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

NCT ID: NCT03898765

Last Updated: 2019-04-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2021-12-31

Brief 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.

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.

Conditions

Hepatobiliary Disease; Biliary Atresia; Neonatal Cholestasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Experimental：Dry blood spot screening

Group Type: EXPERIMENTAL

Dry blood spot screening

Intervention Type: DIAGNOSTIC_TEST

Dry blood spot measurement of biomarker for screening biliary atresia

Interventions

Dry blood spot screening

Dry blood spot measurement of biomarker for screening biliary atresia

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Neonates born in Shanghai

Exclusion Criteria

• Subjects who do not agree with study protocol
• Subjects who join other clinical trials

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Cai, Pro

Role: STUDY_DIRECTOR

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Locations

Shanghai Xinhua Hospital, affiliated to Shanghai Jiao Tong University, School of Medicine

Shanghai, , China

Countries

China

Central Contacts

Wei Cai, Pro

Role: CONTACT

caiw204@sjtu.edu.cn

0821-25076441

Jie Wen, Dr

Role: CONTACT

wenjie19860813@live.cn

0821-25076449

Other Identifiers

XH-BA-1

Identifier Type: -

Identifier Source: org_study_id