Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-02 @ 5:34 AM
Study NCT ID:
NCT00855556
Status:
TERMINATED
Last Update Posted:
2015-09-16
First Post:
2009-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parkinson's Disease Genetics Database
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA stored in TE buffer solution'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'whyStopped': 'Enrollment into this registry was not as robust as investigator envisioned. Thus, the registry was closed.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-15', 'studyFirstSubmitDate': '2009-02-25', 'studyFirstSubmitQcDate': '2009-03-03', 'lastUpdatePostDateStruct': {'date': '2015-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the current protocol is for establishment of the registry only and not for particular analyses of its contents', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "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).\n\n1. 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.\n2. To create a database with clinical, genetic (HLA, genome screen) and medical history information that will facilitate the search for PD susceptibility genes.\n3. To provide a centralized DNA repository to allow for targeted studies of genetic factors contributing to the onset, heterogeneity and progression of PD.\n4. To evaluate opportunities to extend the results of research to develop methods of risk prediction, prevention and therapy for PD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Subjects with a diagnosis of Parkinson's Disease as determined by standard neurological criteria.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects must have a diagnosis of Parkinson's Disease as determined by standard neurological criteria.\n* Patients ≥18 years of age who are able to provide informed consent\n* Patients ≥ 18 who are decisionally impaired for whom informed consent can be obtained by a legally authorized representative.\n\nExclusion Criteria:\n\n* Patients without a diagnosis of Parkinson's Disease."}, 'identificationModule': {'nctId': 'NCT00855556', 'briefTitle': "Parkinson's Disease Genetics Database", 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': "Parkinson's Disease Genetics Database", 'orgStudyIdInfo': {'id': 'GCRC 0171'}}, 'armsInterventionsModule': {'interventions': [{'name': 'blood draw', 'type': 'GENETIC', 'description': '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:\n\n1. 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.\n2. 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.\n3. No fasting, activity or medication restrictions are required prior to or following blood collection.\n4. 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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'The Feinstein Institute for Medical Research', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}], 'overallOfficials': [{'name': 'Michael Pourfar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwell Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael Pourfar', 'investigatorAffiliation': 'Northwell Health'}}}}