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Research of Biomarkers in Parkinson Disease (Genepark)

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ClinicalTrials.gov Identifier: NCT00465790
Recruitment Status : Completed
First Posted : April 25, 2007
Last Update Posted : September 27, 2012
Sponsor:
Collaborator:
European Union
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Tracking Information
First Submitted Date April 23, 2007
First Posted Date April 25, 2007
Last Update Posted Date September 27, 2012
Study Start Date October 2007
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00465790 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Research of Biomarkers in Parkinson Disease
Official Title GENomic Biomarkers for PARKinson's Disease
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.

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.

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with Parkinson's disease and related
Condition
  • Parkinson Disease
  • Multiple System Atrophy
  • Progressive Supranuclear Palsy
  • Huntington Disease
  • Dystonia
  • Diffuse Lewy Body Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 26, 2012)
219
Original Enrollment
 (submitted: April 24, 2007)
1150
Actual Study Completion Date June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Croatia,   France,   Germany,   Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number NCT00465790
Other Study ID Numbers C06-56
2007-A00208-45
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Institut National de la Santé Et de la Recherche Médicale, France
Study Sponsor Institut National de la Santé Et de la Recherche Médicale, France
Collaborators European Union
Investigators
Principal Investigator: Borut Perterlin, MD, PhD University Medical Centre Ljubljana
PRS Account Institut National de la Santé Et de la Recherche Médicale, France
Verification Date December 2011