Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 7:13 PM
Study NCT ID:
NCT03508960
Status:
RECRUITING
Last Update Posted:
2018-05-11
First Post:
2018-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chinese EOPD 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': 3000}, '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': '2018-05-03', 'studyFirstSubmitDate': '2018-04-11', 'studyFirstSubmitQcDate': '2018-04-24', 'lastUpdatePostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Database of Early-onset Parkinson's Disease", 'timeFrame': '10 years', 'description': "To collect 3000 patients with early-onset parkinson's disease and establish the database of early-onset Parkinson's disease in mainland China."}, {'measure': 'Risk Factors', 'timeFrame': '10 years', 'description': "To characterize clinical feature and environmental factors among Chinese early-onset parkinson's disease"}, {'measure': 'Genetic Basis', 'timeFrame': '10 years', 'description': 'To characterize the genetic basis of Chinese EOPD and detect clinically relevant genetic variants in these cases.'}]}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '26295349', 'type': 'BACKGROUND', 'citation': 'Yang Y, Tang BS, Weng L, Li N, Shen L, Wang J, Zuo CT, Yan XX, Xia K, Guo JF. Genetic Identification Is Critical for the Diagnosis of Parkinsonism: A Chinese Pedigree with Early Onset of Parkinsonism. PLoS One. 2015 Aug 21;10(8):e0136245. doi: 10.1371/journal.pone.0136245. eCollection 2015.'}, {'pmid': '25528405', 'type': 'BACKGROUND', 'citation': "Liu ZH, Guo JF, Li K, Wang YQ, Kang JF, Wei Y, Sun QY, Xu Q, Wang DL, Xia K, Yan XX, Xu CS, Tang BS. Analysis of several loci from genome-wide association studies in Parkinson's disease in mainland China. Neurosci Lett. 2015 Feb 5;587:68-71. doi: 10.1016/j.neulet.2014.12.027. Epub 2014 Dec 17."}, {'pmid': '26234753', 'type': 'BACKGROUND', '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': '27036214', 'type': 'RESULT', 'citation': "Liu Z, Tang B, Guo J, Zhou X, Sun Q, Xu Q, Xu C, Yan X. Mutations analysis of RAB39B gene in Chinese early-onset Parkinson's disease. Parkinsonism Relat Disord. 2016 Jul;28:157-8. doi: 10.1016/j.parkreldis.2016.03.019. Epub 2016 Mar 24. No abstract available."}, {'pmid': '27085534', 'type': 'RESULT', 'citation': 'Fan K, Tang BS, Wang YQ, Kang JF, Li K, Liu ZH, Sun QY, Xu Q, Yan XX, Guo JF. The GBA, DYRK1A and MS4A6A polymorphisms influence the age at onset of Chinese Parkinson patients. Neurosci Lett. 2016 May 16;621:133-136. doi: 10.1016/j.neulet.2016.04.014. Epub 2016 Apr 13.'}]}, 'descriptionModule': {'briefSummary': "The purpose of the Chinese Early-onst Parkinson's disease Registry (CEOPDR) is to develop a database of persons with early-onset Parkinson's disease (EOPD) in China.", 'detailedDescription': "Parkinson's disease (PD) is the second most common disorder among degenerative neurological disease. Early-onset PD (EOPD) has its unique clinical feature and genetic basis.Investigators aim to establish a database of EOPD,and characterize the clinical feature, genetic basis, environmental factors and their interactions EOPD in China.\n\nMethod:\n\n1. Clinical feature will be measured by scales and neurological tests.Standard scales includes: Unified Parkinson's Disease Rating Scale(UPDRS), Hoehn-Yahr stages, NMSS, MMSE, PDSS(Parkinson disease sleep scales),Rapid Eye Movement Sleep Behaviour Disorder Questionnaire(RBDQ-HK),ESS(Epworth Sleepiness Scale),Rome III functional constipation scale，SCOPA-AUT (the Scale for Outcomes in PD for Autonomic Symptoms)，PFS(Parkinson Fatigue Scale)，CH-RLSq，Hyposmia rating scale(HRS)HAMILT depression scale，the 39-item Parkinson's Disease Questionnaire(PDQ-39)，Freezing of gait scale(FOG)，dyskinesia related scales, Wearing-off scale(WO)\n2. Peripheral blood from patients was collected for whole exome sequencing.\n3. The environmental factors are explored by questionnaires including smoking,drinking, pesticide and heavy metals."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'PD patients with early-onset', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with PD by UKBB and other standard criteria Age of onset is no more than 50 years old.\n\nExclusion Criteria:\n\n* Patients have a family history of PD.'}, 'identificationModule': {'nctId': 'NCT03508960', 'briefTitle': 'Chinese EOPD Registry', 'organization': {'class': 'OTHER', 'fullName': 'Xiangya Hospital of Central South University'}, 'officialTitle': "The Chinese Early-onset Parkinson's Disease Registry", 'orgStudyIdInfo': {'id': 'CEOPDR'}}, 'contactsLocationsModule': {'locations': [{'zip': '410000', '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': 'J 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'}}}}