Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
Study NCT ID:
NCT03523104
Status:
RECRUITING
Last Update Posted:
2018-05-29
First Post:
2018-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chinese PD-LRRK2 Registry
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': 'extraction of DNA from peripheral blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-24', 'studyFirstSubmitDate': '2018-05-01', 'studyFirstSubmitQcDate': '2018-05-01', 'lastUpdatePostDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Database of Parkinson's disease with LRRK2 variants", 'timeFrame': '10 years', 'description': "Establish the database of Parkinson's disease with LRRK2 variants in mainland China."}, {'measure': 'Clinical feature', 'timeFrame': '10 years', 'description': "Characterize the clinical feature in patients of Parkinson's disease with LRRK2 variants"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '25623333', 'type': 'RESULT', 'citation': "Guo JF, Li K, Yu RL, Sun QY, Wang L, Yao LY, Hu YC, Lv ZY, Luo LZ, Shen L, Jiang H, Yan XX, Pan Q, Xia K, Tang BS. Polygenic determinants of Parkinson's disease in a Chinese population. Neurobiol Aging. 2015 Apr;36(4):1765.e1-1765.e6. doi: 10.1016/j.neurobiolaging.2014.12.030. Epub 2015 Jan 6."}, {'pmid': '26234753', 'type': 'RESULT', 'citation': "Li K, Tang BS, Liu ZH, Kang JF, Zhang Y, Shen L, Li N, Yan XX, Xia K, Guo JF. LRRK2 A419V variant is a risk factor for Parkinson's disease in Asian population. Neurobiol Aging. 2015 Oct;36(10):2908.e11-5. doi: 10.1016/j.neurobiolaging.2015.07.012. Epub 2015 Jul 11."}, {'pmid': '21406209', 'type': 'RESULT', 'citation': "Yao LY, Guo JF, Wang L, Yu RH, Sun QY, Pan Q, Xia K, Tang BS, Shen L. LRRK2 Pro755Leu variant in ethnic Chinese population with Parkinson's disease. Neurosci Lett. 2011 May 9;495(1):35-8. doi: 10.1016/j.neulet.2011.03.030. Epub 2011 Mar 22."}, {'pmid': '19879329', 'type': 'RESULT', 'citation': "Wang L, Guo JF, Nie LL, Xu Q, Zuo X, Sun QY, Yan XX, Tang BS. A novel LRRK2 mutation in a mainland Chinese patient with familial Parkinson's disease. Neurosci Lett. 2010 Jan 14;468(3):198-201. doi: 10.1016/j.neulet.2009.10.080. Epub 2009 Oct 29."}, {'pmid': '29209554', 'type': 'RESULT', 'citation': "Zhang Y, Sun Q, Yi M, Zhou X, Guo J, Xu Q, Tang B, Yan X. Genetic Analysis of LRRK2 R1628P in Parkinson's Disease in Asian Populations. Parkinsons Dis. 2017;2017:8093124. doi: 10.1155/2017/8093124. Epub 2017 Oct 25."}]}, 'descriptionModule': {'briefSummary': "The purpose of the Chinese PD-LRRK2 Registry(CPD-LRRK2R) is to develop a database of patients of Parkinson's disease with leucine-rich repeat kinase 2 (LRRK2) gene variants in mainland China.", 'detailedDescription': "Parkinson's disease (PD) is the second most common disorder among neurodegenerative diseases. LRRK2 missense mutations are the most common known genetic cause of PD. However, some polymorphisms of LRRK2 such as G2385R and R1628P can also affect the risk of developing PD. The investigators aim to establish a database of PD with LRRK2 variants and characterize the clinical manifestation of these patients in mainland China.\n\nMethod:\n\n1. Peripheral blood from patients has been tested to have LRRK2 gene variants.\n2. Clinical manifestation will be measured by scales and neurological tests. Standard scales include: Unified Parkinson's Disease Rating Scale(UPDRS), Hoehn-Yahr stages, Non-Motor Symptoms Scale (NMSS), mini-mental state examination (MMSE), Parkinson disease sleep scales (PDSS), Rapid Eye Movement Sleep Behaviour Disorder Questionnaire(RBDQ-HK), Epworth Sleepiness Scale (ESS), Rome III functional constipation scale, the Scale for Outcomes in PD for Autonomic Symptoms (SCOPA-AUT), Parkinson Fatigue Scale (PFS), Cambridge-Hopkins Restless Legs Syndrome questionnaire (CHRLSq), Hyposmia rating scale(HRS), Hamilton depression scale, the 39-item Parkinson's Disease Questionnaire(PDQ-39), Freezing of gait scale(FOG), dyskinesia related scales, Wearing-off scale(WO).\n3. The investigators will also exam the blood biomarkers of PD such as uric acid and peripheral inflammatory markers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'PD patients with LRRK2 variants', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients diagnosed with PD by the United Kingdom Parkinson's Disease Society Brain Bank clinical diagnostic criteria or other standard criteria; PD patients detected with positive LRRK2 variants\n\nExclusion Criteria:\n\n\\-"}, 'identificationModule': {'nctId': 'NCT03523104', 'briefTitle': 'Chinese PD-LRRK2 Registry', 'organization': {'class': 'OTHER', 'fullName': 'Xiangya Hospital of Central South University'}, 'officialTitle': "The Chinese Parkinson's Disease With LRRK2 Variants Registry", 'orgStudyIdInfo': {'id': 'CPD-LRRK2R'}}, 'contactsLocationsModule': {'locations': [{'zip': '410008', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jifeng Guo, Ph.D.', 'role': 'CONTACT', 'email': 'guojifeng2003@163.com', 'phone': '+8613974936815'}, {'name': 'Qiying Sun, Ph.D.', 'role': 'CONTACT', 'email': 'sunqiying2015@163.com', 'phone': '+8615874907260'}], 'facility': 'Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Jifeng Guo, Ph.D.', 'role': 'CONTACT', 'email': 'guojifeng2003@163.com', 'phone': '+8613974936815'}, {'name': 'Beisha Tang, Ph.D.', 'role': 'CONTACT', 'email': 'bstang7398@163.com', 'phone': '+8613974856709'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiangya Hospital of Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}