A Registered Cohort Study on Cerebellar Ataxia in the Org... | NCT04010214

Studies
A Registered Cohort Study on Cerebellar Ataxia in the Organization in South-East China for Cerebellar Ataxia Research (OSCCAR)

NCT04010214

Sponsor

Ning Wang, MD., PhD.

Status

Recruiting

Last Update Posted

Jul 12, 2023Actual

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Cerebellar Ataxia

Interventions

No intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2019Actual

Primary Completion Date

Dec 2039Estimated

Completion Date

Dec 2059Estimated

First Submitted Date

Jul 4, 2019

First Submission Date that Met QC Criteria

Jul 4, 2019

First Posted Date

Jul 8, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2023

Last Update Posted Date

Jul 12, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ning Wang, MD., PhD., The Vice President, First Affiliated Hospital of Fujian Medical UniversitySponsor-Investigator

Lead Sponsor

Ning Wang, MD., PhD.OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Estimated

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence of hereditary cerebellar ataxia	Look for the causative gene in the patient with cerebellar ataxia	Up to 20years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with cerebellar ataxia who are diagnosed by tow neurologists in the Organization in South-East China for Cerebellar Ataxia Research (OSCCAR) from the First Affiliated Hospital of Fujian Medical University.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shi-Rui Gan, MD.Phd	Contact	+8613850172725		ganshirui@fjmu.edu.cn
Yi Lin, MD.Phd	Contact	+8613615039153		linyi7811@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurology ,First Affiliated Hospital Fujian Medical University	Recruiting	Fuzhou	Fujian	350005	China

Condition Browse Module

MeSH Terms

ID	Term
D002524	Cerebellar Ataxia

Ancestor Terms

ID	Term
D002526	Cerebellar Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided