Development and Validation of a Multi-target, Blood-based NAFLD Diagnosis Test

NCT05108415 | Unknown

• 1 other identifier: NAFLD_001
• Study Type: observational
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

Multi-omics approach was used to identify patterns of serological biomarkers to diagnose NAFLD. The purpose of this study is to develop and validate a blood-based assay to diagnose NAFLD by collecting blood sample from healthy patients undergoing routine screening ultrasonography and from patients recently diagnosed with NAFLD.

Conditions

NAFLD; NASH - Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• Confirmative of Number of Participants with NAFLD Diagnosis

  Confirmative of number of Participants with NAFLD diagnosis in patients undergoing routine screening ultrasonography, or post-ultrasonography.

  2 months

Study Arms (3)

Cohort A

Blood specimen collection. Study samples must be collected prior to any treatment.

Cohort B

Blood specimen collection. Samples must be collected prior to perform the ultrasonography.

Cohort C

Blood specimen collection. Study samples must be collected prior to any treatment.

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

You may qualify if:

• years of age
• Recently completed ultrasonography examination.
• Recently diagnosed with (or strong clinical suspicion for) primary NAFLD.
• At least 7 days before but no more than 2 months after the most recent ultrasonography
• Able and willing to provide blood samples per protocol
• Able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study

You may not qualify if:

• Alcohol abuse (weekly ethanol consumption: \>140 g for men and \>70 g for women) in the past year.
• Personal history of NAFLD (other than most recent diagnosis)
• Ultrasonography within the previous 9 years (other than most recent diagnosis)
• A history of fatty liver or other liver diseases such as autoimmune hepatitis and drug-induced liver disease.
• Have a medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
• Have participated or be currently participating in a clinical research study in which an experimental medication has been administered during the 60 days up to and including the date of providing informed consent or may be administered through the time of the ultrasonography.
• If female, known to be pregnant.
• COHORT B
• years of age
• Planning to undergo a screening ultrasonography within 2 months after providing signed informed consent
• Able and willing to provide blood samples per protocol
• Able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study
• Alcohol abuse (weekly ethanol consumption: \>140 g for men and \>70 g for women) in the past year.
• Personal history of NAFLD
• Ultrasonography within the previous 9 years

Sponsors & Collaborators

• HBI Solutions Inc.: lead
• mProbe Inc.: collaborator

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Central Study Contacts

James Schilling

CONTACT

6504279198; admin@mprobe.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 5, 2021
• Study Start: May 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: March 23, 2023

Record last verified: 2023-03