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A Registered Cohort Study on Brain Calcification

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010201
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : September 23, 2019
Sponsor:
Collaborators:
Taipei Veterans General Hospital, Taiwan
Chang Gung Memorial Hospital
Information provided by (Responsible Party):
Wan-Jin Chen, First Affiliated Hospital of Fujian Medical University

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.

Condition or disease
Brain Calcification

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Registered Cohort Study on Brain Calcification
Actual Study Start Date : August 25, 2019
Estimated Primary Completion Date : December 31, 2029
Estimated Study Completion Date : December 31, 2079

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals




Primary Outcome Measures :
  1. The incidence of hereditary brain calcification [ Time Frame: Up to 20 years ]
    Look for the causative gene in the patient with brian calcification



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Brain calcification patients who are diagnosed in the First Affiliated Hospital of Fujian Medical University
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010201


Contacts
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Contact: Yi Lin, PhD 86-0591-87982772 linyi7811@163.com
Contact: Wan-Jin Chen, PhD 86-0591-87982772 wanjinchen75@fjmu.edu.cn

Locations
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China, Fujian
Department of Neurology, First Affiliated Hospital Fujian Medical University Recruiting
Fuzhou, Fujian, China, 350005
Contact: Wan-Jin Chen, PhD    86-0591-87982772 ext +13860601359    wanjinchen75@fjmu.edu.cn   
Principal Investigator: Wan-Jin Chen, MD,PhD         
Sub-Investigator: Ning Wang, MD, PhD         
Sponsors and Collaborators
Wan-Jin Chen
Taipei Veterans General Hospital, Taiwan
Chang Gung Memorial Hospital
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Responsible Party: Wan-Jin Chen, The Vice-Director for the Department of Neurology, First Affiliated Hospital of Fujian Medical University
ClinicalTrials.gov Identifier: NCT04010201    
Other Study ID Numbers: MRCTA,ECFAH of FMU [2019]198
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wan-Jin Chen, First Affiliated Hospital of Fujian Medical University:
brain calcification
natural history
genetics
Additional relevant MeSH terms:
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Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases