Precision Medicine to Predict the Trajectory of Liver Cirrhosis: Prospective Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Cirrhosis; Metabolic Syndrome; Frailty; Spleen; Fibrosis
• Intervention / Treatment: Diagnostic test: liver and spleen stiffness test and laboratory test

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 Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Seok Hwee Koo, PhD; Phone Number: 68504929; Email: seok_hwee_koo@cgh.com.sg
• Study Contact Backup: Name: Siew Yoon Yap, BSc; Phone Number: 68502935; Email: yap.siew.yoon@singhealth.com.sg

Study Locations

• Singapore
  • Singapore, Singapore, 529889
    • Recruiting
    • Changi General Hospital
    • Contact: Ann Cheung, MSc; Phone Number: 64267823; Email: ann.cheung.n.s@singhealth.com.sg
    • Contact: Siew Yoon Yap, BSc; Phone Number: 2935 68502935; Email: yap.siew.yoon@singhealth.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Liver cirrhosis with metabolic syndrome; Liver cirrhosis patients with metabolic syndrome on standard treatment	Diagnostic test: liver and spleen stiffness test and laboratory test; Diagnosis of cirrhosis can be based on liver biopsy,radiological ,clinical or liver stiffness measurement (LMS)
Liver cirrhosis without metabolic syndrome; Liver cirrhosis patients without metabolic syndrome on standard treatment	Diagnostic test: liver and spleen stiffness test and laboratory test; Diagnosis of cirrhosis can be based on liver biopsy,radiological ,clinical or liver stiffness measurement (LMS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver related events	Determine the rate of liver related events with and without metabolic syndrome	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression of cirrhosis	To determine the proportion of patients with cirrhosis progression (stage as defined by D' Amico method).	3 years
Cardiovascular events	Determine the rate of cardiovascular events with and without metabolic syndrome	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	3 years

Collaborators and Investigators

• Sponsor: Changi General Hospital
• Investigators: Principal Investigator: Yu Jun Wong, MD, Changi General Hospital

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2022
• Primary Completion (Estimated): December 12, 2023
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Metabolic syndrome; liver cirrhosis; Cardiovascular events
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Liver Diseases; Insulin Resistance; Hyperinsulinism; Fibrosis; Metabolic Syndrome; Liver Cirrhosis; Frailty
• Other Study ID Numbers: 2021/2815

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No