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

Sponsor

HBI Solutions Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05108415

Collaborator

mProbe Inc. (Industry)

1,500

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

1500 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Blood Specimen Collection Study for NAFLD

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Confirmative of Number of Participants with NAFLD Diagnosis [2 months]
Confirmative of number of Participants with NAFLD diagnosis in patients undergoing routine screening ultrasonography, or post-ultrasonography.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

HBI Solutions Inc.
mProbe Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

James Shilling, Principal Investigator, HBI Solutions Inc.

ClinicalTrials.gov Identifier:

NCT05108415

Other Study ID Numbers:

NAFLD_001

First Posted:

Nov 5, 2021

Last Update Posted:

Mar 29, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fatty Liver

Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Mar 29, 2022