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

NCT ID: NCT01111396

Last Updated: 2010-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Brief Summary

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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

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Conditions

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Acute Lymphatic Leukemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Martin-Luther-Universität Halle-Wittenberg

OTHER

Sponsor Role collaborator

Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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Dresden University of Technology

Principal Investigators

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Alexander Storch, MD

Role: PRINCIPAL_INVESTIGATOR

Technische Universität Dresden

Locations

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Dresden University of Technology University Hospital

Dresden, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Moritz Brandt, MD

Role: CONTACT

+49-351-458 ext. 18507

Kalina Brandt, MD

Role: CONTACT

+49-351-458 ext. 2610

Facility Contacts

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Moritz Brandt, MD

Role: primary

+49-351-458 ext. 18507

Kalina Brandt

Role: backup

+49-351-458 ext. 2610

Other Identifiers

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EK153052009

Identifier Type: -

Identifier Source: org_study_id

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