Clinical trial NCT05899309: Precision Medicine to Predict the Trajectory of Liver Cirrhosis: Prospective Cohort Study
Official title: Precision Medicine to Predict the Trajectory of Liver Cirrhosis : Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhosis
Metabolic Syndrome
Spleen; Fibrosis
Frailty
Keywords: liver cirrhosis
Metabolic syndrome
Cardiovascular events
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Aged 21 to 90 years with the diagnosis of liver cirrhosis (regardless of etiology)
* Consent to participate in the study

Exclusion Criteria:

* Terminal malignancy. Subjects with prognosis \< 3 months.
* Patient refusal or unable to commit to study follow-up

Primary outcomes:
measure: Liver related events
timeFrame: 3 years
Secondary outcomes:
measure: Progression of cirrhosis
timeFrame: 3 years
measure: Cardiovascular events
timeFrame: 3 years
measure: Baseline cirrhosis features
timeFrame: 3 years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital
name: Yu Jun Wong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Chang 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.