Parkinson DiseaseNCT03508960
Chinese EOPD Registry
An observational study of Parkinson Disease, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 50 years
- Conditions the study is for
- Parkinson Disease
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2017to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: PD patients with early-onset
Who may be able to join
- Patients diagnosed with PD by UKBB and other standard criteria Age of onset is no more than 50 years old.
Who cannot join
- Patients have a family history of PD.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Jifeng Guo, Ph.D., +8613974936815, guojifeng2003@163.com
Qiying Sun, Ph.D., +8615874907260, sunqiying2015@163.com
About this study
Official title: The Chinese Early-onset Parkinson's Disease Registry
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.
Read the detailed description
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.
Method:
- 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)
- Peripheral blood from patients was collected for whole exome sequencing.
- The environmental factors are explored by questionnaires including smoking,drinking, pesticide and heavy metals.
- Conditions
- Parkinson Disease
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Database of Early-onset Parkinson's Disease
To collect 3000 patients with early-onset parkinson's disease and establish the database of early-onset Parkinson's disease in mainland China.
Measured: 10 years
Risk Factors
To characterize clinical feature and environmental factors among Chinese early-onset parkinson's disease
Measured: 10 years
Genetic Basis
To characterize the genetic basis of Chinese EOPD and detect clinically relevant genetic variants in these cases.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start1 Feb 2017
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508960
- Sponsor's protocol ID
- CEOPDR
- Status last verified
- Apr 2018
- First submitted
- 11 Apr 2018
- Last updated
- 11 May 2018
- Results posted
- No
Publications
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.
PubMed 26295349Liu 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.
PubMed 25528405Li 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.
PubMed 26234753Liu 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.
PubMed 27036214Fan 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.
PubMed 27085534
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Chinese Early-onset Parkinson's Disease Registry
- ClinicalTrials.gov ID
- NCT03508960
- Acronym / sponsor ID
- CEOPDR
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 26 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Method:
- 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)
- Peripheral blood from patients was collected for whole exome sequencing.
- The environmental factors are explored by questionnaires including smoking,drinking, pesticide and heavy metals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- PD patients with early-onset
Key inclusion criteria (1 listed)
- Patients diagnosed with PD by UKBB and other standard criteria Age of onset is no more than 50 years old.
Key exclusion criteria (1 listed)
- Patients have a family history of PD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Database of Early-onset Parkinson's Disease
Time frame: 10 years
To collect 3000 patients with early-onset parkinson's disease and establish the database of early-onset Parkinson's disease in mainland China.
Risk Factors
Time frame: 10 years
To characterize clinical feature and environmental factors among Chinese early-onset parkinson's disease
Genetic Basis
Time frame: 10 years
To characterize the genetic basis of Chinese EOPD and detect clinically relevant genetic variants in these cases.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Background: PubMed 26295349Yang 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.
- Background: PubMed 25528405Liu 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.
- Background: PubMed 26234753Li 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.
- Results publication: PubMed 27036214Liu 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.
- Results publication: PubMed 27085534Fan 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.
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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.
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 Disease, run by Xiangya Hospital of Central South University 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 11 May 2018. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact J Guo, Ph.D. (+8613974936815, guojifeng2003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Database of Early-onset Parkinson's Disease (time frame: 10 years). 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 NCT03508960, which also lists 5 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 11 May 2018.