Liver CirrhosisNCT05899309
Precision Medicine to Predict the Trajectory of Liver Cirrhosis: Prospective Cohort Study
An observational study of Liver Cirrhosis and Metabolic Syndrome, run by Changi General Hospital at 1 site in Singapore.
Trial summary
Preventing decompensation is a key endpoint in the management of compensate cirrhosis patients. The known factors that increases the risk of decompensation include the presence of clinically significant portal hypertension (CSPH) and the control of primary etiology of cirrhosis. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Liver Cirrhosis, Metabolic Syndrome, Spleen; Fibrosis
- What is being tested?
- liver and spleen stiffness test and laboratory test
- How many people
- 80 participants
- Where
- 1 siteSingapore
- Study dates
- 23 May 2022to Sep 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Personalize risk stratification in an unmet need because compensated cirrhosis patients has heterogeneous risk of deterioration. With growing prevalence of obesity, there are more and more cirrhosis patients having metabolic syndrome. The impart of metabolic syndrome among cirrhosis patients remain unclear.
Who may be able to join
- Aged 21 to 90 years with the diagnosis of liver cirrhosis (regardless of etiology)
- Consent to participate in the study
Who cannot join
- Terminal malignancy. Subjects with prognosis < 3 months.
- Patient refusal or unable to commit to study follow-up
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Changi General Hospital
Singapore, 529889
Ann Cheung, MSc, 64267823, ann.cheung.n.s@singhealth.com.sg
Siew Yoon Yap, BSc, 68502935 ext. 2935, yap.siew.yoon@singhealth.com.sg
About this study
Official title: Precision Medicine to Predict the Trajectory of Liver Cirrhosis : Prospective Cohort Study
Preventing decompensation is a key endpoint in the management of compensate cirrhosis patients. The known factors that increases the risk of decompensation include the presence of clinically significant portal hypertension (CSPH) and the control of primary etiology of cirrhosis. Other factors which may influence the progression of cirrhosis included the presence of metabolic syndrome (diabetes mellitus and obesity), frailty, concomitant medications (statin, non-selective beta-blocker) were not well understood. Investigators aim to perform a pilot, observational study to study various baseline factors in relation to the clinical outcome of cirrhosis patients in a prospective follow up.
Read the detailed description
All patient who fulfilled eligibility criteria will be consented and recruited. The study will last up to 3 years or up to 7 assessment and 7 visits All subjects will be followed every 6 monthly for study outcome from recruitment, biosamples (blood,urine and stool), elastography, quality of life questionnaire and frialty assessment were done at baseline. Completion of Sit to stand , handgrip and 6 minute walking test at baseline and Visit 3.All visits will be follow up on study outcome (liver-related events ,metabolic related outcome and cardiovascular related outcomes.). During decompensation (decrease in liver function ) .Collection of research leftover blood,urine and stool samples if applicable.
- Conditions
- Liver Cirrhosis, Metabolic Syndrome, Spleen; Fibrosis, Frailty
- Being tested
- liver and spleen stiffness test and laboratory test
- Keywords
- liver cirrhosis, Metabolic syndrome, Cardiovascular events
- Medical subject headings
- Liver Cirrhosis, Metabolic Syndrome, Fibrosis, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liver and spleen stiffness test and laboratory testDiagnostic test
Diagnosis of cirrhosis can be based on liver biopsy,radiological ,clinical or liver stiffness measurement (LMS)
| Study group | Role | What they receive |
|---|---|---|
| Liver cirrhosis with metabolic syndrome | Liver cirrhosis patients with metabolic syndrome on standard treatment Receives: Diagnostic Test: liver and spleen stiffness test and laboratory test | |
| Liver cirrhosis without metabolic syndrome | Liver cirrhosis patients without metabolic syndrome on standard treatment Receives: Diagnostic Test: liver and spleen stiffness test and laboratory test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver related events
Determine the rate of liver related events with and without metabolic syndrome
Measured: 3 years
Secondary outcomes (3)
Progression of cirrhosis
To determine the proportion of patients with cirrhosis progression (stage as defined by D' Amico method).
Measured: 3 years
Cardiovascular events
Determine the rate of cardiovascular events with and without metabolic syndrome
Measured: 3 years
Baseline cirrhosis features
Baseline differences (clinical, immunological and metabolomic differences) and liver stiffness and spleen stiffness measured using vibration on controlled transient elastography (in kPa) between cirrhosis patients with and without metabolic syndrome
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start23 May 2022
- Primary completion12 Dec 2023 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies 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
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu Jun Wong, MD, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899309
- Sponsor's protocol ID
- 2021/2815
- Status last verified
- Jun 2023
- First submitted
- 24 May 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harris PS, Hansen RM, Gray ME, Massoud OI, McGuire BM, Shoreibah MG. Hepatocellular carcinoma surveillance: An evidence-based approach. World J Gastroenterol. 2019 Apr 7;25(13):1550-1559. doi: 10.3748/wjg.v25.i13.1550.
