NAFLDNCT05108415
Development and Validation of a Multi-target, Blood-based NAFLD Diagnosis Test
An observational study of NAFLD and NASH - Nonalcoholic Steatohepatitis, run by HBI Solutions Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- NAFLD, NASH - Nonalcoholic Steatohepatitis
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- May 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- 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
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- 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
- 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
Who cannot join
- 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.
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- If female, known to be pregnant.
- COHORT B
- 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
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- NAFLD, NASH - Nonalcoholic Steatohepatitis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study startMay 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HBI Solutions Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- mProbe Inc.
- Responsible party
- Principal investigator, James Shilling, HBI Solutions Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108415
- Sponsor's protocol ID
- NAFLD_001
- Status last verified
- Mar 2023
- First submitted
- 25 Oct 2021
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Specimen Collection Study for NAFLD
- ClinicalTrials.gov ID
- NCT05108415
- Acronym / sponsor ID
- NAFLD_001
- Conditions
- NAFLD, NASH - Nonalcoholic Steatohepatitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- HBI Solutions Inc.Industry (pharma, biotech, devices)
- Collaborators
- mProbe Inc.
- Study start
- May 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Confirmative of Number of Participants with NAFLD Diagnosis
Time frame: 2 months
Confirmative of number of Participants with NAFLD diagnosis in patients undergoing routine screening ultrasonography, or post-ultrasonography.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of NAFLD and NASH - Nonalcoholic Steatohepatitis, run by HBI Solutions Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Schilling (6504279198, admin@mprobe.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmative of Number of Participants with NAFLD Diagnosis (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.