Validation of the LiverFASt Test and the Associated Fibrosis Staging Scores Compared to Liver Tissue Pathology Via Liver Biopsy

NCT03980912 | Withdrawn

• 1 other identifier: OBVIO-FIB-001
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to assess the diagnostic performance of the LiverFASt Test for assessing fibrosis staging scores compared to the assessment of liver tissue pathology from liver biopsy.

Conditions

NAFLD; NASH

Keywords

LiverFASt; Fibrosis; Steatosis; Activity; Liver Biopsy; Algorithm; LiverFASt select; Liver Disease

Outcome Measures

Primary Outcomes (4)

• Diagnostic Performance of the LiverFASt test for NAFLD

  Diagnostic performance of the LiverFASt Test for NAFLD resulting from liver biopsy based on percent diagnostic agreement using the thresholds of clinical significance outlined below.

  Baseline

• Diagnostic Performance of the LiverFASt test for NAFLD

  Diagnostic performance of the LiverFASt Test for NAFLD resulting from liver biopsy based on percent diagnostic specificity using the thresholds of clinical significance outlined below.

  Baseline

• Diagnostic Performance of the LiverFASt test for NAFLD

  Diagnostic performance of the LiverFASt Test for NAFLD resulting from liver biopsy based on percent diagnostic sensitivity using the thresholds of clinical significance outlined below.

  Baseline

• Diagnostic Performance of the LiverFASt test for NAFLD

  Diagnostic performance of the LiverFASt Test for NAFLD resulting from liver biopsy based on percent diagnostic accuracy using the thresholds of clinical significance outlined below.

  Baseline

Secondary Outcomes (5)

• Diagnostic Performance of the LiverFASt test for NASH

  Baseline

• Diagnostic Performance of the LiverFASt test for NASH

  Baseline

• Diagnostic Performance of the LiverFASt test for NASH

  Baseline

• Diagnostic Performance of the LiverFASt test for NASH

  Baseline

• Diagnostic Performance of the LiverFASt test for NASH

  Baseline

Interventions

LiverFASt DIAGNOSTIC_TEST

LiverFASt™ is a blood based diagnostic test utilizing a patented algorithm to determine presence and the progression of liver disease. The test is non-invasive, simple, and less expensive than liver biopsy or liver imaging.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include approximately 200 men and women residing in the United States, who are between the ages of 18-80 years. Participants will be liver patients who have undergone liver biopsy within the three months prior to enrollment or are scheduled to undergo a medically indicated liver biopsy.

You may qualify if:

• Aged 18 to 80 years old, inclusive
• Male or Female
• Liver patients who are scheduled to undergo, or have recently undergone, a medically indicated liver biopsy. Patients with a prior biopsy may be included under the following conditions:
• The biopsy was performed within the 3 months prior to enrollment
• A full report is available, including degree of Fibrosis, Activity and Steatosis or residual liver tissue is available for additional review.
• Have a full component of biomarkers available for analysis from a blood sample obtained within 3 months of the date of the biopsy. Participants without a full component of biomarkers may be included if an additional sample for analysis of the missing biomarkers can be obtained within 3 months of the date of the biopsy.
• Required biomarkers include: α2-macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, y-glutamyl transpeptidase (GGT), alanine aminotransferase (ALT), aspartate transaminase (AST), triglycerides, cholesterol, and fasting glucose, collected within 3 months
• Willing and able to allow access to requested data and who were informed and signed the consent form

You may not qualify if:

• Known psychiatric conditions
• Patients who may be uncooperative with the sample collection procedures
• Severe coagulopathy or infection of the hepatic bed
• Extrahepatic biliary obstruction
• Severe cardiovascular disease and/or renal failure
• Malignancy, except for resolved basal-cell carcinoma
• Previous liver transplant
• Suffering with a terminal illness or any other conditions or diseases that the investigator considers inappropriate for study participation

Sponsors & Collaborators

• Fibronostics USA, Inc: lead
• OBVIO HEALTH USA, Inc.: collaborator

Study Sites (1)

ObvioHealth

Orlando, Florida, 32817, United States

Location

Related Links

• Fibronostics

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fibrosis; Fatty Liver; Motor Activity; Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Parth Shah, MD

  OBVIO HEALTH USA, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 10, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: November 1, 2020
• Last Updated: February 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)