PubMed 30983815Chang PE, Wong GW, Li JW, Lui HF, Chow WC, Tan CK. Epidemiology and Clinical Evolution of Liver Cirrhosis in Singapore. Ann Acad Med Singap. 2015 Jun;44(6):218-25.
PubMed 26292950
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Medicine to Predict the Trajectory of Liver Cirrhosis : Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05899309
- Acronym / sponsor ID
- 2021/2815
- Conditions
- Liver Cirrhosis, Metabolic Syndrome, Spleen; Fibrosis, Frailty
- Keywords
- liver cirrhosis, Metabolic syndrome, Cardiovascular events
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- 23 May 2022 (actual)
- Primary completion
- 12 Dec 2023 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 12 Jun 2023 (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.
Preventing decompensation is a key endpoint in the management of compensate cirrhosis patients. The known factors that increases the risk of decompensation include the presence of clinically significant portal hypertension (CSPH) and the control of primary etiology of cirrhosis. Other factors which may influence the progression of cirrhosis included the presence of metabolic syndrome (diabetes mellitus and obesity), frailty, concomitant medications (statin, non-selective beta-blocker) were not well understood. Investigators aim to perform a pilot, observational study to study various baseline factors in relation to the clinical outcome of cirrhosis patients in a prospective follow up.
Detailed description
All patient who fulfilled eligibility criteria will be consented and recruited. The study will last up to 3 years or up to 7 assessment and 7 visits All subjects will be followed every 6 monthly for study outcome from recruitment, biosamples (blood,urine and stool), elastography, quality of life questionnaire and frialty assessment were done at baseline. Completion of Sit to stand , handgrip and 6 minute walking test at baseline and Visit 3.All visits will be follow up on study outcome (liver-related events ,metabolic related outcome and cardiovascular related outcomes.). During decompensation (decrease in liver function ) .Collection of research leftover blood,urine and stool samples if applicable.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liver cirrhosis with metabolic syndrome | – | Diagnostic Test: liver and spleen stiffness test and laboratory testLiver cirrhosis patients with metabolic syndrome on standard treatment |
| Liver cirrhosis without metabolic syndrome | – | Diagnostic Test: liver and spleen stiffness test and laboratory testLiver cirrhosis patients without metabolic syndrome on standard treatment |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Personalize risk stratification in an unmet need because compensated cirrhosis patients has heterogeneous risk of deterioration. With growing prevalence of obesity, there are more and more cirrhosis patients having metabolic syndrome. The impart of metabolic syndrome among cirrhosis patients remain unclear.
Key inclusion criteria (2 listed)
- Aged 21 to 90 years with the diagnosis of liver cirrhosis (regardless of etiology)
- Consent to participate in the study
Key exclusion criteria (2 listed)
- Terminal malignancy. Subjects with prognosis < 3 months.
- Patient refusal or unable to commit to study follow-up
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 |
|---|---|---|
| liver and spleen stiffness test and laboratory testDiagnosis of cirrhosis can be based on liver biopsy,radiological ,clinical or liver stiffness measurement (LMS) | Diagnostic test | Liver cirrhosis with metabolic syndrome, Liver cirrhosis without metabolic syndrome |
Primary outcome
Liver related events
Time frame: 3 years
Determine the rate of liver related events with and without metabolic syndrome
3 secondary outcomes
Progression of cirrhosis
Time frame: 3 years
Cardiovascular events
Time frame: 3 years
Baseline cirrhosis features
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Background: PubMed 30983815Harris PS, Hansen RM, Gray ME, Massoud OI, McGuire BM, Shoreibah MG. Hepatocellular carcinoma surveillance: An evidence-based approach. World J Gastroenterol. 2019 Apr 7;25(13):1550-1559. doi: 10.3748/wjg.v25.i13.1550.
- Background: PubMed 26292950Chang PE, Wong GW, Li JW, Lui HF, Chow WC, Tan CK. Epidemiology and Clinical Evolution of Liver Cirrhosis in Singapore. Ann Acad Med Singap. 2015 Jun;44(6):218-25.
- 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.
Yu Jun Wong, MD principal investigator
Changi General Hospital
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 Cirrhosis and Metabolic Syndrome, run by Changi General Hospital at 1 site in Singapore.
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 2 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 12 Jun 2023. 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 Singapore. 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 Siew Yoon Yap, BSc (68502935, yap.siew.yoon@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver related events (time frame: 3 years). 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 NCT05899309, which also lists 2 linked publications.
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 12 Jun 2023.