- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03508986
Chinese FPD Registry
May 3, 2018 updated by: Xiangya Hospital of Central South University
The Chinese Familial Parkinson's Disease Registry
The purpose of the Chinese Familial Parkinson's disease Registry (CFPDR) is to develop a database of patients with familial Parkinson's disease (PD) in China.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Parkinson's disease (PD) is the second most common disorder among degenerative neurological disease. Familial PD (FPD) has its unique clinical feature and genetic basis. We aim to establish a database of FPD,and characterize the clinical feature, genetic basis, environmental factors and their interactions FPD 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 and other members in family will be collected for familial PD genetic testing.
- The environmental factors are exploded by questionnaires including smoking,drinking, pesticide and heavy metals.
Study Type
Observational
Enrollment (Anticipated)
1500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410008
- Recruiting
- Xiangya Hospital of Central South University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients in hospitals or community
Description
Inclusion Criteria:
- Clinical diagnosis of Parkinson's disease, and either family history of Parkinson's disease (first or second degree family member affected by Parkinson's disease) AND/OR Clinical diagnosis of Parkinson's disease and their parents are close relatives(First or second degree family member of an Index Case, affected or unaffected by Parkinson's disease).
Exclusion Criteria:
- Lack of capacity to consent to participate in the project
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Database of Familial Parkinson's disease
Time Frame: 10 years
|
To collect 1500 patients with familial Parkinson's disease and establish the database of Familial Parkinson's disease (FPD) in mainland China.
|
10 years
|
|
Risk Factors
Time Frame: 10 years
|
To characterize clinical feature and environmental factors among Chinese familial parkinson's disease
|
10 years
|
|
Genetic Basis
Time Frame: 10 years
|
To characterize the genetic basis of Chinese FPD and detect clinically relevant genetic variants in these cases
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Yan W, Tang B, Zhou X, Lei L, Li K, Sun Q, Xu Q, Yan X, Guo J, Liu Z. TMEM230 mutation analysis in Parkinson's disease in a Chinese population. Neurobiol Aging. 2017 Jan;49:219.e1-219.e3. doi: 10.1016/j.neurobiolaging.2016.10.007. Epub 2016 Oct 11.
- 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.
- Li 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.
- Liu Z, Guo J, Li K, Qin L, Kang J, Shu L, Zhang Y, Wei Y, Yang N, Luo Y, Sun Q, Xu Q, Yan X, Tang B. Mutation analysis of CHCHD2 gene in Chinese familial Parkinson's disease. Neurobiol Aging. 2015 Nov;36(11):3117.e7-3117.e8. doi: 10.1016/j.neurobiolaging.2015.08.010. Epub 2015 Aug 15.
- Guo JF, Li K, Yu RL, Sun QY, Wang L, Yao LY, Hu YC, Lv ZY, Luo LZ, Shen L, Jiang H, Yan XX, Pan Q, Xia K, Tang BS. Polygenic determinants of Parkinson's disease in a Chinese population. Neurobiol Aging. 2015 Apr;36(4):1765.e1-1765.e6. doi: 10.1016/j.neurobiolaging.2014.12.030. Epub 2015 Jan 6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 1, 2017
Primary Completion (ANTICIPATED)
February 1, 2027
Study Completion (ANTICIPATED)
February 1, 2027
Study Registration Dates
First Submitted
April 11, 2018
First Submitted That Met QC Criteria
April 24, 2018
First Posted (ACTUAL)
April 26, 2018
Study Record Updates
Last Update Posted (ACTUAL)
May 11, 2018
Last Update Submitted That Met QC Criteria
May 3, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CFPDR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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