Condition category
Cancer
Date applied
23/08/2007
Date assigned
23/08/2007
Last edited
01/10/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M. Klein

ORCID ID

Contact details

Department of Medical Psychology
D343
Vrije University Medical Centre
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 8432
m.klein@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NWOpilot01

Study information

Scientific title

Acronym

Study hypothesis

We hypothesise that a relationship is present between functional connectivity, network features and neurocognitive performance in Glioblastoma Multiforme (GBM) patients. We also expect treatment and recurrence of the tumour to lead to remodelling of the neuronosynaptic maps and network features (i.e. plasticity), and hypothesise that these dynamic changes correlate with improvements of cognition.

Ethics approval

Ethics approval received from ethics boards of two centres participating in the study:
1. Academic Medical Centre (AMC) Medisch Ethische Commissie, received on the 16th July 2007 (ref: MEC 07/134)
2. VU University Medical Center Medical Ethical Board, received on the 12th June 2007 (ref: 2007/108)

Study design

Multicentre, observational, case-control study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Condition

Glioblastoma multiforme, high grade Glioma

Intervention

Using prospective cognitive data and MEG recordings of ten newly diagnosed glioblastoma multiforme patients and ten glioblastoma multiforme patients with tumour recurrence we will investigate:
1. The impact of tumour- and treatment-related factors on functional connectivity and neural network features, and
2. The correlation between changes in these measures and cognitive function

If such treatment- and/or tumour-related cerebral plasticity and its correlation with cognition can be established in this pilot, future prospective studies will focus in more detail on:
1. The effects of different treatment modalities (e.g. less or more extensive surgery, radiotherapy), and
2. The contribution of tumour-related symptoms (e.g. epilepsy) and their treatment (e.g. anti-epileptic drugs) on neural network function and cognition

This knowledge will eventually assist in the guidance of clinical decision-making in these patients.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Main study parameters are neurocognitive functioning and Magnetoencephalogram (MEG)-measures (synchronisation likelihood and small-world features).

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/09/2007

Overall trial end date

01/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

For newly diagnosed patients:
1. Adult (greater than 18 years)
2. Radiologically suspected GBM prior to surgery
3. Histologically confirmed GBM after surgery
4. Treatment consisting of surgery followed by combined radiotherapy and chemotherapy
5. Written informed consent

For patients with GBM recurrence:
1. Adult (greater than 18 years)
2. Histologically confirmed GBM
3. Treatment consisting of surgery followed by chemotherapy
4. Written informed consent

For matched healthy controls:
1. Adult (greater than 18 years)
2. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

40

Participant exclusion criteria

For patient groups:
1. Use of centrally acting drugs, including corticosteroids, other than antiepileptic drugs
2. Psychiatric disease or symptoms
3. Insufficient mastery of the Dutch language
4. Inability to communicate adequately

For controls:
1. Use of centrally acting drugs (including analgesics)
2. Psychiatric disease or symptoms
3. Disorders of the central nervous system
4. Insufficient mastery of the Dutch language

Recruitment start date

01/09/2007

Recruitment end date

01/06/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of Medical Psychology, D343
Amsterdam
1081 BT
Netherlands

Sponsor information

Organisation

Vrije University Medical Centre (VUMC) (The Netherlands)

Sponsor details

Department of Medical Psychology
Amsterdam
1081 BT
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.vumc.nl/english/

Funders

Funder type

Hospital/treatment centre

Funder name

Vrije University Medical Centre (VUMC) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes