NCT04477967

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
24mo left

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Oct 2018Jul 2028

Study Start

First participant enrolled

October 1, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 20, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
7.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Expected
Last Updated

July 20, 2020

Status Verified

July 1, 2020

Enrollment Period

2.3 years

First QC Date

July 8, 2020

Last Update Submit

July 15, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    2 years

  • Integrated health data platform

    Collect patient clinical test information and establish diagnostic database.

    2 years

Interventions

There are no interventions because it is a protocol study

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Children diagnosed with end-stage liver disease.
  • Liver transplantation in our hospital.
  • informed patient consent.
  • long-term follow-up in our hospital.

You may not qualify if:

  • No fixed contact information, difficult to follow up the patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400014, China

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Liver DiseasesPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Digestive System DiseasesLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dean

Study Record Dates

First Submitted

July 8, 2020

First Posted

July 20, 2020

Study Start

October 1, 2018

Primary Completion

January 1, 2021

Study Completion (Estimated)

July 1, 2028

Last Updated

July 20, 2020

Record last verified: 2020-07

Locations