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Non-Invasive Characterization of Focal Liver Lesions in Liver Cirrhosis (NICETIES)

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ClinicalTrials.gov Identifier: NCT03746210
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Michael Praktiknjo, University Hospital, Bonn

Tracking Information
First Submitted Date November 14, 2018
First Posted Date November 19, 2018
Last Update Posted Date April 28, 2021
Actual Study Start Date January 1, 2016
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 15, 2018)
Diagnostic accuracy [ Time Frame: 1 year ]
The diagnostic accuracy of non-invasive imaging of focal liver lesions in liver cirrhosis compared to gold standard (histology, CT and/or MRI)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 15, 2018)
Predictive Value [ Time Frame: up to 5 years ]
The predictive value on mortality and treatment response of non-invasive imaging of focal liver lesions in liver cirrhosis
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Non-Invasive Characterization of Focal Liver Lesions in Liver Cirrhosis
Official Title Non-Invasive Characterization of Focal Liver Lesions in Liver Cirrhosis
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.
Detailed Description

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.

Upon diagnosis multiparametric ultrasound imaging of the lesions as well as sarcopenia parameters are performed for characterization of the lesions. For primary endpoint the results are then analyzed with regard to diagnostic accuracy compared to gold standard (CT, MRI or histology). For secondary endpoint, predictive value of the non-invasive diagnostics are analyzed with regards to mortality and response to treatment.

All work up, treatment and follow up are applied in standard of care fashion.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-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.
Condition Liver Cirrhoses
Intervention Diagnostic Test: Standard diagnostic procedures
B-Mode ultrasound, Duplex sonography, contrast-enhanced ultrasound, elastography, CT, MRI, anthropometrics
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 15, 2018)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2027
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • all patients with focal liver lesions and liver cirrhosis

Exclusion Criteria:

  • no consent
  • under 18 years
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Michael Praktiknjo, MD +4922828715770 michael.praktiknjo@ukbonn.de
Contact: Johannes Chang, MD +4922828715770 johannes.chang@ukbonn.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03746210
Other Study ID Numbers NICETIES
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Michael Praktiknjo, University Hospital, Bonn
Study Sponsor University Hospital, Bonn
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital, Bonn
Verification Date April 2021