NCT00465790

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

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
219

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2007

Longer than P75 for all trials

Geographic Reach
4 countries

5 active sites

Status
completed

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

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2007

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

September 27, 2012

Status Verified

December 1, 2011

Enrollment Period

4.7 years

First QC Date

April 23, 2007

Last Update Submit

September 26, 2012

Conditions

Keywords

biomarkersneuroimaginggeneticsPETGenetic and Idiopathic ParkinsonMultiple Systemic AtrophyHuntingtonDopa Responsive Dystonia

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

INSERM Unit 679

Paris, 75013, France

Location

University of Lübeck and Neuroimage Nord

Lübeck, Germany

Location

University Hospital Tübingen

Tübingen, Germany

Location

University Medical Center Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Links

MeSH Terms

Conditions

Parkinson DiseaseMultiple System AtrophySupranuclear Palsy, ProgressiveHuntington DiseaseDystoniaLewy Body DiseaseDystonia, Dopa-responsive

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesPrimary DysautonomiasAutonomic Nervous System DiseasesOphthalmoplegiaOcular Motility DisordersCranial Nerve DiseasesTauopathiesParalysisNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDementiaChoreaDyskinesiasHeredodegenerative Disorders, Nervous SystemGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Borut Perterlin, MD, PhD

    University Medical Centre Ljubljana

    PRINCIPAL INVESTIGATOR

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

Locations