Research of Biomarkers in Parkinson Disease (Genepark)

This study has been completed.
Sponsor:
Collaborator:
European Union
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT00465790
First received: April 23, 2007
Last updated: September 26, 2012
Last verified: December 2011
  Purpose

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.


Condition Phase
Parkinson Disease
Multiple System Atrophy
Progressive Supranuclear Palsy
Huntington Disease
Dystonia
Diffuse Lewy Body Disease
Phase 0

Study Type: Observational
Official Title: GENomic Biomarkers for PARKinson's Disease

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Enrollment: 219
Study Start Date: October 2007
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Employ innovative haemogenomic approaches to determine gene expression signatures specific for idiopathic Parkinson's disease (PD). There is currently no specific clinical or laboratory diagnostic test available for PD. In GENEPARK, blood samples from patients with genetic PD and idiopathic PD will be analysed by microarrays to identify gene expression signatures specific for PD. The specificity of the new biomarkers for PD will be tested by the analysis of patients with atypical parkinsonisms, including multiple system atrophy (MSA), progressive supranuclear palsy (PSP) and diffuse Lewy body disease (DLBD), as well as in patients with other basal ganglia disorders such as Huntington's disease (HD) and dopa responsive dystonia (DRD). The validated gene expression signatures will be utilised to develop a new test for diagnosis of idiopathic PD. Determine correlation between gene expression signatures and different stages of PD.

Gene expression in presymptomatic and symptomatic patients with genetic forms of PD as well as patients in various stages of idiopathic PD will be analysed to identify gene expression signatures specific for various stages of the disease. It should be emphasised that since no clinical measures are present in presymptomatic genetic PD such molecular markers could serve as surrogate markers to monitor therapeutic efficacy of possible preventive treatments in PD. Determine correlations between gene expression signatures and morphological evidence of neurodegenerative process in PD brain as determined by neuroimaging. Gene expression signatures identified in blood samples will be correlated with changes in brain as detected by neuroimaging in PD patients. Such correlations of molecular and morphological markers of disease will facilitate the selection of blood markers in relation to disease progression. Moreover, molecular and morphological markers of disease progression could be utilised in combination for monitoring the effects of new neuroprotective therapies for PD. Develop standardised approaches to development and validation of haemogenomic biomarkers.

This objective will be achieved by the special emphasis on careful clinical selection of patients, sufficient power regarding patient numbers, as well as extensive quality control and validation of the data. Develop new bioinformatic software tools for selection of genomic biomarkers using microarray data. The aim of the GENEPARK is to develop the theoretical foundations and to build the software tools for sample classification and selection of genomic biomarkers using microarray data. The established computational tools and novel methods developed within the GENEPARK will be applied to the patient data to study advantages and limitations of different methodologies.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with Parkinson's disease and related

Criteria

Inclusion Criteria:

  • Diagnosis of Parkinson's disease
  • Ability to understand the aim of the study
  • Ability to sign the consent form

Exclusion Criteria:

  • Non ability to understand the aim of the study
  • Non ability to sign the consent form
  • To be over 18
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00465790

Locations
Croatia
Meditterranean Institute for Life Sciences
Split, Croatia
France
INSERM Unit 679
Paris, France, 75013
Germany
University of Lübeck and Neuroimage Nord
Lübeck, Germany
University Hospital Tübingen
Tübingen, Germany
Slovenia
University Medical Center Ljubljana
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
European Union
Investigators
Principal Investigator: Borut Perterlin, MD, PhD University Medical Centre Ljubljana
  More Information

Additional Information:
No publications provided

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT00465790     History of Changes
Other Study ID Numbers: C06-56, 2007-A00208-45
Study First Received: April 23, 2007
Last Updated: September 26, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
biomarkers
neuroimaging
genetics
PET
Genetic and Idiopathic Parkinson
Multiple Systemic Atrophy
Huntington
Dopa Responsive Dystonia

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Huntington Disease
Parkinson Disease
Multiple System Atrophy
Shy-Drager Syndrome
Supranuclear Palsy, Progressive
Atrophy
Lewy Body Disease
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Basal Ganglia Diseases
Brain Diseases
Dementia
Chorea
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Parkinsonian Disorders
Primary Dysautonomias
Autonomic Nervous System Diseases
Hypotension
Vascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014