Longitudinal Investigation of Hippocampal Function and Morphology in Acute Lymphatic Leukemia (ALL) Patients Treated With Chemotherapy
HIF-ALL
1 other identifier
observational
10
1 country
1
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.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 31, 2010
CompletedFirst Posted
Study publicly available on registry
April 27, 2010
CompletedApril 27, 2010
April 1, 2010
March 31, 2010
April 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Hippocampal function measured with virtual water maze test
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
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
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
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
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
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
Secondary Outcomes (22)
Hippocampal morphology measured by MRI
day 0
Hippocampal morphology measured by MRI
day 29
Hippocampal morphology measured by MRI
day 70
Hippocampal morphology measured by MRI
week 36
Peripheral blood cell count
day 0
- +17 more secondary outcomes
Study Arms (1)
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Neuropsychiatric disorders
- Present contraindication for MRI investigation (e.g. pacemaker)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dresden University of Technology University Hospital
Dresden, 01307, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander Storch, MD
Technische Universität Dresden
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 31, 2010
First Posted
April 27, 2010
Study Start
February 1, 2010
Last Updated
April 27, 2010
Record last verified: 2010-04