Liver DiseasesNCT05457543
Blood Collection for Development and Validation of Point-of-Care Diagnostic Liver Function Tests
An observational study of Liver Diseases and Healthy, run by Group K Diagnostics Inc. at 1 site in United States.
Trial summary
This is an observational study exploring the performance of a novel point-of-care diagnostic testing platform designed to quantitate the presence of liver function biomarkers such as bilirubin. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Diseases, Healthy, Liver Cirrhosis
- What is being tested?
- Adult
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2022to Mar 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample
Who may be able to join
- 18 years of age and older
- Able to read and understand an informed consent form written in English
Who cannot join
- Pregnancy
- Participated in the present study within the last 6 days
- Subject is subjectively unwell at the time of enrollment visit
- Subject previously participated and has asked to be withdrawn from the study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Group K Diagnostics
Philadelphia, Pennsylvania, 19107
Laura M Ferguson, PhD, 484-633-7853, laura.ferguson@groupkdiagnostics.com
Brianna L Stevens, BSE, 609-699-3372, brianna@groupkdiagnostics.com
About this study
Official title: Collection of Blood Products for Use in the Development and Validation of Point-of-Care In Vitro Diagnostic Liver Function Test Devices
This is an observational study exploring the performance of a novel point-of-care diagnostic testing platform designed to quantitate the presence of liver function biomarkers such as bilirubin. Blood samples will be collected from participants to further development and validation of the testing platform to support FDA review. The diagnostic device is intended to provide rapid in-office test results using a finger stick of blood, a reaction test device, and a smartphone app.
Read the detailed description
The nature of outpatient diagnostics delays diagnosis and proper treatment due to the need to travel to a sample collection site that is designed for volume testing adding the individual's sample to the testing que. The physical and temporal separation of diagnostic testing from medical office or virtual care visits delays physician decision-making until results are available. Many patients even skip the recommended testing due to time and financial costs.
Many acute and chronic conditions result in disruption of normal liver function. Common prescription and over-the-counter medications also affect liver function when taken over extended periods or at elevated doses. Having multiple rapid, easy-to-use diagnostic tests on a single platform could improve condition diagnosis and medication monitoring by ensuring current test results are available every time and anywhere they could be useful for immediate medical decision-making.
This study will provide fresh blood samples for further development and validation of a novel point-of-care diagnostic testing platform. Tests for liver function biomarkers such as bilirubin, ALT (alanine transaminase), and AST (aspartate aminotransferase) will be characterized and validated using fresh whole blood, freshly prepared serum, and frozen serum. Enrolled participants will have a standard venous and a standard finger stick blood collection. Enrolled participants can return once weekly for blood draws or can chose to have only a single study visit. The study will continue until sufficient data has been generated to support review of the tests by the FDA.
- Conditions
- Liver Diseases, Healthy, Liver Cirrhosis, Liver Fibrosis
- Being tested
- Adult
- Keywords
- liver function, diagnostic test, point of care
- Medical subject headings
- Liver Diseases, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdultDiagnostic test
Investigational use of a novel liver function diagnostic test that involves a paper-based test device and a smartphone application.
| Study group | Role | What they receive |
|---|---|---|
| Adult | A venous blood and capillary blood collection is taken from each participant and tested with investigative diagnostic tests. Receives: Diagnostic Test: Adult |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regression analysis of bilirubin test results
Regression and other statistical analyses will be applied to bilirubin tests results to evaluate quantitation linearity, precision, and accuracy relative to a predicate device.
Measured: 6 months
Secondary outcomes (1)
Sensitivity of image analysis to changes in concentration of test analyte
Investigational device compositions will be evaluated for the resolution of colorimetric change as read by image analysis as the concentration of test analyte changes.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start30 Jun 2022
- Primary completionDec 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver DiseasesStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Group K Diagnostics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Laura M Ferguson, PhD, Group K Diagnostics Inc.
