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Main
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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. |
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Register:
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ChiCTR |
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Last refreshed on:
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6 February 2023 |
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Main ID: |
ChiCTR2200055459 |
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Date of registration:
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2022-01-10 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Establishment of a diagnostic model of biliary atresia ultrasound combined with MMP-7: a multicenter diagnostic accuracy study
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Scientific title:
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Establishment of a diagnostic model of biliary atresia ultrasound combined with MMP-7: a multicenter diagnostic accuracy study |
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Date of first enrolment:
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2022-02-01 |
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Target sample size:
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Target condition:150;Difficult condition:150 |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=147944 |
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Study type:
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Diagnostic test |
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Study design:
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Factorial
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Phase:
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0
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Countries of recruitment
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China
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Contacts
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Name:
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Jiang Jing
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Address:
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399 Wanyuan Road, Minhang District, Shanghai
201102
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Telephone:
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+86 13795383323 |
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Email:
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jocelyn_17@163.com |
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Affiliation:
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Pediatric Hospital Affiliated to Fudan University |
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Name:
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Zheng Shan
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Address:
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399 Wanyuan Road, Minhang District, Shanghai
201102
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Telephone:
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+86 15900898826 |
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Email:
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szheng@shmu.edu.cn |
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Affiliation:
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Pediatric Hospital Affiliated to Fudan University |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Aged <=150 days, gender is not limited;
2. Cholestatic diagnostic criteria: serum total bilirubin <85umol/L, but serum direct bilirubin >=17umol/L; or serum total bilirubin >=85umol/L, but direct bilirubin accounts for more than 20% of total bilirubin;
3. Gestational age >= 28 weeks, birth weight >= 1000g;
4. Sign the informed consent.
Exclusion criteria: 1. There was a history of severe hypoxia at birth, and the 5-minute Apgar score was less than 5;
2. According to clinical manifestations, laboratory tests, etc., diagnosed with allergic diseases, inflammatory bowel diseases, and infectious diseases;
3. Other serious congenital malformations and immunodeficiencies;
4. It is impossible to complete the sampling before the gold standard diagnosis;
5. Give up further diagnosis and treatment, unable to obtain a definite diagnosis.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Biliary atresia
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Intervention(s)
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Gold Standard:Biliary tract exploration and liver pathology.;Index test:MMP-7, ultrasound, MMP-7 and ultrasound combined diagnostic model.;
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Primary Outcome(s)
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MMP-7;Ultrasound;sensitivity, specificity, accuracy;
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Source(s) of Monetary Support
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Hospital Fund
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Ethics review
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Status: Approved
Approval date: 08/12/2021
Contact:
Qian Liling
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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