Brain CalcificationNCT04010201
A Registered Cohort Study on Brain Calcification
An observational study of Brain Calcification, run by Wan-Jin Chen at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Brain Calcification
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2019to 31 Dec 2079
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Brain calcification patients who are diagnosed in the First Affiliated Hospital of Fujian Medical University
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Neurology, First Affiliated Hospital Fujian Medical University
Fuzhou, Fujian, 350005
Wan-Jin Chen, PhD, 86-0591-87982772 ext. +13860601359, wanjinchen75@fjmu.edu.cn
Wan-Jin Chen, MD,PhD
About this study
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.
- Conditions
- Brain Calcification
- Keywords
- brain calcification, natural history, genetics
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of hereditary brain calcification
Look for the causative gene in the patient with brian calcification
Measured: Up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start25 Aug 2019
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2079 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain CalcificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wan-Jin Chen
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan, Chang Gung Memorial Hospital
- Responsible party
- Sponsor-investigator, Wan-Jin Chen, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010201
- Sponsor's protocol ID
- MRCTA,ECFAH of FMU [2019]198
- Status last verified
- Sep 2019
- First submitted
- 4 Jul 2019
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registered Cohort Study on Brain Calcification
- ClinicalTrials.gov ID
- NCT04010201
- Acronym / sponsor ID
- MRCTA,ECFAH of FMU [2019]198
- Conditions
- Brain Calcification
- Keywords
- brain calcification, natural history, genetics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Wan-Jin ChenUniversity, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan, Chang Gung Memorial Hospital
- Study start
- 25 Aug 2019 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2079 (estimated)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Brain calcification patients who are diagnosed in the First Affiliated Hospital of Fujian Medical University
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence of hereditary brain calcification
Time frame: Up to 20 years
Look for the causative gene in the patient with brian calcification
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Calcification, run by Wan-Jin Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Lin, PhD (86-0591-87982772, linyi7811@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of hereditary brain calcification (time frame: Up to 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019; AzTrials last refreshed its copy on 30 Oct 2026.