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出境医 / 临床实验 / A Registered Cohort Study on Cerebellar Ataxia

A Registered Cohort Study on Cerebellar Ataxia

Study Description
Brief Summary:
Cerebellar ataxia is a form of ataxia originating in the cerebellum. Cerebellar ataxia can occur as a result of many diseases and may present with symptoms of an inability to coordinate balance, gait, extremity and eye movements. To understand the clinical and genetic characteristics of cerebellar ataxia, we establish a registered cohort to follow up Chinese patients with cerebellar ataxia.

Condition or disease Intervention/treatment
Cerebellar Ataxia Other: No intervention

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Registered Cohort Study on Cerebellar Ataxia
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 2039
Estimated Study Completion Date : December 2059
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. The incidence of hereditary cerebellar ataxia [ Time Frame: Up to 20years ]
    Look for the causative gene in the patient with cerebellar ataxia


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date July 4, 2019
First Posted Date July 8, 2019
Last Update Posted Date November 13, 2020
Actual Study Start Date July 1, 2019
Estimated Primary Completion Date December 2039   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 4, 2019)
The incidence of hereditary cerebellar ataxia [ Time Frame: Up to 20years ]
Look for the causative gene in the patient with cerebellar ataxia
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Registered Cohort Study on Cerebellar Ataxia
Official Title A Registered Cohort Study on Cerebellar Ataxia
Brief Summary Cerebellar ataxia is a form of ataxia originating in the cerebellum. Cerebellar ataxia can occur as a result of many diseases and may present with symptoms of an inability to coordinate balance, gait, extremity and eye movements. To understand the clinical and genetic characteristics of cerebellar ataxia, we establish a registered cohort to follow up Chinese patients with cerebellar ataxia.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with cerebellar ataxia who are diagnosed in the First Affiliated Hospital of Fujian Medical University by tow neurologists.
Condition Cerebellar Ataxia
Intervention Other: No intervention
No intervention
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 4, 2019)
1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2059
Estimated Primary Completion Date December 2039   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with cerebellar ataxia based on the diagnoses of tow neurologists
  • Relatives of patients with cerebellar ataxia
  • Unrelated healthy controls
  • Participants or legal guardian(s) willing and able to complete the informed consent process

Exclusion Criteria:

  • Participants are unable to comply with trial procedures and visit schedule
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts
Contact: Shi-Rui Gan, MD.Phd +8613850172725 ganshirui@fjmu.edu.cn
Contact: Yi Lin, MD.Phd +8613615039153 linyi7811@163.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04010214
Other Study ID Numbers MRCTA,ECFAH of FMU[2019]195
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Ning Wang, MD., PhD., First Affiliated Hospital of Fujian Medical University
Study Sponsor Ning Wang, MD., PhD.
Collaborators Not Provided
Investigators Not Provided
PRS Account First Affiliated Hospital of Fujian Medical University
Verification Date November 2020