Parkinson's DiseaseNCT03848455

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

An observational study of Parkinson's Disease, run by Zhujiang Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Parkinson's Disease
What is being tested?: genetic diagnosis
How many people: 238 participants
Where: 1 siteChina
Study dates: 25 Feb 2019to 20 Feb 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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.

Who may be able to join

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:

Show all 10Show fewer

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

Zhujiang Hospiatal
Guangzhou, Guangdong, 510000

Other trials in China

About this study

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.

Read the 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.

Conditions: Parkinson's Disease
Being tested: genetic diagnosis
Keywords: Parkinson's disease, synaptic correlation function, key gene
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT03848455
Study group	Role	What they receive
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. Receives: 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. Receives: Diagnostic Test: genetic diagnosis

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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)
Measured: 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Feb 201920 Feb 2021

First posted20 Feb 2019
Study start25 Feb 2019
Primary completion20 Feb 2021
Study completion20 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
More trials run by Zhujiang HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Retrospective
Enrolment: 238 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03848455
Sponsor's protocol ID: 2018-SJNK-008-1
Status last verified: Jul 2023
First submitted: 19 Feb 2019
Last updated: 28 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 28970800
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.
PubMed 28952032
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.
PubMed 28936761
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.
PubMed 27600230
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.
PubMed 22262733
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.
PubMed 22863766

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-chip Meta-analysis of Parkinson's Disease for Clinical Validation of Small Samples of Key Genes in Disease
ClinicalTrials.gov ID: NCT03848455
Acronym / sponsor ID: 2018-SJNK-008-1
Conditions: Parkinson's Disease
Keywords: Parkinson's disease, synaptic correlation function, key gene
Study type: Observational
Recruitment status: Completed
Enrolment: 238 participants (actual)
Lead sponsor: Zhujiang HospitalUniversity, hospital or other
Study start: 25 Feb 2019 (actual)
Primary completion: 20 Feb 2021 (actual)
Study completion: 20 Feb 2021 (actual)
First posted: 20 Feb 2019 (actual)
Results: Posted 18 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Parkinson's disease group	–	Diagnostic Test: genetic diagnosis1. 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.
Non-parkinson group	–	Diagnostic Test: genetic diagnosisNon-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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (10 listed)

PD group：
Non-PD group:

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
genetic diagnosisThe 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.	Diagnostic test	Non-parkinson group, Parkinson's disease group

Primary outcome

Parkinson's Key Gene
Time frame: 3 days
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.
Unified Parkinson's Disease Rating Scale 3.0（UPDRS 3.0）
Time frame: 2 days
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.
Non-motor Symptom Scale (NMSS)
Time frame: 2 days
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)

Results and safety

Results posted to the registry on 18 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Controls	125	125
Parkinson's Disease Group	90	90
Parkinson-plus Syndrome Group	23	23

Primary outcome: Parkinson's Key Gene

Time frame: 3 days. Median (Inter-Quartile Range). Unit: gene expression relative to GAPDH

Measure	Parkinson's Disease Group n = 90	Healthy Controls n = 125	Parkinson-plus Syndrome Group n = 23
PPP2CA	1.502 (0.718 to 3.110)	3.653 (1.990 to 5.856)	0.916 (0.654 to 1.452)
PPP3CB	1.669 (0.792 to 2.947)	2.237 (0.903 to 4.416)	2.320 (1.110 to 3.269)
SYNJ1	0.924 (0.537 to 1.585)	4.662 (2.278 to 7.452)	5.206 (2.541 to 6.150)
NSF	1.002 (0.513 to 2.150)	3.058 (1.665 to 4.909)	1.408 (0.864 to 2.689)

Parkinson's Disease Group vs Healthy Controls vs Parkinson-plus Syndrome Group: p <0.001, Kruskal-Wallis
Parkinson's Disease Group vs Healthy Controls vs Parkinson-plus Syndrome Group: p <0.001, Kruskal-Wallis
Parkinson's Disease Group vs Healthy Controls vs Parkinson-plus Syndrome Group: p = 0.149, Kruskal-Wallis

Primary outcome: Unified Parkinson's Disease Rating Scale 3.0（UPDRS 3.0）

Time frame: 2 days. Mean (Standard Deviation). Unit: score on a scale

Measure	Parkinson's Disease Group n = 90	Healthy Controls n = 0	Parkinson-plus Syndrome Group n = 0
Value	61.352 (29.611)	–	–

Population analysed: The "Unified Parkinson's Disease Rating Scale 3.0" is just suitable for PD patients,so there are no relative result for the group of healthy controls and Parkinson-plus syndrome group.

Primary outcome: Non-motor Symptom Scale (NMSS)

Time frame: 2 days

Population analysed: Data were not collected.

Adverse events

Time frame: 1 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Parkinson's Disease Group	0 of 90 (0%)	0 of 90 (0%)	0 of 90
Healthy Controls	0 of 125 (0%)	0 of 125 (0%)	0 of 125
Parkinson-plus Syndrome Group	0 of 23 (0%)	0 of 23 (0%)	0 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28970800Li 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.
Background: PubMed 28952032Lee 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.
Background: PubMed 28936761Lotankar 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.
Background: PubMed 27600230Walsh 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.
Background: PubMed 22262733Tseng 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.
Background: PubMed 22863766Wang 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.
Individual participant dataSharing planned: No

Related trials for Parkinson's Disease

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xiaoya Gao, doctor principal investigator

Southern Medical University, China

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson's Disease, run by Zhujiang Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parkinson's Key Gene (time frame: 3 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03848455, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.