учебное резервное копирование контактов

Имя: Kalina Brandt, MD
Номер телефона: 2610 +49-351-458
Электронная почта: kalina.brandt@uniklinikum-dresden.de

Места учебы

Германия
- - Dresden, Германия, 01307
    - Рекрутинг
    - Dresden University of Technology University Hospital
    - Контакт:
      
      Moritz Brandt, MD
      
      Номер телефона: 18507 +49-351-458
      
      Электронная почта: moritz.brandt@uniklinikum-dresden.de
    - Контакт:
      
      Kalina Brandt
      
      Номер телефона: 2610 +49-351-458
      
      Электронная почта: kalina.brandt@uniklinikum-dresden.de
    - Младший исследователь:
      
      Kalina Brandt
    - Младший исследователь:
      
      Moritz Brandt, MD
    - Младший исследователь:
      
      Martin Bornhaeuser, MD
    - Главный следователь:
      
      Alexander Storch, MD
    - Младший исследователь:
      
      Annett Werner, PhD
    - Младший исследователь:
      
      Markus Schaich, MD

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 40 лет (Взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Метод выборки

Невероятностная выборка

Исследуемая популяция

Consecutive patients of the Department of Internal Medicine at the Dresden University of Technology hospital, who are initially diagnosed of acute lymphatic leukemia (ALL) and included into the GMALL 2003 chemotherapy study. All treatment procedures and outcome measurements of the GMALL 2003 study (most importantly also the safety outcome measures) are regularly performed in the sub population of the present sub study. Inclusion and exclusion criteria are given below.

Описание

Inclusion Criteria:

Initial diagnosis of acute lymphatic leukaemia (ALL)
Treatment within the German Multicenter Adult ALL (GMALL 2003) therapy study
Age 18 to 40 years
Eligibility for performing study procedure
Informed consent

Exclusion Criteria:

Neuropsychiatric disorders
Present contraindication for MRI investigation (e.g. pacemaker)

Учебный план

В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Количество групп / когорт

Когорты и вмешательства

Группа / когорта
Patient with ALL under chemotherapy This group consists of patients with initial diagnosis of acute lymphatic leukemia (ALL), who are enrolled into the GMALL 2003 chemotherapy study. There is no change of the initial GMALL 2003 treatment protocol for the present study.

Что измеряет исследование?

Первичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Hippocampal function measured with virtual water maze test Временное ограничение: day 0	The hippocampal function will by studies in a longitudinal manner and thus we plan to measure the water maze test performance at several time points (time frames) of the study.	day 0
Hippocampal function measured with virtual water maze test Временное ограничение: day 9	The hippocampal function will by studies in a longitudinal manner and thus we plan to measure the water maze test performance at several time points (time frames) of the study.	day 9
Hippocampal function measured with virtual water maze test Временное ограничение: day 16	The hippocampal function will by studies in a longitudinal manner and thus we plan to measure the water maze test performance at several time points (time frames) of the study.	day 16
Hippocampal function measured with virtual water maze test Временное ограничение: day 52	The hippocampal function will by studies in a longitudinal manner and thus we plan to measure the water maze test performance at several time points (time frames) of the study.	day 52
Hippocampal function measured with virtual water maze test Временное ограничение: day 70	The hippocampal function will by studies in a longitudinal manner and thus we plan to measure the water maze test performance at several time points (time frames) of the study.	day 70
Hippocampal function measured with virtual water maze test Временное ограничение: week 36	The hippocampal function will by studies in a longitudinal manner and thus we plan to measure the water maze test performance at several time points (time frames) of the study.	week 36

Вторичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Hippocampal morphology measured by MRI Временное ограничение: day 0		day 0
Hippocampal morphology measured by MRI Временное ограничение: day 29		day 29
Hippocampal morphology measured by MRI Временное ограничение: day 70		day 70
Hippocampal morphology measured by MRI Временное ограничение: week 36		week 36
Peripheral blood cell count Временное ограничение: day 0	Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study. Peripheral blood cell counts for estimating the chemotherapy toxicity according to WHO criteria and the minimal residual disease activity.	day 0
Peripheral blood cell count Временное ограничение: day 26	Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study. Peripheral blood cell counts for estimating the chemotherapy toxicity according to WHO criteria and the minimal residual disease activity.	day 26
Peripheral blood cell count Временное ограничение: day 46	Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study. Peripheral blood cell counts for estimating the chemotherapy toxicity according to WHO criteria and the minimal residual disease activity.	day 46
Peripheral blood cell count Временное ограничение: day 71	Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study. Peripheral blood cell counts for estimating the chemotherapy toxicity according to WHO criteria and the minimal residual disease activity.	day 71
Peripheral blood cell count Временное ограничение: week 16	Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study. Peripheral blood cell counts for estimating the chemotherapy toxicity according to WHO criteria and the minimal residual disease activity.	week 16
Peripheral blood cell count Временное ограничение: week 22	Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study. Peripheral blood cell counts for estimating the chemotherapy toxicity according to WHO criteria and the minimal residual disease activity.	week 22
Peripheral blood cell count Временное ограничение: week 30	Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study. Peripheral blood cell counts for estimating the chemotherapy toxicity according to WHO criteria and the minimal residual disease activity.	week 30
Peripheral blood cell count Временное ограничение: week 41	Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study. Peripheral blood cell counts for estimating the chemotherapy toxicity according to WHO criteria and the minimal residual disease activity.	week 41
Peripheral blood count Временное ограничение: week 52	Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study. Peripheral blood cell counts for estimating the chemotherapy toxicity according to WHO criteria and the minimal residual disease activity.	week 52
Bone marrow examination Временное ограничение: day 0	Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study. Bone marrow examination is investigated to extimate minimal residual disease activity and chemotherapy toxicity according to WHO criteria.	day 0
Bone marrow examination Временное ограничение: day 26	Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study. Bone marrow examination is investigated to extimate minimal residual disease activity and chemotherapy toxicity according to WHO criteria.	day 26
Bone marrow examination Временное ограничение: day 46	Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study. Bone marrow examination is investigated to extimate minimal residual disease activity and chemotherapy toxicity according to WHO criteria.	day 46
Bone marrow examination Временное ограничение: day 71	Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study. Bone marrow examination is investigated to extimate minimal residual disease activity and chemotherapy toxicity according to WHO criteria.	day 71
Bone marrow examination Временное ограничение: week 16	Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study. Bone marrow examination is investigated to extimate minimal residual disease activity and chemotherapy toxicity according to WHO criteria.	week 16
Bone marrow examination Временное ограничение: week 22	Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study. Bone marrow examination is investigated to extimate minimal residual disease activity and chemotherapy toxicity according to WHO criteria.	week 22
Bone marrow examination Временное ограничение: week 30	Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study. Bone marrow examination is investigated to extimate minimal residual disease activity and chemotherapy toxicity according to WHO criteria.	week 30
Bone marrow examination Временное ограничение: week 41	Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study. Bone marrow examination is investigated to extimate minimal residual disease activity and chemotherapy toxicity according to WHO criteria.	week 41
Bone marrow examination Временное ограничение: week 52	Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study. Bone marrow examination is investigated to extimate minimal residual disease activity and chemotherapy toxicity according to WHO criteria.	week 52

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Technische Universität Dresden

Соавторы

Martin-Luther-Universität Halle-Wittenberg

Следователи

Главный следователь: Alexander Storch, MD, Technische Universitat Dresden

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 февраля 2010 г.

Даты регистрации исследования

Первый отправленный

31 марта 2010 г.

Впервые представлено, что соответствует критериям контроля качества

26 апреля 2010 г.

Первый опубликованный (Оценивать)

27 апреля 2010 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)