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

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

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03898765
Enrollment
0
Registered
2019-04-02
Start date
2019-04-01
Completion date
2021-12-31
Last updated
2026-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Atresia, Hepatobiliary Disease, Neonatal Cholestasis

Keywords

Dry blood spot test, Biliary Atresia

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.

Interventions

Dry blood spot measurement of biomarker for screening biliary atresia

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Neonates born in Shanghai

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Suspected BAThree to Seven days after birthMMP-7 with or without other one or two biomarkers (DB and γ-GT) \> upper limit of normal value

Countries

China

Contacts

STUDY_DIRECTORWei Cai, Pro

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 1, 2026