Parkinson's DiseaseNCT00855556
Parkinson's Disease Genetics Database
An observational study of Parkinson's Disease, run by Northwell Health at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- blood draw
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with a diagnosis of Parkinson's Disease as determined by standard neurological criteria.
Who may be able to join
- 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.
Who cannot join
- Patients without a diagnosis of Parkinson's Disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Feinstein Institute for Medical Research
Manhasset, New York, 11030
About this study
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).
- 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.
- To create a database with clinical, genetic (HLA, genome screen) and medical history information that will facilitate the search for PD susceptibility genes.
- To provide a centralized DNA repository to allow for targeted studies of genetic factors contributing to the onset, heterogeneity and progression of PD.
- To evaluate opportunities to extend the results of research to develop methods of risk prediction, prevention and therapy for PD.
- Conditions
- Parkinson's Disease
- Being tested
- blood draw
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawGenetic
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:
- 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.
- 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.
- No fasting, activity or medication restrictions are required prior to or following blood collection.
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
the current protocol is for establishment of the registry only and not for particular analyses of its contents
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2009 (estimated)
- Study startFeb 2008
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: Enrollment into this registry was not as robust as investigator envisioned. Thus, the registry was closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Pourfar, Northwell Health
- Investigators
- Michael Pourfar, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855556
- Sponsor's protocol ID
- GCRC 0171
- Status last verified
- Sep 2015
- First submitted
- 25 Feb 2009
- Last updated
- 16 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parkinson's Disease Genetics Database
- ClinicalTrials.gov ID
- NCT00855556
- Acronym / sponsor ID
- GCRC 0171
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Enrollment into this registry was not as robust as investigator envisioned. Thus, the registry was closed.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 4 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
- 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.
- To create a database with clinical, genetic (HLA, genome screen) and medical history information that will facilitate the search for PD susceptibility genes.
- To provide a centralized DNA repository to allow for targeted studies of genetic factors contributing to the onset, heterogeneity and progression of PD.
- To evaluate opportunities to extend the results of research to develop methods of risk prediction, prevention and therapy for PD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with a diagnosis of Parkinson's Disease as determined by standard neurological criteria.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients without a diagnosis of Parkinson's Disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood drawThe 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. | Genetic | – |
Primary outcome
the current protocol is for establishment of the registry only and not for particular analyses of its contents
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Enrollment into this registry was not as robust as investigator envisioned. Thus, the registry was closed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Pourfar, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Enrollment into this registry was not as robust as investigator envisioned. Thus, the registry was closed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the current protocol is for establishment of the registry only and not for particular analyses of its contents (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2015.