Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-28 @ 12:03 AM
Study NCT ID:
NCT04057794
Status:
UNKNOWN
Last Update Posted:
2023-07-14
First Post:
2019-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PDGeneration: Mapping the Future of Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}], 'ancestors': [{'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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-03', 'size': 296713, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-09-09T10:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All participants will undergo genetic counseling service post-genetic testing either locally or through central services.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1982}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2025-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-12', 'studyFirstSubmitDate': '2019-08-06', 'studyFirstSubmitQcDate': '2019-08-14', 'lastUpdatePostDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of genetic testing and counseling', 'timeFrame': 'up to 24 weeks', 'description': 'The total number of participants who receive genetic testing and counseling.'}, {'measure': 'Impact Evaluation', 'timeFrame': 'up to 6 months', 'description': "The impact of knowledge gained by people with Parkinson's by assessing returned survey responses regarding their behavior and follow-up to clinical care after receipt of genetic counseling."}, {'measure': 'Satisfaction Comparison', 'timeFrame': 'up to 6 months', 'description': 'Differences in satisfaction of receiving genetic test results and genetic counseling by enrolling site (clinician/genetic counselor) or centralized counseling group using the Clinical Genetic Counseling Satisfaction Score.'}], 'secondaryOutcomes': [{'measure': 'Number of participants that enroll in precision medicine trials', 'timeFrame': 'up to 12 months', 'description': 'Number of participants that enroll in precision medicine trials'}, {'measure': 'Time it takes between first contact to the return of genetic test results', 'timeFrame': 'up to 12 months', 'description': 'Number of weeks it takes between participant consent to return of genetic test results.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ["Parkinson's", 'Genetics', 'PD Genetics'], 'conditions': ["Parkinson's Disease and Parkinsonism"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.parkinson.org/PDGENEration', 'label': 'For more information and to enroll, please visit the website.'}]}, 'descriptionModule': {'briefSummary': "To assess the feasibility, impact, and participant satisfaction of offering Clinical Laboratory Improvement Amendments (CLIA) certified genetic testing as part of clinical care for People with Parkinson's disease (PWP).", 'detailedDescription': "The purpose of this study is to evaluate how offering Clinical Laboratory Improvement Amendments (CLIA) certified genetic testing for Parkinson's Disease (PD) genes to people with Parkinson's Disease impacts clinical care and potential enrollment in clinical trials. This multi-center study will assess the impact and satisfaction of the mode of genetic counseling by comparing counseling conducted by a clinician versus centralized genetic counseling conducted through Indiana University. The study will also assess knowledge gained by administering a knowledge survey pre- and post-genetic testing. All genetic test results will be returned to participants through a genetic counseling visit."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Meet Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease: probable diagnosis.\n2. Willingness to undergo genetic testing, and choose to be informed of genetic testing results for Glucosylceramidase Beta (GBA), LRRK2 and 5 additional PD related genes (SNCA, VPS35, PRKN, PINK-1, PARK7).\n3. Capacity to give full informed consent in writing, and have read and signed the informed consent forms (ICFs) based on clinician's determination.\n4. Able to perform study activities (including completion of either online, in-person or paper surveys).\n5. Individuals must speak and understand the language of the informed consent.\n\nExclusion Criteria:\n\n1. Diagnosis of an atypical parkinsonian disorder (i.e., multiple system atrophy, progressive supranuclear palsy, dementia with Lewy bodies, corticobasal syndrome), including that due to medications, metabolic disorders, encephalitis, cerebrovascular disease, or normal pressure hydrocephalus.\n2. Individuals who have received a blood transfusion within the past 3 months.\n3. Individuals who have active hematologic malignancies such as lymphoma or leukemia.\n4. Individuals who have had a bone marrow transplant within the past 5 years."}, 'identificationModule': {'nctId': 'NCT04057794', 'acronym': 'PDGENE', 'briefTitle': "PDGeneration: Mapping the Future of Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': "Parkinson's Foundation"}, 'officialTitle': "Parkinson's Foundation: PD Generation: Mapping the Future of Parkinson's Disease", 'orgStudyIdInfo': {'id': 'PDGene-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Site-Based Genetic Counseling', 'description': 'Participants randomized to this arm will receive genetic counseling for genetic results through the enrolling site.', 'interventionNames': ["Device: Lab Assay for seven genetic variants for Parkinson's Disease"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Centralized Genetic Counseling', 'description': 'Participants randomized to this arm will receive genetic counseling for genetic results through a centralized genetic counseling group at Indiana University.', 'interventionNames': ["Device: Lab Assay for seven genetic variants for Parkinson's Disease"]}], 'interventions': [{'name': "Lab Assay for seven genetic variants for Parkinson's Disease", 'type': 'DEVICE', 'description': 'Counseling provided to participant by site clinician/physician/genetic counselor.', 'armGroupLabels': ['Site-Based Genetic Counseling']}, {'name': "Lab Assay for seven genetic variants for Parkinson's Disease", 'type': 'DEVICE', 'description': 'Counseling provided to participant by centralized genetic counseling group at Indiana University.', 'armGroupLabels': ['Centralized Genetic Counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Barrow Neurological Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego (UCSD)', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'country': 'United States', 'facility': 'Cleveland Clinic Florida-Weston', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Feinberg School of Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '02129', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55427', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': "Health Partners/Park Nicollet: Struthers Parkinson's Center", 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Beth Israel Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Roy N Alcalay, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Parkinson's Foundation", 'class': 'OTHER'}, 'collaborators': [{'name': 'Fulgent Laboratories', 'class': 'UNKNOWN'}, {'name': 'Indiana University', 'class': 'OTHER'}, {'name': 'The Parkinson Study Group', 'class': 'NETWORK'}, {'name': 'Navitas Clinical Research, Inc', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}