Parkinson's Research: The Organized Genetics Initiative (PROGENI)
| Tracking Information | |||||
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| First Received Date ICMJE | June 22, 2004 | ||||
| Last Updated Date | February 15, 2011 | ||||
| Start Date ICMJE | August 1998 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00086073 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Parkinson's Research: The Organized Genetics Initiative | ||||
| Official Title ICMJE | Parkinson's Disease Collaborative Study of Genetic Linkage | ||||
| Brief Summary | The purpose of this trial is to study genetic and other risk factors that may be important in the development of Parkinson's disease. |
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| Detailed Description | The The Parkinson's Research: The Organized Genetics Initiative, also known as PROGENI, is a multi-center study involving 2000 people throughout North America who are affected, or possibly affected, with Parkinson's disease (PD). The goal of the initiative is to study the genetic and other risk factors which may be important in the development of PD. In order to better understand the genetic factors leading to PD, researchers will study families having 2 or more members diagnosed with PD. Using DNA samples from each participant, researchers hope to identify genes that may cause a person to be at higher risk for developing PD. Each participant in the study will be asked to complete a family history questionnaire, providing information about the history of PD in the family. Participants also will be asked to discuss the symptoms they have experienced and their responses to PD medications. This information will be used by study personnel to determine further eligibility for the study. Those eligible for further participation will be asked to undergo a study visit at the site closest to their residence, during which they will be asked to complete questionnaires regarding PD symptoms, medical history, places of residence, occupations, mood, mental status, and activity level. A blood sample will be drawn for DNA extraction. The study visit will take about 2 hours. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: blood sample |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | families having 2 or more members diagnosed with PD |
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| Condition ICMJE | Parkinson Disease | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 1800 | ||||
| Completion Date | January 2011 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Canada, Puerto Rico | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00086073 | ||||
| Other Study ID Numbers ICMJE | 9703-09, R01NS37167 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Tatiana Foroud, Ph.D, Principal Investigator, Indiana University | ||||
| Study Sponsor ICMJE | Indiana University School of Medicine | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Indiana University | ||||
| Verification Date | November 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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