NCT03708705

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

November 20, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

October 19, 2018

Status Verified

October 1, 2018

Enrollment Period

1.4 years

First QC Date

October 13, 2018

Last Update Submit

October 18, 2018

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • relapse rate of tumor

    two years

Study Arms (2)

Relapse

Relapse of tumor within two years after liver transplantation

Other: Risk model of tumor relapse

Non-relapse

Non-relapse of tumor within two years after liver transplantation

Other: Risk model of tumor relapse

Interventions

Risk model of tumor relapseOTHER

High risk factor model of tumor relapse after liver transplantation

Also known as: Risk model
Non-relapseRelapse

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hospitalization patients

You may qualify if:

  • transplants for HCC

You may not qualify if:

  • Liver transplantation due to other disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Blood and tissue samples.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

October 13, 2018

First Posted

October 17, 2018

Study Start

November 20, 2018

Primary Completion

May 1, 2020

Study Completion

July 1, 2020

Last Updated

October 19, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, CSR, ANALYTIC CODE
Time Frame
Two years