- Investigators
- Laura M Ferguson, PhD, Principal investigator, Group K Diagnostics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457543
- Sponsor's protocol ID
- GKD001
- Status last verified
- Jul 2022
- First submitted
- 11 Jul 2022
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
AuYoung B, Gutha Ravichandran A, Patel D, Dave N, Shah A, Wronko-Stevens B, Bettencourt F, Rajan R, Menon N. A Low-Cost Paper-Based Device for the Colorimetric Quantification of Bilirubin in Serum Using Smartphone Technology. Front Chem. 2022 Jul 7;10:869086. doi: 10.3389/fchem.2022.869086. eCollection 2022.
PubMed 35873049
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Blood Products for Use in the Development and Validation of Point-of-Care In Vitro Diagnostic Liver Function Test Devices
- ClinicalTrials.gov ID
- NCT05457543
- Acronym / sponsor ID
- GKD001
- Conditions
- Liver Diseases, Healthy, Liver Cirrhosis, Liver Fibrosis
- Keywords
- liver function, diagnostic test, point of care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Group K Diagnostics Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 14 Jul 2022 (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.
This is an observational study exploring the performance of a novel point-of-care diagnostic testing platform designed to quantitate the presence of liver function biomarkers such as bilirubin. Blood samples will be collected from participants to further development and validation of the testing platform to support FDA review. The diagnostic device is intended to provide rapid in-office test results using a finger stick of blood, a reaction test device, and a smartphone app.
Detailed description
The nature of outpatient diagnostics delays diagnosis and proper treatment due to the need to travel to a sample collection site that is designed for volume testing adding the individual's sample to the testing que. The physical and temporal separation of diagnostic testing from medical office or virtual care visits delays physician decision-making until results are available. Many patients even skip the recommended testing due to time and financial costs.
Many acute and chronic conditions result in disruption of normal liver function. Common prescription and over-the-counter medications also affect liver function when taken over extended periods or at elevated doses. Having multiple rapid, easy-to-use diagnostic tests on a single platform could improve condition diagnosis and medication monitoring by ensuring current test results are available every time and anywhere they could be useful for immediate medical decision-making.
This study will provide fresh blood samples for further development and validation of a novel point-of-care diagnostic testing platform. Tests for liver function biomarkers such as bilirubin, ALT (alanine transaminase), and AST (aspartate aminotransferase) will be characterized and validated using fresh whole blood, freshly prepared serum, and frozen serum. Enrolled participants will have a standard venous and a standard finger stick blood collection. Enrolled participants can return once weekly for blood draws or can chose to have only a single study visit. The study will continue until sufficient data has been generated to support review of the tests by the FDA.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult | – | Diagnostic Test: AdultA venous blood and capillary blood collection is taken from each participant and tested with investigative diagnostic tests. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (2 listed)
- 18 years of age and older
- Able to read and understand an informed consent form written in English
Key exclusion criteria (4 listed)
- Pregnancy
- Participated in the present study within the last 6 days
- Subject is subjectively unwell at the time of enrollment visit
- Subject previously participated and has asked to be withdrawn from 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdultInvestigational use of a novel liver function diagnostic test that involves a paper-based test device and a smartphone application. | Diagnostic test | Adult |
Primary outcome
Regression analysis of bilirubin test results
Time frame: 6 months
Regression and other statistical analyses will be applied to bilirubin tests results to evaluate quantitation linearity, precision, and accuracy relative to a predicate device.
1 secondary outcome
Sensitivity of image analysis to changes in concentration of test analyte
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Background: PubMed 35873049AuYoung B, Gutha Ravichandran A, Patel D, Dave N, Shah A, Wronko-Stevens B, Bettencourt F, Rajan R, Menon N. A Low-Cost Paper-Based Device for the Colorimetric Quantification of Bilirubin in Serum Using Smartphone Technology. Front Chem. 2022 Jul 7;10:869086. doi: 10.3389/fchem.2022.869086. eCollection 2022.
- Individual participant dataSharing planned: No
Related trials for Liver Diseases
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
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.
Laura M Ferguson, PhD principal investigator
Group K Diagnostics Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases and Healthy, run by Group K Diagnostics Inc. at 1 site in United States.
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 2 inclusion and 4 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 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Laura M Ferguson, PhD (484-633-7853, laura.ferguson@groupkdiagnostics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regression analysis of bilirubin test results (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05457543, which also lists 1 linked publication.
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 14 Jul 2022.