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
Other: Risk model of tumor relapse
High risk factor model of tumor relapse after liver transplantation
Other Names:
  • Risk model
Non-relapse
Non-relapse of tumor within two years after liver transplantation
Other: Risk model of tumor relapse
High risk factor model of tumor relapse after liver transplantation
Other Names:
  • Risk model

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

Zhejiang University

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.

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