Research of Biomarkers in Parkinson Disease
Genepark
GENomic Biomarkers for PARKinson's Disease
2 other identifiers
observational
219
4 countries
5
Brief Summary
The main goal of the GENEPARK consortium is to employ innovative haemogenomic approaches to determine gene expression profiles specific for genetic and idiopathic Parkinson's disease (PD) patients. These gene expression signatures will be utilised clinically as non-invasive diagnostic tests for PD. The sensitivity of the newly developed diagnostic test will be determined by extensive validations on an independent cohort of PD patients, whereas the specificity will be assessed by testing patients with atypical parkinsonisms, including multiple system atrophy, progressive supranuclear palsy and diffuse Lewy body disease. In order to test the specificity of the diagnostic set in other disorders that affect basal ganglia, Huntington's disease and dopa responsive dystonia patients will be analysed. The second objective of the proposal is to determine correlations between gene expression signatures and different stages of PD and thus provide the basis for early diagnosis and monitoring of disease progression. These changes in blood gene expression will be correlated with alterations detected by neuroimaging in the brain of PD patients. Such combinations of molecular and morphological markers of disease may ultimately facilitate the selection and monitoring of neuroprotective therapies for PD. Finally, GENEPARK aims to develop new bioinformatic software tools for selection of genomic biomarkers using microarray data. A set of established computational tools will be applied and novel methods, some of them based on mechanistic modelling of the neurodegenerative diseases, will be developed in order to study the advantages and limitations of the different methodologies. With special emphasis on the careful clinical selection of patients and sufficient power regarding patient numbers, as well as extensive quality control and validation of the data, GENEPARK aims to develop a standardised approach to development and validation of haemogenomic biomarkers of disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2007
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2007
CompletedFirst Posted
Study publicly available on registry
April 25, 2007
CompletedStudy Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedSeptember 27, 2012
December 1, 2011
4.7 years
April 23, 2007
September 26, 2012
Conditions
Keywords
Eligibility Criteria
Patients with Parkinson's disease and related
You may qualify if:
- Diagnosis of Parkinson's disease
- Ability to understand the aim of the study
- Ability to sign the consent form
You may not qualify if:
- Non ability to understand the aim of the study
- Non ability to sign the consent form
- To be over 18
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Meditterranean Institute for Life Sciences
Split, Croatia
INSERM Unit 679
Paris, 75013, France
University of Lübeck and Neuroimage Nord
Lübeck, Germany
University Hospital Tübingen
Tübingen, Germany
University Medical Center Ljubljana
Ljubljana, 1000, Slovenia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Borut Perterlin, MD, PhD
University Medical Centre Ljubljana
Study Design
- Study Type
- observational
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2007
First Posted
April 25, 2007
Study Start
October 1, 2007
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
September 27, 2012
Record last verified: 2011-12