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Liquid Biopsy-based Monitoring System for Relapse of HCC After Liver Transplantation: A Multi-center and Prospective Study

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ClinicalTrials.gov Identifier: NCT03708705
Recruitment Status : Unknown
Verified October 2018 by Xiao Xu, Zhejiang University.
Recruitment status was:  Not yet recruiting
First Posted : October 17, 2018
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Xiao Xu, Zhejiang University

Study Description
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Brief Summary:
This study aims to develop a novel, reliable, liquid biopsy-based biomarker system for relapse of HCC associated with hepatitis B after liver transplantation.

Condition or disease Intervention/treatment
Hepatocellular Carcinoma Other: Risk model of tumor relapse

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 Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Liquid Biopsy-based Monitoring System for Relapse of Hepatocellular Carcinoma Associated With Hepatitis B After Liver Transplantation: A Multi-center and Prospective Study
Estimated Study Start Date : November 20, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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 Name: 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 Name: Risk model


Outcome Measures
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Primary Outcome Measures :
  1. relapse rate of tumor [ Time Frame: two years ]

Biospecimen Retention:   Samples With DNA
Blood and tissue samples.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
hospitalization patients
Criteria

Inclusion Criteria:

transplants for HCC

Exclusion Criteria:

Liver transplantation due to other disease

Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Xiao Xu, professor, Zhejiang University
ClinicalTrials.gov Identifier: NCT03708705    
Other Study ID Numbers: ZJUXU1177
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Analytic Code
Time Frame: Two years

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases