Multi-chip Meta-analysis of Parkinson's Disease for Clinical Validation of Small Samples of Key Genes in Disease

Parkinson's Disease Clinical Trial

Official title:

Multi-chip Meta-analysis of Parkinson's Disease for Clinical Validation of Small Samples of Key Genes in Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03848455
• Other study ID #: 2018-SJNK-008-1
• Status: Completed
• Start date: February 25, 2019
• Est. completion date: February 20, 2021

Study information

• Verified date: July 2023
• Source: Zhujiang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The research team used meta-analytical statistical methods to integrate the results of different research groups on Parkinson's disease, using meta-analysis to find key genes related to the pathogenesis and development of Parkinson's disease, and to make small clinical results. The verification of the sample, the internal mechanism of the pathogenesis of Parkinson's disease and provide guidance and reference for subsequent experimental research.

Description:

Parkinson's disease (PD) is a relatively common degenerative disease of the central nervous system. As society gradually becomes aging, the number of PD patients is increasing, but its exact pathogenesis is still not fully understood. May be related to genetic factors, environmental factors, immunological abnormalities, mitochondrial dysfunction and oxidative stress, ageing, apoptosis and other factors; the current genetic diagnosis is in the ascendant, making the understanding of the etiology and pathogenesis of Parkinson's disease more In-depth, provide more basis and means for the pathogenesis and development of Parkinson's disease, but due to the number of individual samples, operational norms and platform differences, different research groups have great differences in the results of gene chip research on Parkinson's mechanism, resulting in the reliability is poor; In order to improve the credibility of the pathogenesis of Parkinson's disease and the development of genetic diagnosis, the investigators use the statistical means of meta-analysis to integrate the results of the chip research on Parkinson's disease in different research groups and find synaptic correlation function may be closely related to the development of Parkinson's disease, PPP2CA, PPP3CB, SYNJ1, NSF, CYCS genes may be key genes in the pathogenesis of Parkinson's disease, and the expression of these genes is related to the pathogenesis and development of PD patients. the investigators will conduct a small sample validation in the clinic to explore the intrinsic mechanism of Parkinson's disease and follow-up experimental research provides guidance and reference.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: February 20, 2021
• Est. primary completion date: February 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• PD group:
• Patients who meet the 2016 China Parkinson's diagnostic criteria and the 2015 International Parkinson's and Movement Disorders Association (MDS) Parkinson's disease diagnostic criteria
• Newly diagnosed primary PD patients, diagnosed within 3-6 months
• Informed consent to the study
• Age > 18 older
• Non-PD group:
• Age, gender-matched PD group
• Non-PD, non-PDS, non-neurological degenerative disease, patients without inflammatory disease and related family history
• Informed consent to the study
• Age > 18 older

Exclusion Criteria:

• Severe craniocerebral trauma patients
• Disturbance of consciousness
• Severe organic diseases, cerebral hemorrhage, cerebral thrombosis, severe coronary heart disease and lung disease, severe liver and kidney dysfunction, severe diabetes, severe hearing And visual impairment
• History of severe brain tumors, encephalitis or brain surgery

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Diagnostic Test:
• genetic diagnosis
The venous blood of the two groups of patients was taken for genetic testing, and the expression levels of PPP2CA, PPP3CB, SYNJ1, NSF and CYCS were extracted by pre-processing the genetic data of PD and non-PD patients.

Locations

Country	Name	City	State
China	Zhujiang Hospiatal	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

Lee Y, Kim MS, Lee J. Neuroprotective strategies to prevent and treat Parkinson's disease based on its pathophysiological mechanism. Arch Pharm Res. 2017 Oct;40(10):1117-1128. doi: 10.1007/s12272-017-0960-8. Epub 2017 Sep 26. — View Citation

Li X, Zhang Y, Wang Y, Xu J, Xin P, Meng Y, Wang Q, Kuang H. The Mechanisms of Traditional Chinese Medicine Underlying the Prevention and Treatment of Parkinson's Disease. Front Pharmacol. 2017 Sep 19;8:634. doi: 10.3389/fphar.2017.00634. eCollection 2017. — View Citation

Lotankar S, Prabhavalkar KS, Bhatt LK. Biomarkers for Parkinson's Disease: Recent Advancement. Neurosci Bull. 2017 Oct;33(5):585-597. doi: 10.1007/s12264-017-0183-5. Epub 2017 Sep 21. — View Citation

Tseng GC, Ghosh D, Feingold E. Comprehensive literature review and statistical considerations for microarray meta-analysis. Nucleic Acids Res. 2012 May;40(9):3785-99. doi: 10.1093/nar/gkr1265. Epub 2012 Jan 19. — View Citation

Walsh CJ, Hu P, Batt J, Santos CC. Microarray Meta-Analysis and Cross-Platform Normalization: Integrative Genomics for Robust Biomarker Discovery. Microarrays (Basel). 2015 Aug 21;4(3):389-406. doi: 10.3390/microarrays4030389. — View Citation

Wang X, Kang DD, Shen K, Song C, Lu S, Chang LC, Liao SG, Huo Z, Tang S, Ding Y, Kaminski N, Sibille E, Lin Y, Li J, Tseng GC. An R package suite for microarray meta-analysis in quality control, differentially expressed gene analysis and pathway enrichment detection. Bioinformatics. 2012 Oct 1;28(19):2534-6. doi: 10.1093/bioinformatics/bts485. Epub 2012 Aug 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parkinson's Key Gene	The blood of patients were taken for genetic testing and relative expression levels of the genes(These genes expression relative to a house keeping gene:GAPDH) for PPP2CA, PPP3CB, SYNJ1, NSF were extracted.The method we used is RT-PCR.	3 days
Primary	Unified Parkinson's Disease Rating Scale 3.0(UPDRS 3.0)	The total score ranges from 0 to 199( minimum score is 0 and maximum scores is 199), in which a lower score denotes a better perception of the patient's.; Scoring the mental, behavioral and emotional, daily living activities, exercise tests, and drug treatment complications associated with UPDRS3.0 in patients with Parkinson's disease;each item 0-4 points, total score 199 points, 0-50 points: limb and body mild dysfunction, posture response normal;51-100 points: mild postural reaction disorder, self-care in daily life, loss of labor force;101-199: obvious postural reaction disorder, loss of daily life and labor force, may need help to get up and confined to wheelchair life;The more severe the symptoms of Parkinson's disease, the higher the score.	2 days
Primary	Non-motor Symptom Scale (NMSS)	Scoring based on the patient's own situation in the last month Severity: 1 = mild; 2 = moderate; 3 = severe Frequency: 1 = very little (less than once a week); 2 = often (1 time a week); 3 = frequent (a few times a week); 4 = very frequent (every day or persist)	2 days