Hepatobiliary DiseaseNCT03898765
Dry Blood Spot Screening Test for Biliary Atresia（DBS-SCReBA）
A study testing Dry blood spot screening in people with Hepatobiliary Disease and Biliary Atresia, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatobiliary Disease, Biliary Atresia, Neonatal Cholestasis
- What is being tested?
- Dry blood spot screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Neonates born in Shanghai
Who cannot join
- Subjects who do not agree with study protocol
- Subjects who join other clinical trials
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Xinhua Hospital, affiliated to Shanghai Jiao Tong University, School of Medicine
Shanghai
About this study
Official title: 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.
Read the 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
- Being tested
- Dry blood spot screening
- Keywords
- Dry blood spot test, Biliary Atresia
- Medical subject headings
- Digestive System Diseases, Biliary Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry blood spot screeningDiagnostic test
Dry blood spot measurement of biomarker for screening biliary atresia
| Study group | Role | What they receive |
|---|---|---|
| Experimental：Dry blood spot screening | Experimental | Not described Receives: Diagnostic Test: Dry blood spot screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suspected BA
MMP-7 with or without other one or two biomarkers (DB and γ-GT) > upper limit of normal value
Measured: Three to Seven days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start1 Apr 2019 (estimated)
- Primary completion31 Mar 2020
- Study completion31 Dec 2021
Why it stopped: No Participants has been enrolled. WENJIE, the project lead, has already resigned in 2020，and will no longer be working on this project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatobiliary DiseaseStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Cai, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Wei Cai, Pro, Study director, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898765
- Sponsor's protocol ID
- XH-BA-1
- Status last verified
- Mar 2019
- First submitted
- 1 Apr 2019
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Blood Spot Screening Test for Biliary Atresia and Other Cholestasis Diseases
- ClinicalTrials.gov ID
- NCT03898765
- Acronym / sponsor ID
- XH-BA-1
- Conditions
- Hepatobiliary Disease, Biliary Atresia, Neonatal Cholestasis
- Keywords
- Dry blood spot test, Biliary Atresia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No Participants has been enrolled. WENJIE, the project lead, has already resigned in 2020，and will no longer be working on this project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental：Dry blood spot screening | Experimental | Diagnostic Test: Dry blood spot screening |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Neonates born in Shanghai
Key exclusion criteria (2 listed)
- Subjects who do not agree with study protocol
- Subjects who join other clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry blood spot screeningDry blood spot measurement of biomarker for screening biliary atresia | Diagnostic test | Experimental：Dry blood spot screening |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Cai, Pro study director
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry blood spot screening in people with Hepatobiliary Disease and Biliary Atresia, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suspected BA (time frame: Three to Seven days after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.