Cirrhosis, LiverNCT05538962
Longitudinal Monitoring of Inflammation in Cirrhosis
A study testing Sensor skin in people with Cirrhosis, Liver, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.
Trial summary
Longitudinal monitoring of inflammation using skin devices may help predict outcomes compared to traditional blood draws Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cirrhosis, Liver
- What is being tested?
- Sensor skin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 31 Jul 2024
- Phase
- Interventional
- 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
Who may be able to join
- Age >18 years
- Able to give consent
- Age >18 years
- Able to give consent
- Cirrhosis defined by any one of the following
- Cirrhosis on liver biopsy or transient wave elastography
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- Nodular liver on imaging
- Endoscopic or radiological evidence of varices in a patient with chronic liver disease
- Platelet count <150,000/mm3 and AST/ALT ratio >1 in a patient with chronic liver disease
- Patients with frank decompensation (ascites, HE, variceal bleeding, hepato-pulmonary syndrome)
- Age >18 years
- Able to give consent
- Cirrhosis defined by any one of the following
- Cirrhosis on liver biopsy or transient wave elastography
- Nodular liver on imaging
- Endoscopic or radiological evidence of varices in a patient with chronic liver disease
- Platelet count <150,000/mm3 and AST/ALT ratio >1 in a patient with chronic liver disease
- Patients with frank decompensation (ascites, HE, variceal bleeding, hepato-pulmonary syndrome)
Who cannot join
- Unable/unwilling to consent
- Chronic diseases
- Unable to come in daily or be available daily for 3 days.
- Outpatients with Cirrhosis:
- Unable/unwilling to consent
- Unclear diagnosis of cirrhosis
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- Unable to come in daily or be available daily for 3 days.
- Inflammatory bowel disease or other diseases that require immunosuppressive therapy use
- Inpatients with Cirrhosis:
- Unable/unwilling to consent
- Unclear diagnosis of cirrhosis
- Unable to be seen daily or able to come in daily for 3 days (if discharged in between)
- Inflammatory bowel disease or other diseases that require immunosuppressive therapy use
Trial locations and contacts
1 site in 1 country.
United States1 site
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
About this study
Longitudinal monitoring of inflammation using skin devices may help predict outcomes compared to traditional blood draws
- Conditions
- Cirrhosis, Liver
- Being tested
- Sensor skin
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensor skinDiagnostic test
Skin sensor to detect inflammatory molecules in sweat
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Experimental | Healthy controls will receive the sensors Receives: Diagnostic Test: Sensor skin |
| Outpatients with cirrhosis | Experimental | Outpatients with cirrhosis will receive the sensors Receives: Diagnostic Test: Sensor skin |
| Inpatients with cirrhosis | Experimental | Inpatients with cirrhosis will receive the sensors Receives: Diagnostic Test: Sensor skin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
We will study whether subjects have any issues or adverse events related to the sensor
Measured: 3 days
Secondary outcomes (4)
Ability to detect inflammatory markers (TNF, IL-1b, IL-6 and CRP) using skin sensor compared to blood values
Comparison of skin sensor data to blood inflammatory markers as above using daily blood draw and sensor values. Blood markers and sensor markers will be correlated for each day.
Measured: 3 days
Linkage of skin inflammatory markers (TNF, IL-6, IL-1b and CRP) with quality of life
Correlation of inflammatory markers using the skin sensor data to quality of life using Sickness Impact Profile and PROMIS questionnaires.
Measured: 3 days
Linkage of inflammatory markers (TNF, IL-6, IL-1b and CRP) with cognitive testing
Correlation of inflammatory markers using the skin sensor data to cognitive performance on PHES and EncephalApp Stroop
Measured: 3 days
Linkage of inflammatory markers with MELD score
Correlation of inflammatory markers using the skin sensor data to MELD score
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start1 Sep 2022
- Primary completion1 Sep 2023
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis, LiverStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All subjects will receive the sensor but they are 3 different populations, which is why there are 3 different arms
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jasmohan Bajaj, MD, Principal investigator, Hunter Holmes McGuire VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538962
- Sponsor's protocol ID
- BAJAJ0028
- Status last verified
- Jul 2024
- First submitted
- 7 Sep 2022
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Monitoring of Inflammation in Cirrhosis
- ClinicalTrials.gov ID
- NCT05538962
- Acronym / sponsor ID
- BAJAJ0028
- Conditions
- Cirrhosis, Liver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical CenterUS federal agency
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 14 Sep 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.
Longitudinal monitoring of inflammation using skin devices may help predict outcomes compared to traditional blood draws
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All subjects will receive the sensor but they are 3 different populations, which is why there are 3 different arms
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | Experimental | Diagnostic Test: Sensor skinHealthy controls will receive the sensors |
| Outpatients with cirrhosis | Experimental | Diagnostic Test: Sensor skinOutpatients with cirrhosis will receive the sensors |
| Inpatients with cirrhosis | Experimental | Diagnostic Test: Sensor skinInpatients with cirrhosis will receive the sensors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age >18 years
- Able to give consent
- Age >18 years
- Able to give consent
- Cirrhosis defined by any one of the following
Key exclusion criteria (13 listed)
- Unable/unwilling to consent
- Chronic diseases
- Unable to come in daily or be available daily for 3 days.
- Unable/unwilling to consent
- Unclear diagnosis of cirrhosis
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 |
|---|---|---|
| Sensor skinSkin sensor to detect inflammatory molecules in sweat | Diagnostic test | Healthy controls, Inpatients with cirrhosis, Outpatients with cirrhosis |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 3 days
We will study whether subjects have any issues or adverse events related to the sensor
4 secondary outcomes
Ability to detect inflammatory markers (TNF, IL-1b, IL-6 and CRP) using skin sensor compared to blood values
Time frame: 3 days
Linkage of skin inflammatory markers (TNF, IL-6, IL-1b and CRP) with quality of life
Time frame: 3 days
Linkage of inflammatory markers (TNF, IL-6, IL-1b and CRP) with cognitive testing
Time frame: 3 days
Linkage of inflammatory markers with MELD score
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Jasmohan Bajaj, MD principal investigator
Hunter Holmes McGuire VAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensor skin in people with Cirrhosis, Liver, run by Hunter Holmes Mcguire Veteran Affairs Medical Center 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 18 inclusion and 13 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: finished, as of the sponsor's last update on 2 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: 3 days). 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 2 Aug 2024.