Dry Blood Spot Screening Test for Biliary Atresia（DBS-SCReBA）

Biliary Atresia Clinical Trial

Official title:

Dry Blood Spot Screening Test for Biliary Atresia and Other Cholestasis Diseases

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03898765
• Other study ID #: XH-BA-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2019
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Wei Cai, Pro
• Phone: 0821-25076441
• Email: caiw204[@]sjtu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Our study aims to develop a screening test for biliary atresia (BA) using dry blood spot to improve patient survival by early diagnosis. Newborn screening dry blood spot will be examined for the direct bilirubin (DB), γ-GT or matrix metalloproteinase-7 (MMP-7) levels. These findings will promote early diagnosis for BA and hence improve the survival.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20000
• Est. completion date: December 31, 2021
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Neonates born in Shanghai

Exclusion Criteria:

• Subjects who do not agree with study protocol

• Subjects who join other clinical trials

Related Conditions & MeSH terms

• Biliary Atresia
• Cholestasis
• Hepatobiliary Disease
• Neonatal Cholestasis

Intervention

Diagnostic Test:
• Dry blood spot screening
Dry blood spot measurement of biomarker for screening biliary atresia

Locations

Country	Name	City	State
China	Shanghai Xinhua Hospital, affiliated to Shanghai Jiao Tong University, School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suspected BA	MMP-7 with or without other one or two biomarkers (DB and ?-GT) > upper limit of normal value	Three to Seven days after birth