Dry Blood Spot Screening Test for Biliary Atresia（DBS-SCReBA）
Dry Blood Spot Screening Test for Biliary Atresia and Other Cholestasis Diseases
Study Overview
Status
Intervention / Treatment
Detailed Description
BA accounts for approximately 60% of the liver transplantations in infants younger than 1 year of age. The diagnosis of BA remains a clinical challenge because affected neonates have signs, symptoms, and serum liver biochemistry that are also seen in those with other causes of neonatal cholestasis.
The success of the Kasai procedure is varied, but a good outcome is correlated with an early diagnosis. Unfortunately, most BA are usually identified later and the average age at surgery is about 60 days. To address this problem, some research groups screen infants for the pale stools or measure bilirubin level in the serum. However, these screening programs have not yet to be implemented because of several reasons. Recently, the relative abundance of serum MMP-7 was suggested to have discriminatory features for infants with BA. Nevertheless, whether the level of MMP-7 elevates in newborn dry blood spot of BA is still undefined. In this study, we will explore a screening strategy based on DB, γ-GT or MMP-7 measurement in newborn screening blood spot, and identify whether DB , γ-GT or MMP-7 measurement in the newborn period could be sensitive and specific for BA.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Shanghai, China
- Shanghai Xinhua Hospital, affiliated to Shanghai Jiao Tong University, School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Neonates born in Shanghai
Exclusion Criteria:
- Subjects who do not agree with study protocol
- Subjects who join other clinical trials
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental：Dry blood spot screening
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Dry blood spot measurement of biomarker for screening biliary atresia
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Suspected BA
Time Frame: Three to Seven days after birth
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MMP-7 with or without other one or two biomarkers (DB and γ-GT) > upper limit of normal value
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Three to Seven days after birth
|
Collaborators and Investigators
Investigators
- Study Director: Wei Cai, Pro, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- XH-BA-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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