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

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ClinicalTrials.gov Identifier: NCT03898765
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Hepatobiliary Disease Biliary Atresia Neonatal Cholestasis Diagnostic Test: Dry blood spot screening Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Dry Blood Spot Screening Test for Biliary Atresia and Other Cholestasis Diseases
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Neonates born in Shanghai

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898765


Contacts
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Contact: Wei Cai, Pro 0821-25076441 caiw204@sjtu.edu.cn
Contact: Jie Wen, Dr 0821-25076449 wenjie19860813@live.cn

Locations
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China
Shanghai Xinhua Hospital, affiliated to Shanghai Jiao Tong University, School of Medicine
Shanghai, China
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Study Director: Wei Cai, Pro Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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Responsible Party: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03898765     History of Changes
Other Study ID Numbers: XH-BA-1
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
Dry blood spot test
Biliary Atresia

Additional relevant MeSH terms:
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Cholestasis
Biliary Atresia
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Digestive System Abnormalities
Congenital Abnormalities