Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to validate the Disease Severity Index (DSI) from the HepQuant SHUNT Liver Diagnostic Kit (Test) for likelihood of large esophageal varices.


Clinical Trial Description

The purpose of this study is to validate the Disease Severity Index (DSI) from the HepQuant SHUNT Liver Diagnostic Kit (Test) for likelihood of large esophageal varices. Our HALT-C Training dataset demonstrated that the DSI 18.3 had sensitivity 95%, specificity 54%, PPV 19%, NPV >99%, negative likelihood ratio (NLR) 0.09, and positive likelihood ratio (PLR) 2.09 for large varices. To validate DSI 18.3 as a cutoff for large varices, we will enroll 420 subjects with chronic liver disease (CLD) of mixed etiologies from 15 to 25 US clinical centers (CLD Validation dataset). The target prevalence of large varices is ≥20%. Each subject will have been scheduled for an esophago-gastro-duodenoscopy (EGD) as part of their standard of care for either variceal or non-variceal indications. Enrolled subjects will undergo standard clinical assessment, laboratory tests, and the HepQuant SHUNT Test. The EGD will be performed within 6 weeks following the HepQuant SHUNT Test. The relationship of DSI to large varices will be analyzed by univariate and multivariate logistic regression analyses, AUROC, and linear and nonlinear regression and correlation coefficients. Diagnostic performance of the DSI cutoff will be defined in the CLD Validation dataset and validated for likelihood of large esophageal varices. The validated DSI cutoff will identify subjects who are either unlikely or likely to have large esophageal varices. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03583996
Study type Interventional
Source HepQuant, LLC
Contact
Status Completed
Phase N/A
Start date January 23, 2019
Completion date May 7, 2021

See also
  Status Clinical Trial Phase
Completed NCT03704792 - Validation of the Second Generation of the Controlled Attenuation Parameter (CAP) Using the MRI-PDFF as Reference N/A
Terminated NCT02949375 - Trial to Examine the Effect of Two Doses of GRI-0621 in Patients With Chronic Liver Disease Phase 2
Active, not recruiting NCT01205074 - ¹³C-Methacetin Breath Test (MBT) Methodology Study Phase 2/Phase 3
Completed NCT00756171 - Colesevelam Versus Placebo in Cholestatic Pruritus Phase 2/Phase 3
Completed NCT01195181 - Different PEG-interferon and Ribavirin Schedules for Chronic Hepatitis C in the Real Clinical Practice. Phase 4
Completed NCT05044663 - Liver and Splenic Stiffness in Predicting Esophageal Varices Needing Treatment in NASH Related Compensated Advanced Chronic Liver Disease.
Recruiting NCT04588077 - Comparison Between 2-dose Versus 3-dose Regimens of Heplisav B in Cirrhosis Phase 4
Recruiting NCT04802954 - Risk Stratification of Hepatocarcinogenesis Using a Deep Learning Based Clinical, Biological and Ultrasound Model in High-risk Patients N/A
Recruiting NCT04622449 - Etiopathogenesis of Anemia in Chronic Liver Disease
Enrolling by invitation NCT05836246 - The Development of Quantitative Ultrasound Imaging Software Platform
Completed NCT03087344 - Postprandial Liver and Spleen Stiffness Measurements in the Noninvasive Diagnosis of Cirrhosis N/A
Completed NCT04751045 - Comparison and Outcomes of Endoscopic Ultrasound Liver Biopsies Versus Percutaneous Liver Biopsies N/A
Not yet recruiting NCT04526548 - A Diagnostic Study on Patients With Drug-induced Liver Injury
Withdrawn NCT02899325 - FDGal PET/CT to Detect Hepatocellular Carcinoma
Terminated NCT02530567 - Non-invasive Evaluation of Portal Pressure by MRI N/A
Suspended NCT02650011 - Clinical Features and Natural History of Acute-on-Chronic Liver Failure in Korean Patients With Chronic Liver Disease
Completed NCT01851252 - MBT Versus HVPG in Identifying Responders to Portal Hypertension Therapy Phase 1
Terminated NCT01756690 - Predicting Lung Injury From Transfusion in Patients With Liver Disease N/A
Completed NCT01600105 - Detection of Liver Fibrosis With Magnetic Resonance Imaging (MRI) Phase 4
Completed NCT01008293 - Effect of Probiotics in Treatment of Minimal Hepatic Encephalopathy (MHE) and Health Related Quality of Life Phase 2/Phase 3