Parkinson's Disease Genetics Database

This study has been terminated.
(Enrollment into this registry was not as robust as investigator envisioned. Thus, the registry was closed.)
Sponsor:
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00855556
First received: February 25, 2009
Last updated: September 8, 2011
Last verified: September 2011
  Purpose

The goal of the study is to develop and organize an effort to identify genes that determine an individual's risk for developing Parkinson's disease (PD).

  1. To ascertain, study and establish a repository of DNA samples that will allow for the identification of known and yet-to-be-identified genetic markers associated with the development of PD.
  2. To create a database with clinical, genetic (HLA, genome screen) and medical history information that will facilitate the search for PD susceptibility genes.
  3. To provide a centralized DNA repository to allow for targeted studies of genetic factors contributing to the onset, heterogeneity and progression of PD.
  4. To evaluate opportunities to extend the results of research to develop methods of risk prediction, prevention and therapy for PD.

Condition Intervention
Parkinson's Disease
Genetic: blood draw

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Parkinson's Disease Genetics Database

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • the current protocol is for establishment of the registry only and not for particular analyses of its contents [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

DNA stored in TE buffer solution


Enrollment: 16
Study Start Date: February 2008
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Genetic: blood draw

    The blood collection is designed to obtain blood samples as a source of DNA for genotyping and to establish a plasma and serum storage repository for future assays. GCRC nurses will perform all blood draws associated with this study. The following procedures are designed to standardize sample collection:

    1. Blood will be collected with the participant in the seated position with the reclining position reserved for those with a history of fainting during blood collection.
    2. Participants will be instructed to drink plenty of water (e.g., at least 8 large glasses of water) prior to the clinic visit as this facilitates easier collection.
    3. No fasting, activity or medication restrictions are required prior to or following blood collection.
    4. Blood collection will follow completion of the questionnaires. They will be performed by a nurse or technician with documented class time and experience in phlebotomy. Technician certification will occur prior to blood collection.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with a diagnosis of Parkinson's Disease as determined by standard neurological criteria.

Criteria

Inclusion Criteria:

  • Subjects must have a diagnosis of Parkinson's Disease as determined by standard neurological criteria.
  • Patients ≥18 years of age who are able to provide informed consent
  • Patients ≥ 18 who are decisionally impaired for whom informed consent can be obtained by a legally authorized representative.

Exclusion Criteria:

  • Patients without a diagnosis of Parkinson's Disease.
  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: NCT00855556

Locations
United States, New York
The Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Michael Pourfar, MD North Shore-LIJ Health System
  More Information

No publications provided

Responsible Party: North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00855556     History of Changes
Other Study ID Numbers: GCRC 0171
Study First Received: February 25, 2009
Last Updated: September 8, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on July 29, 2014