Biomarker Discovery in Parkinson's Disease (DISCOVERY-PD)
|ClinicalTrials.gov Identifier: NCT02016092|
Recruitment Status : Unknown
Verified March 2016 by Birgitt Schuele, The Parkinson's Institute.
Recruitment status was: Active, not recruiting
First Posted : December 19, 2013
Last Update Posted : March 14, 2016
There are approximately one million Americans who live with Parkinson's disease with 50,000 new cases per year and this rate is expected to rise with an aging population. The underlying pathophysiology and disease understanding of PD still remains elusive due to a combination of disease complexity and lack of predictive capability of existing models.
The Berg Interrogative Biology™ discovery platform has demonstrated a unique capability in producing drug targets and biomarkers that truly represent a disease phenotype. It has been able to catalyze molecules now in late stage clinical trials in cancer and many pre-clinical candidate therapeutics and biomarkers in endocrinology and central nervous system (CNS) diseases. The platform is able to decipher normal versus disease signatures by integration of data sets from the genome, metabolome, proteome, and lipidome in an agnostic manner that is subjected to Bayesian Artificial Intelligence informatics. The resulting nodes are then put back into wet-lab validation before proceeding to proof-of-principle pre-clinical testing.
By utilizing clinical data and specimens obtained by the medical specialists at The Parkinson's Institute, along with Berg's Interrogative Biology™, this study aims to discover a disease biomarker enabling the creation of a diagnostic test for Parkinson's disease.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||400 participants|
|Observational Model:||Case Control|
|Official Title:||Proteomics, Metabolomics, Lipidomics and Genetic Analysis for Biomarker DISCOVERY in Parkinson's Disease|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||June 2016|
|Patients with Parkinson's disease|
- Biological markers of Parkinson's disease [ Time Frame: 18 months ]To identify biologic markers of Parkinson's Disease (PD) for use in diagnostic testing.
- Correlation between biologic markers and clinical features of PD [ Time Frame: 36 months ]To identify and investigate possible correlations between biologic markers and clinical features of PD.
Biospecimen Retention: Samples With DNA
Blood & Urine Specimen Collection: Up to 20mL of venous blood samples will be collected for plasma multi-omic analysis, as well as optional genetic, analyses.
Urine samples (~50ml) will be collected via sterile urine cup and transferred into appropriate urine tube for multi-omic analysis.
All Samples may be saved for future studies, if consented.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02016092
|United States, California|
|The Parkinson's Institute and Clinical Center|
|Sunnyvale, California, United States, 94085|