Liquid Biopsy-based Monitoring System for Relapse of HCC After Liver Transplantation: A Multi-center and Prospective Study
October 18, 2018 updated by: Xiao Xu, Zhejiang University
Liquid Biopsy-based Monitoring System for Relapse of Hepatocellular Carcinoma Associated With Hepatitis B After Liver Transplantation: A Multi-center and Prospective Study
This study aims to develop a novel, reliable, liquid biopsy-based biomarker system for relapse of HCC associated with hepatitis B after liver transplantation.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Relapse of hepatocellular carcinoma (HCC) is one of the leading causes of death after liver transplantation (LT).
Detection of cancer at an earlier stage of the disease can be critical to improve patient survival.
Liquid biopsy is a revolutionary technique that is opening previously unexpected perspectives.
It consists of circulating extracellular vesicles, nucleic acids (DNA and RNA) and circulating tumor cells.
The detection and isolation of circulating tumor cells, circulating tumor DNA and exosomes, as a source of genomic and proteomic information in patients with cancer.
Regarding these promising and potential transformative tools, as well as the issues still needed to be addressed for adopting various liquid biopsy approaches into clinical practice.
This study aims to develop a novel, reliable, liquid biopsy-based biomarker system for relapse of HCC associated with hepatitis B after liver transplantation.
Study Type
Observational
Enrollment (Anticipated)
500
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
hospitalization patients
Description
Inclusion Criteria:
transplants for HCC
Exclusion Criteria:
Liver transplantation due to other disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Relapse
Relapse of tumor within two years after liver transplantation
|
High risk factor model of tumor relapse after liver transplantation
Other Names:
|
|
Non-relapse
Non-relapse of tumor within two years after liver transplantation
|
High risk factor model of tumor relapse after liver transplantation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
relapse rate of tumor
Time Frame: two years
|
two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 20, 2018
Primary Completion (Anticipated)
May 1, 2020
Study Completion (Anticipated)
July 1, 2020
Study Registration Dates
First Submitted
October 13, 2018
First Submitted That Met QC Criteria
October 16, 2018
First Posted (Actual)
October 17, 2018
Study Record Updates
Last Update Posted (Actual)
October 19, 2018
Last Update Submitted That Met QC Criteria
October 18, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZJUXU1177
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Sharing Time Frame
Two years
IPD Sharing Supporting Information Type
- Study Protocol
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.