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

Blood Specimen Collection Study for NAFLD

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.

Study Overview

• Status: Not yet recruiting
• Conditions: NAFLD; NASH - Nonalcoholic Steatohepatitis

Detailed Description

Accurate diagnosis of NAFLD combined with effective treatment improves survival and quality of life. 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 for accurate diagnosis of NAFLD. The study will collect blood sample from healthy patients undergoing routine screening ultrasonography and from patients recently diagnosed with NAFLD. A blood-based test for NAFLD could offer an accurate, convenient, and patient-friendly screening option for current and future generations, and, in doing so, could save and improve lives by increasing adherence and accurate diagnosis.

Three types of patients in this study:

Cohort A:

People ages 20-85 who have been recently diagnosed with (or strong clinical suspicion for) NAFLD. Blood samples must be collected before any treatment has been initiated.

Cohort B:

People ages 20-85 undergoing routine screening ultrasonography for NAFLD as part of their regular medical check-ups. Blood samples must be collected before ultrasonography.

Cohort C:

People ages 20-85 who have been recently diagnosed with (or strong clinical suspicion for) NASH, an extremely advanced form of non-alcoholic fatty liver disease (NAFLD), is defined as hepatic steatosis with inflammation and hepatocyte injury. Blood samples must be collected before any treatment has been initiated.

• Study Type: Observational
• Enrollment (Anticipated): 1500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

Description

COHORT A

Inclusion Criteria:

• 20-85 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

Exclusion Criteria:

• 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

Inclusion Criteria:

• 20-85 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

Exclusion Criteria:

• 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
• 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 C

Inclusion Criteria:

• 20-85 years of age
• Recently completed ultrasonography examination.
• Recently diagnosed with (or strong clinical suspicion for) NASH, an extremely advanced form of non-alcoholic fatty liver disease (NAFLD), defined as hepatic steatosis with inflammation and hepatocyte injury..
• 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

Exclusion Criteria:

• Alcohol abuse (weekly ethanol consumption: >140 g for men and >70 g for women) in the past year.
• Personal history of NAFLD or NASH (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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: HBI Solutions Inc.
• Collaborators: mProbe Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: October 25, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): November 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: NAFLD_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No