NCT03848455

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
238

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

February 25, 2019

Completed
11 months until next milestone

Results Posted

Study results publicly available

January 18, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2021

Completed
Last Updated

July 28, 2023

Status Verified

July 1, 2023

Enrollment Period

2 years

First QC Date

February 19, 2019

Results QC Date

November 12, 2019

Last Update Submit

July 20, 2023

Conditions

Keywords

Parkinson's diseasesynaptic correlation functionkey gene

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Parkinson's disease group

1. 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; 2. Newly diagnosed primary PD patients, diagnosed within 3-6 months; 3. informed consent to the study; 4. age \> 18 older.

Diagnostic Test: genetic diagnosis

Non-parkinson group

Non-parkinson group inclusion criteria: 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.

Diagnostic Test: genetic diagnosis

Interventions

genetic diagnosisDIAGNOSTIC_TEST

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.

Non-parkinson groupParkinson's disease group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhujiang Hospiatal

Guangzhou, Guangdong, 510000, China

Location

Related Publications (6)

  • 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.

    PMID: 28970800BACKGROUND
  • 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.

    PMID: 28952032BACKGROUND
  • 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.

    PMID: 28936761BACKGROUND
  • 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.

    PMID: 27600230BACKGROUND
  • 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.

    PMID: 22262733BACKGROUND
  • 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.

    PMID: 22863766BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

After admission, 2 tubes of venous blood (8ml) were extracted from PD group and control group respectively for genetic testing

MeSH Terms

Conditions

Parkinson Disease

Interventions

Preimplantation Diagnosis

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and GynecologicalDiagnostic Techniques and ProceduresDiagnosis

Results Point of Contact

Title
Xiaoya Gao
Organization
Zhujiang Hospital of Southern Medical University

Study Officials

  • Xiaoya Gao, doctor

    Southern Medical University, China

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chief Physician

Study Record Dates

First Submitted

February 19, 2019

First Posted

February 20, 2019

Study Start

February 25, 2019

Primary Completion

February 20, 2021

Study Completion

February 20, 2021

Last Updated

July 28, 2023

Results First Posted

January 18, 2020

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations