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NCT03708705 Clinical Trial

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

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03708705
Other study ID # ZJUXU1177
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 20, 2018
Est. completion date July 1, 2020

Study information
Verified date October 2018
Source Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 500
Est. completion date July 1, 2020
Est. primary completion date May 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

transplants for HCC

Exclusion Criteria:

Liver transplantation due to other disease

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Risk model of tumor relapse
High risk factor model of tumor relapse after liver transplantation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Zhejiang University

Outcome
Type Measure Description Time frame Safety issue
Primary relapse rate of tumor two years
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