Clinical trial NCT03848455: Multi-chip Meta-analysis of Parkinson's Disease for Clinical Validation of Small Samples of Key Genes in Disease
Official title: Multi-chip Meta-analysis of Parkinson's Disease for Clinical Validation of Small Samples of Key Genes in Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
synaptic correlation function
key gene
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From March 25, 2019 to April 25, 2019, patients with Parkinson's disease who were admitted to the Department of Neurology, Zhujiang Hospital, and healthy volunteers who recruited from population of community and students of the Southern Medical University.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Parkinson's Key Gene
timeFrame: 3 days
measure: Unified Parkinson's Disease Rating Scale 3.0（UPDRS 3.0）
timeFrame: 2 days
measure: Non-motor Symptom Scale (NMSS)
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospiatal
state: Guangdong
Study officials:
affiliation: Southern Medical University, China
name: Xiaoya Gao, doctor
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
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.
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.