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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ChiCTR
Last refreshed on: 27 May 2019
Main ID:  ChiCTR1900023410
Date of registration: 2019-05-26
Prospective Registration: Yes
Primary sponsor: Shanghai Tongren Hospital
Public title: The application of quantitative susceptibility mapping and blood and urine cell culture in Wilson's disease
Scientific title: The application of quantitative susceptibility mapping and blood and urine cell culture in Wilson's disease
Date of first enrolment: 2019-06-01
Target sample size: Target condition:40;Difficult condition:20
Recruitment status: Recruiting
URL:  http://www.chictr.org.cn/showproj.aspx?proj=39437
Study type:  Diagnostic test
Study design:  Factorial  
Phase:  0
Countries of recruitment
China
Contacts
Name: Xiaoping Wang   
Address:  1111 Xianxia Road, Changning District, Shanghai
Telephone: +86 13311986373
Email: wangxp@ustc.edu
Affiliation:  Shanghai Tongren Hospital
Name: Xiangzhen Yuan   
Address:  1111 Xianxia Road, Changning District, Shanghai
Telephone: +86 19916546114
Email: yuanxiangzhen@163.com
Affiliation:  Shanghai Tongren Hospital
Key inclusion & exclusion criteria
Inclusion criteria: (1) The patients meet the diagnostic criteria of Wilson's disease, including the newly diagnosed patient and the previously diagnosed patient.
(2) The patient with Wilson's disease are beteen 10 years old and 50 years old.
(3) The patients or their guardians shall give informed consent and sign the informed consent.

Exclusion criteria: The patients cannot tolerate magnetic resonance examination or have metal implants in the body, which is not suitable for magnetic resonance examination.

Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Wilson’s disease
Intervention(s)
Gold Standard:The main clinical diagnostic criteria: 1) liver disease history, liver disease symptoms or extravertebral system symptoms; 2) serum ceruloplasmin was significantly decreased and/or liver copper increased; 3) corneal Kayser-Fleischer ring; 4) positive family history.;Index test:Quantitative susceptibility mapping;
Primary Outcome(s)
magnetic susceptibility;SEN, SPE, ROC;
Secondary Outcome(s)
Copper ion concentration;Iron ion concentration;
Secondary ID(s)
Source(s) of Monetary Support
Self-funding
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 17/04/2019
Contact:
Lihua Bai
Results
Results available:
Date Posted:
Date Completed:
URL:
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