NCT04010201

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
653mo left

Started Aug 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Aug 2019Dec 2079

First Submitted

Initial submission to the registry

July 4, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

August 25, 2019

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
50 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2079

Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

10.4 years

First QC Date

July 4, 2019

Last Update Submit

September 19, 2019

Conditions

Brain Calcification

Keywords

brain calcificationnatural historygenetics

Outcome Measures

Primary Outcomes (1)

  • The incidence of hereditary brain calcification

    Look for the causative gene in the patient with brian calcification

    Up to 20 years

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, First Affiliated Hospital Fujian Medical University

Fuzhou, Fujian, 350005, China

RECRUITING

Central Study Contacts

Yi Lin, PhD

CONTACT

86-0591-87982772linyi7811@163.com

Wan-Jin Chen, PhD

CONTACT

86-0591-87982772wanjinchen75@fjmu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
The Vice-Director for the Department of Neurology

Study Record Dates

First Submitted

July 4, 2019

First Posted

July 8, 2019

Study Start

August 25, 2019

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2079

Last Updated

September 23, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)