NCT03981848

Brief Summary

The purpose of this study is to establish a non-invasive radiomics method to filter high recurrent-risk liver transplantation recipient population

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

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

June 10, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2019

Completed
20 days until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

June 11, 2019

Status Verified

June 1, 2019

Enrollment Period

2 years

First QC Date

June 10, 2019

Last Update Submit

June 10, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • tumor recurrent status

    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

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:

  • All patients had postoperative pathological diagnosis of HCC
  • All patients had underwent contrast-enhanced MRI scan within 2 weeks before liver transplantation

You may not qualify if:

  • patients whose pathological diagnosis is not HCC
  • patients whose CT images were affected by strong imaging artifacts, i.e. artifacts obscuring more than 10% of whole volume of interest
  • patients whose clinical data or CT images were missing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

June 10, 2019

First Posted

June 11, 2019

Study Start

July 1, 2019

Primary Completion

July 1, 2021

Study Completion

December 1, 2021

Last Updated

June 11, 2019

Record last verified: 2019-06