Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01111396
Recruitment Status : Unknown
Verified April 2010 by Technische Universität Dresden.
Recruitment status was:  Recruiting
First Posted : April 27, 2010
Last Update Posted : April 27, 2010
Sponsor:
Collaborator:
Martin-Luther-Universität Halle-Wittenberg
Information provided by:
Technische Universität Dresden

Tracking Information
First Submitted Date March 31, 2010
First Posted Date April 27, 2010
Last Update Posted Date April 27, 2010
Study Start Date February 2010
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: April 26, 2010)
  • Hippocampal function measured with virtual water maze test [ Time Frame: 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.
  • Hippocampal function measured with virtual water maze test [ Time Frame: 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.
  • Hippocampal function measured with virtual water maze test [ Time Frame: 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.
  • Hippocampal function measured with virtual water maze test [ Time Frame: 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.
  • Hippocampal function measured with virtual water maze test [ Time Frame: 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.
  • Hippocampal function measured with virtual water maze test [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 26, 2010)
  • Hippocampal morphology measured by MRI [ Time Frame: day 0 ]
  • Hippocampal morphology measured by MRI [ Time Frame: day 29 ]
  • Hippocampal morphology measured by MRI [ Time Frame: day 70 ]
  • Hippocampal morphology measured by MRI [ Time Frame: week 36 ]
  • Peripheral blood cell count [ Time Frame: 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.
  • Peripheral blood cell count [ Time Frame: 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.
  • Peripheral blood cell count [ Time Frame: 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.
  • Peripheral blood cell count [ Time Frame: 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.
  • Peripheral blood cell count [ Time Frame: 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.
  • Peripheral blood cell count [ Time Frame: 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.
  • Peripheral blood cell count [ Time Frame: 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.
  • Peripheral blood cell count [ Time Frame: 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.
  • Peripheral blood count [ Time Frame: 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.
  • Bone marrow examination [ Time Frame: 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.
  • Bone marrow examination [ Time Frame: 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.
  • Bone marrow examination [ Time Frame: 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.
  • Bone marrow examination [ Time Frame: 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.
  • Bone marrow examination [ Time Frame: 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.
  • Bone marrow examination [ Time Frame: 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.
  • Bone marrow examination [ Time Frame: 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.
  • Bone marrow examination [ Time Frame: 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.
  • Bone marrow examination [ Time Frame: 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Longitudinal Investigation of Hippocampal Function and Morphology in Acute Lymphatic Leukemia (ALL) Patients Treated With Chemotherapy
Official Title Longitudinal Investigation of Hippocampal Function and Morphology in ALL Patients Treated With Chemotherapy: A Monocentric, Interdisciplinary Pilot Study
Brief Summary

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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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.
Condition Acute Lymphatic Leukemia
Intervention Not Provided
Study Groups/Cohorts 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 26, 2010)
10
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01111396
Other Study ID Numbers EK153052009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Professor Alexander Storch, MD, Dresden University of Technology
Study Sponsor Technische Universität Dresden
Collaborators Martin-Luther-Universität Halle-Wittenberg
Investigators
Principal Investigator: Alexander Storch, MD Technische Universität Dresden
PRS Account Technische Universität Dresden
Verification Date April 2010