A Registered Cohort Study on Brain Calcification | NCT04010201

Studies
A Registered Cohort Study on Brain Calcification

NCT04010201

Sponsor

Wan-Jin Chen

Status

Recruiting

Last Update Posted

Sep 23, 2019Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Brain Calcification

Interventions

Not provided

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

Sep 2019

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

Aug 25, 2019Actual

Primary Completion Date

Dec 31, 2029Estimated

Completion Date

Dec 31, 2079Estimated

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

Sep 19, 2019

Last Update Posted Date

Sep 23, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wan-Jin Chen, The Vice-Director for the Department of Neurology, First Affiliated Hospital of Fujian Medical UniversitySponsor-Investigator

Lead Sponsor

Wan-Jin ChenOTHER

Collaborators

Name	Class
Taipei Veterans General Hospital, Taiwan	OTHER_GOV
Chang Gung Memorial Hospital	OTHER

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

Brain calcification is a common neuroimaging feature in patients with metabolic, neurological, or developmental disorders, infectious diseases, traumatic or toxic history, as well as in otherwise normal older people. To understand the clinical and genetic characteristics of brain calcification, we establish a cohort of brain calcification to follow up patients with brain calcification.

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

2,000Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with brain calcium deposit(s) based on examinations of CT scans
Patients with total calcification score(TCS) greater than the physiological threshold
Relatives of brain calcification patients.
Unrelated healthy controls
Participants or Parent(s)/legal guardian(s) willing and able to complete the informed consent process

Exclusion Criteria:

Brain calcification caused by specific secondary factors such as infection, poisoning, and trauma
Participants declining or 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

Brain calcification patients who are diagnosed in the First Affiliated Hospital of Fujian Medical University

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yi Lin, PhD	Contact	86-0591-87982772		linyi7811@163.com
Wan-Jin Chen, PhD	Contact	86-0591-87982772		wanjinchen75@fjmu.edu.cn

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

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided