Liver DiseasesNCT04477967
Design and Implementation of the Pediatric Liver Transplantation Biobank
An observational study of Liver Diseases and Liver Transplant; Complications, run by Children's Hospital of Chongqing Medical University at 1 site in China.
Trial summary
The purpose of the pediatric liver transplant biobank is to systematically collect clinical specimens from pediatric end-stage liver disease. It is expected to contribute to the research and development of paediatric end-stage liver disease in the future. Read more about this study
- Who is it for?
- Ages 1 month to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Diseases, Liver Transplant; Complications, Pediatric ALL
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2018to 1 Jul 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 month to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children with end-stage liver disease who undergo liver transplantation in our hospital. Obtain their or their parents' informed consent before the project starts.
Who may be able to join
- Children diagnosed with end-stage liver disease.
- Liver transplantation in our hospital.
- informed patient consent.
- long-term follow-up in our hospital.
Who cannot join
- No fixed contact information, difficult to follow up the patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400014
Yao Zhao, postdoctor
About this study
Official title: Children's Hospital of Chongqing Medical University
The purpose of the pediatric liver transplant biobank is to systematically collect clinical specimens from pediatric end-stage liver disease. It is expected to contribute to the research and development of paediatric end-stage liver disease in the future.
- Being tested
- No intervention
- Medical subject headings
- Liver Diseases, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There are no interventions because it is a protocol study
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological sample bank
A repository of biological samples from patients who will join the project, will be organised at the biobank center of the Children's Hospital of Chongqing Medical University(CHCMU) under the responsibility of the experienced staff at the Department of Hepatic.
Measured: 2 years
Integrated health data platform
Collect patient clinical test information and establish diagnostic database.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 Oct 2018
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- 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
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiu Li, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477967
- Sponsor's protocol ID
- 2018（120）
- Status last verified
- Jul 2020
- First submitted
- 8 Jul 2020
- Last updated
- 20 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xiang Z, Wang R, Lu Y, Li Y, Wang H, Xiong Q, Dai X, Guo H, Deng Y, Le Y, Zhang M, Zhao Y. Study Protocol: Design and Implementation of the Pediatric Liver Transplantation Biobank. Biopreserv Biobank. 2021 Apr;19(2):111-118. doi: 10.1089/bio.2020.0128. Epub 2021 Apr 12.
PubMed 33847526
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children's Hospital of Chongqing Medical University
- ClinicalTrials.gov ID
- NCT04477967
- Acronym / sponsor ID
- 2018（120）
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Children's Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 20 Jul 2020 (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.
The purpose of the pediatric liver transplant biobank is to systematically collect clinical specimens from pediatric end-stage liver disease. It is expected to contribute to the research and development of paediatric end-stage liver disease in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children with end-stage liver disease who undergo liver transplantation in our hospital. Obtain their or their parents' informed consent before the project starts.
Key inclusion criteria (4 listed)
- Children diagnosed with end-stage liver disease.
- Liver transplantation in our hospital.
- informed patient consent.
- long-term follow-up in our hospital.
Key exclusion criteria (1 listed)
- No fixed contact information, difficult to follow up the patients.
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 |
|---|---|---|
| No interventionThere are no interventions because it is a protocol study | Other | – |
Primary outcome
Biological sample bank
Time frame: 2 years
A repository of biological samples from patients who will join the project, will be organised at the biobank center of the Children's Hospital of Chongqing Medical University(CHCMU) under the responsibility of the experienced staff at the Department of Hepatic.
Integrated health data platform
Time frame: 2 years
Collect patient clinical test information and establish diagnostic database.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
- Derived from this study: PubMed 33847526Xiang Z, Wang R, Lu Y, Li Y, Wang H, Xiong Q, Dai X, Guo H, Deng Y, Le Y, Zhang M, Zhao Y. Study Protocol: Design and Implementation of the Pediatric Liver Transplantation Biobank. Biopreserv Biobank. 2021 Apr;19(2):111-118. doi: 10.1089/bio.2020.0128. Epub 2021 Apr 12.
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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.
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 Liver Diseases and Liver Transplant; Complications, run by Children's Hospital of Chongqing Medical University 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 4 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: looking for participants now, as of the sponsor's last update on 20 Jul 2020. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiang Zheng (17723191712, xiangzheng061@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological sample bank (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04477967, which also lists 1 linked publication.
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 20 Jul 2020.