- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04010201
A Registered Cohort Study on Brain Calcification
September 19, 2019 updated by: Wan-Jin Chen
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
2000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yi Lin, PhD
- Phone Number: 86-0591-87982772
- Email: linyi7811@163.com
Study Contact Backup
- Name: Wan-Jin Chen, PhD
- Phone Number: 86-0591-87982772
- Email: wanjinchen75@fjmu.edu.cn
Study Locations
-
-
Fujian
-
Fuzhou, Fujian, China, 350005
- Recruiting
- Department of Neurology, First Affiliated Hospital Fujian Medical University
-
Principal Investigator:
- Wan-Jin Chen, MD,PhD
-
Sub-Investigator:
- Ning Wang, MD, PhD
-
Contact:
- Wan-Jin Chen, PhD
- Phone Number: +13860601359 86-0591-87982772
- Email: wanjinchen75@fjmu.edu.cn
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Brain calcification patients who are diagnosed in the First Affiliated Hospital of Fujian Medical University
Description
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
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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of hereditary brain calcification
Time Frame: Up to 20 years
|
Look for the causative gene in the patient with brian calcification
|
Up to 20 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
August 25, 2019
Primary Completion (Anticipated)
December 31, 2029
Study Completion (Anticipated)
December 31, 2079
Study Registration Dates
First Submitted
July 4, 2019
First Submitted That Met QC Criteria
July 4, 2019
First Posted (Actual)
July 8, 2019
Study Record Updates
Last Update Posted (Actual)
September 23, 2019
Last Update Submitted That Met QC Criteria
September 19, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRCTA,ECFAH of FMU [2019]198
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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