Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-02-12 @ 8:36 PM
Study NCT ID:
NCT04919356
Status:
TERMINATED
Last Update Posted:
2023-01-18
First Post:
2021-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parkinson's Disease G2019S LRRK2 Genetic Testing Program
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Data generation using next-generation sequencing (NGS) of human exons'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 836}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Sponsor stopped the study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-16', 'studyFirstSubmitDate': '2021-06-04', 'studyFirstSubmitQcDate': '2021-06-04', 'lastUpdatePostDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Identify Parkinson's patients with the G2019S mutation in their LRRK2 gene", 'timeFrame': '2 years', 'description': "To identify Parkinson's patients with the G2019S mutation in their LRRK2 gene through whole exome sequencing in order to support the development of an oral precision medicine."}], 'secondaryOutcomes': [{'measure': "Understand the proportion of Parkinson's patients who have a G2019S LRRK2 mutation", 'timeFrame': '2 years', 'description': "To obtain information about the proportion of Parkinson's patients who have a G2019S LRRK2 mutation."}, {'measure': "Increase awareness of the importance of genetic testing in Parkinson's disease", 'timeFrame': '2 years', 'description': "To increase healthcare provider and patient awareness of the importance of genetic testing in Parkinson's disease in order to be aware of potential eligibility for clinical studies of genetic targeted medicines."}, {'measure': 'Increase interest of healthcare providers and patients participation in clinical trials', 'timeFrame': '2 years', 'description': "To engage healthcare providers and patients' interest in participation in upcoming clinical studies."}]}, 'conditionsModule': {'keywords': ['G2019S LRRK2 Mutation', 'Young Onset', 'Genetic', 'Ashkenazi Jewish Descent', 'North African Berber'], 'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'references': [{'pmid': '33836114', 'type': 'RESULT', 'citation': "Bright JM, Carlisle HJ, Toda AMA, Murphy M, Molitor TP, Wren P, Andruska KM, Liu E, Barlow C. Differential Inhibition of LRRK2 in Parkinson's Disease Patient Blood by a G2019S Selective LRRK2 Inhibitor. Mov Disord. 2021 Jun;36(6):1362-1371. doi: 10.1002/mds.28490. Epub 2021 Feb 11."}]}, 'descriptionModule': {'briefSummary': "Increase awareness of the G2019S LRRK2 mutation in Parkinson's and no cost genetic testing program.", 'detailedDescription': "This program is intended to increase awareness of genetic Parkinson's, in particular the G2019S LRRK2 mutation, and provide no cost genetic testing to determine if they carry the G2019S LRRK2 mutation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "A clinical diagnosis of Parkinson's disease", 'healthyVolunteers': False, 'eligibilityCriteria': "Participants include those with a clinical diagnosis of Parkinson's, in particular those who have a first- or second-degree relative with Parkinson's, or who have young onset Parkinson's (age less than 50 at diagnosis) or are of Ashkenazi Jewish or North African Berber descent, or have a relative with a known genetic mutation in the LRRK2 gene, or who have a genetic mutation in the LRRK2 gene.\n\nInclusion Criteria:\n\nParticipant eligible for enrollment in the program must meet all of the following criteria:\n\n1. Participant must be a person diagnosed with Parkinson's disease who is 18 years or older.\n2. Participant is under the care of a physician for their Parkinson's disease.\n3. Participant is able to read, write and understand English, and reside in a country where the shipment of biological samples is allowed.\n4. Participant is able to grant informed consent.\n5. In the case of participants, willing to participate in a free genetic testing program to determine if they carry the G2019S LRRK2 mutation.\n6. Willing to be notified of eligibility for clinical studies (if appropriate).\n7. Particpants who already believe they have tested positive for the mutation will be allowed to be retested through this program and be notified of potential eligibility for studies.\n\nExclusion Criteria:\n\n1. Inability to meet any of the inclusion criteria.\n2. Participant has received on of the following advanced treatments to manage their Parkinson's: gene therapy, deep brain stimulation (DBS), injections into the brain, continuous infusion of medication into their stomach/intestines with a pump."}, 'identificationModule': {'nctId': 'NCT04919356', 'briefTitle': "Parkinson's Disease G2019S LRRK2 Genetic Testing Program", 'organization': {'class': 'INDUSTRY', 'fullName': 'Escape Bio, Inc.'}, 'officialTitle': "G2019S LRRK2 Parkinson's Disease: Increasing Awareness and Genetic Testing Program", 'orgStudyIdInfo': {'id': 'G2019S-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'G2019S LRRK2', 'type': 'GENETIC', 'description': 'No cost genetic testing for G2019S LRRK2'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40299', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Eurofins Genomic LLC', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'overallOfficials': [{'name': 'Carrolee Barlow, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'ESCAPE Bio'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Escape Bio, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Engage Health Inc.', 'class': 'INDUSTRY'}, {'name': 'Sano', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}