NCT03746210

Brief Summary

This study aims to analyze non-invasive characterization focal liver lesions in patients with liver cirrhosis. The diagnostic accuracy and predictive value of non-invasive methods is studied.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress86%
Jan 2016Dec 2027

Study Start

First participant enrolled

January 1, 2016

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

10 years

First QC Date

November 14, 2018

Last Update Submit

May 17, 2022

Conditions

Liver Cirrhoses

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy

    The diagnostic accuracy of non-invasive imaging of focal liver lesions in liver cirrhosis compared to gold standard (histology, CT and/or MRI)

    1 year

Secondary Outcomes (1)

  • Predictive Value

    up to 5 years

Interventions

Standard diagnostic proceduresDIAGNOSTIC_TEST

B-Mode ultrasound, Duplex sonography, contrast-enhanced ultrasound, elastography, CT, MRI, anthropometrics

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study includes all adult patients in our institution with liver cirrhosis and diagnosis of focal liver lesions. Non-invasive charaterization (multiparametric ultrasound, sarcopenia assessment) and standard of care work up, treatment and follow up is applied to all patients.

You may qualify if:

  • all patients with focal liver lesions and liver cirrhosis

You may not qualify if:

  • no consent
  • under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bonn

Bonn, Germany

RECRUITING

Central Study Contacts

Michael Praktiknjo, MD

CONTACT

+4922828715770michael.praktiknjo@ukbonn.de

Johannes Chang, MD

CONTACT

+4922828715770johannes.chang@ukbonn.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator / Medical Doctor

Study Record Dates

First Submitted

November 14, 2018

First Posted

November 19, 2018

Study Start

January 1, 2016

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Last Updated

May 18, 2022

Record last verified: 2022-05

Locations

DE(1)