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

April 1, 2019 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Unknown

Conditions

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

Interventional

Enrollment (Anticipated)

20000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Experimental：Dry blood spot screening
Diagnostic test: Dry blood spot screening
Dry blood spot measurement of biomarker for screening biliary atresia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Suspected BA
Time Frame: Three to Seven days after birth
MMP-7 with or without other one or two biomarkers (DB and γ-GT) > upper limit of normal value
Three to Seven days after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Study Director: Wei Cai, Pro, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2019

Primary Completion (Anticipated)

March 31, 2020

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

April 1, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (Actual)

April 2, 2019

Study Record Updates

Last Update Posted (Actual)

April 2, 2019

Last Update Submitted That Met QC Criteria

April 1, 2019

Last Verified

March 1, 2019

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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