Clinical trial NCT05108415: Development and Validation of a Multi-target, Blood-based NAFLD Diagnosis Test
Official title: Blood Specimen Collection Study for NAFLD
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: NAFLD
NASH - Nonalcoholic Steatohepatitis
Lead sponsor: HBI Solutions Inc.
Sponsor class: INDUSTRY
Collaborators: name: mProbe Inc.
First posted: 2021-11-05
Enrollment: 1500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Confirmative of Number of Participants with NAFLD Diagnosis
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: