NCT03898765

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 2, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

April 1, 2019

Last Update Submit

April 1, 2019

Conditions

Hepatobiliary DiseaseBiliary AtresiaNeonatal Cholestasis

Keywords

Dry blood spot testBiliary Atresia

Outcome Measures

Primary Outcomes (1)

  • Suspected BA

    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

Study Arms (1)

Experimental：Dry blood spot screening

EXPERIMENTAL
Diagnostic Test: Dry blood spot screening

Interventions

Dry blood spot screeningDIAGNOSTIC_TEST

Dry blood spot measurement of biomarker for screening biliary atresia

Experimental：Dry blood spot screening

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Neonates born in Shanghai

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, China

Location

MeSH Terms

Conditions

Digestive System DiseasesBiliary Atresia

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Wei Cai, Pro

    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    STUDY DIRECTOR

Central Study Contacts

Wei Cai, Pro

CONTACT

0821-25076441caiw204@sjtu.edu.cn

Jie Wen, Dr

CONTACT

0821-25076449wenjie19860813@live.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2019

First Posted

April 2, 2019

Study Start

April 1, 2019

Primary Completion

March 31, 2020

Study Completion

December 31, 2021

Last Updated

April 2, 2019

Record last verified: 2019-03

Locations

CN(1)