Biliary AtresiaNCT03842150
Development and Validation of a Screening Score for the Biliary Atresia in Infantile Cholestasis: A Prospective Study
An observational study of Biliary Atresia and Neonatal Cholestasis, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Better survival and prognosis of biliary atresia (BA) depend on early diagnosis and timely Kasai portoenterostomy. Identifying BA from other causes of infantile cholestasis at early stage of the disease still remains a major challenge. Read more about this study
- Who is it for?
- Ages 1 day to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Biliary Atresia, Neonatal Cholestasis, Infantile Hepatitis Syndrome
- What is being tested?
- biliary atresia screen score
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2014to 31 Dec 2025
- Phase
- Observational
- 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 1 day to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: infants with cholestasis inclduing biliary atresia
Who may be able to join
- Clinical diagnosis of neonatal cholestasis Age at first visit less than 90 days after birth
Who cannot join
- Severe congenital malformation Subjects with missing data
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Yongjun Zhang, doctor
About this study
Better survival and prognosis of biliary atresia (BA) depend on early diagnosis and timely Kasai portoenterostomy. Identifying BA from other causes of infantile cholestasis at early stage of the disease still remains a major challenge. In this study, the investigators aim to develop and validate a scoring system to screen BA in infants with cholestasis.
- Being tested
- biliary atresia screen score
- Medical subject headings
- Biliary Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biliary atresia screen scoreDiagnostic test
The investigators aim to develop a scoring system according to clinical, laboratory, imaging features of biliary atresia in the derivation dataset and tested in the validation datasets.
| Study group | Role | What they receive |
|---|---|---|
| derivation cohort | Not described Receives: Diagnostic Test: biliary atresia screen score | |
| validation cohort | Not described Receives: Diagnostic Test: biliary atresia screen score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development and Validation a Screening Score for the biliary atresia in infantile cholestasis
Developed a scoring system according to clinical, laboratory, imaging features of BA and test it in the clinical work. The score system might including clay stool, γ-glutamyl transpeptadase, the results of ultrasound and subscales selected for logistic regression. The total score would sum all the subscales up.The investigators grade the patients with the cholestasis screen score to identify patients with biliary atresia. Patients with score ≤ 15 points considered to be the low-risk group, and patients with risk score > 15 points considered the high-risk group, and the score model has no maximum or minimum value.
Measured: 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Jun 2014
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary AtresiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842150
- Sponsor's protocol ID
- XH-19-001
- Status last verified
- Jan 2021
- First submitted
- 13 Feb 2019
- Last updated
- 28 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators plan to share all the individual participant data information available to our cooperative hospitals through emails
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Screening Score for the Biliary Atresia in Infantile Cholestasis: A Prospective Study
- ClinicalTrials.gov ID
- NCT03842150
- Acronym / sponsor ID
- XH-19-001
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Feb 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.
Better survival and prognosis of biliary atresia (BA) depend on early diagnosis and timely Kasai portoenterostomy. Identifying BA from other causes of infantile cholestasis at early stage of the disease still remains a major challenge. In this study, the investigators aim to develop and validate a scoring system to screen BA in infants with cholestasis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| derivation cohort | – | Diagnostic Test: biliary atresia screen score |
| validation cohort | – | Diagnostic Test: biliary atresia screen score |
Who may qualify
- Ages
- 1 day to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- infants with cholestasis inclduing biliary atresia
Key inclusion criteria (1 listed)
- Clinical diagnosis of neonatal cholestasis Age at first visit less than 90 days after birth
Key exclusion criteria (1 listed)
- Severe congenital malformation Subjects with missing data
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 |
|---|---|---|
| biliary atresia screen scoreThe investigators aim to develop a scoring system according to clinical, laboratory, imaging features of biliary atresia in the derivation dataset and tested in the validation datasets. | Diagnostic test | derivation cohort, validation cohort |
Primary outcome
Development and Validation a Screening Score for the biliary atresia in infantile cholestasis
Time frame: 1 weeks
Developed a scoring system according to clinical, laboratory, imaging features of BA and test it in the clinical work. The score system might including clay stool, γ-glutamyl transpeptadase, the results of ultrasound and subscales selected for logistic regression. The total score would sum all the subscales up.The investigators grade the patients with the cholestasis screen score to identify patients with biliary atresia. Patients with score ≤ 15 points considered to be the low-risk group, and patients with risk score > 15 points considered the high-risk group, and the score model has no maximum or minimum value.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Individual participant dataSharing planned: Undecided. The investigators plan to share all the individual participant data information available to our cooperative hospitals through emails
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Atresia and Neonatal Cholestasis, 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 1 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: status not confirmed, as of the sponsor's last update on 28 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongjun Zhang, doctor (+8602125078310, zhangyongjun@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development and Validation a Screening Score for the biliary atresia in infantile cholestasis (time frame: 1 weeks). 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 28 Dec 2022.