이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2010년 4월 26일 업데이트: 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.

연구 개요

상태

알려지지 않은

정황

급성림프성백혈병

연구 유형

관찰

등록 (예상)

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Moritz Brandt, MD
전화번호: 18507 +49-351-458
이메일: moritz.brandt@uniklinikum-dresden.de

연구 연락처 백업

이름: Kalina Brandt, MD
전화번호: 2610 +49-351-458
이메일: kalina.brandt@uniklinikum-dresden.de

연구 장소

독일
- - Dresden, 독일, 01307
    - 모병
    - Dresden University of Technology University Hospital
    - 연락하다:
      
      Moritz Brandt, MD
      
      전화번호: 18507 +49-351-458
      
      이메일: moritz.brandt@uniklinikum-dresden.de
    - 연락하다:
      
      Kalina Brandt
      
      전화번호: 2610 +49-351-458
      
      이메일: kalina.brandt@uniklinikum-dresden.de
    - 부수사관:
      
      Kalina Brandt
    - 부수사관:
      
      Moritz Brandt, MD
    - 부수사관:
      
      Martin Bornhaeuser, MD
    - 수석 연구원:
      
      Alexander Storch, MD
    - 부수사관:
      
      Annett Werner, PhD
    - 부수사관:
      
      Markus Schaich, MD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

그룹/코호트 수

코호트 및 개입

그룹/코호트
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Hippocampal function measured with virtual water maze test 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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

2차 결과 측정

결과 측정	측정값 설명	기간
Hippocampal morphology measured by MRI 기간: day 0		day 0
Hippocampal morphology measured by MRI 기간: day 29		day 29
Hippocampal morphology measured by MRI 기간: day 70		day 70
Hippocampal morphology measured by MRI 기간: week 36		week 36
Peripheral blood cell count 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Technische Universität Dresden

협력자

Martin-Luther-Universität Halle-Wittenberg

수사관

수석 연구원: Alexander Storch, MD, Technische Universitat Dresden

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2010년 2월 1일

연구 등록 날짜

최초 제출

2010년 3월 31일

QC 기준을 충족하는 최초 제출

2010년 4월 26일

처음 게시됨 (추정)

2010년 4월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2010년 4월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2010년 4월 26일

마지막으로 확인됨

2010년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

EK153052009

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

급성림프성백혈병에 대한 임상 시험

Jens Bräunlich, MD

완전한

COPD의 급성 Hypercapnic 급성 악화에서 NHF

Acute Hypercapnic AECOPD에서 NHF의 안전성

독일