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Trial Title:
Longitudinal Investigation of Hippocampal Function and Morphology in Acute Lymphatic Leukemia (ALL) Patients Treated With Chemotherapy
NCT ID:
NCT01111396
Condition:
Acute Lymphatic Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Lymphoid
Conditions: Keywords:
ALL
GMALL 2003
Chemotherapy
Hippocampus
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
40 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Dresden University of Technology University Hospital
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Moritz Brandt, MD
Phone:
+49-351-458
Phone ext:
18507
Email:
moritz.brandt@uniklinikum-dresden.de
Contact backup:
Last name:
Kalina Brandt
Phone:
+49-351-458
Phone ext:
2610
Email:
kalina.brandt@uniklinikum-dresden.de
Investigator:
Last name:
Kalina Brandt
Email:
Sub-Investigator
Investigator:
Last name:
Moritz Brandt, MD
Email:
Sub-Investigator
Investigator:
Last name:
Martin Bornhaeuser, MD
Email:
Sub-Investigator
Investigator:
Last name:
Alexander Storch, MD
Email:
Principal Investigator
Investigator:
Last name:
Annett Werner, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Markus Schaich, MD
Email:
Sub-Investigator
Start date:
February 2010
Lead sponsor:
Agency:
Technische Universität Dresden
Agency class:
Other
Collaborator:
Agency:
Martin-Luther-Universität Halle-Wittenberg
Agency class:
Other
Source:
Technische Universität Dresden
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01111396
