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

NCT ID: NCT05899309

Last Updated: 2023-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-23

Study Completion Date

2024-09-30

Brief Summary

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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

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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

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Liver Cirrhosis Metabolic Syndrome Spleen; Fibrosis Frailty

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Liver cirrhosis with metabolic syndrome

Liver cirrhosis patients with metabolic syndrome on standard treatment

liver and spleen stiffness test and laboratory test

Intervention Type DIAGNOSTIC_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

liver and spleen stiffness test and laboratory test

Intervention Type DIAGNOSTIC_TEST

Diagnosis of cirrhosis can be based on liver biopsy,radiological ,clinical or liver stiffness measurement (LMS)

Interventions

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liver and spleen stiffness test and laboratory test

Diagnosis of cirrhosis can be based on liver biopsy,radiological ,clinical or liver stiffness measurement (LMS)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changi General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yu Jun Wong, MD

Role: PRINCIPAL_INVESTIGATOR

Changi General Hospital

Locations

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Changi General Hospital

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Siew Yoon Yap, BSc

Role: CONTACT

Seok Hwee Koo, PhD

Role: CONTACT

Facility Contacts

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Ann Cheung, MSc

Role: primary

Siew Yoon Yap, BSc

Role: backup

68502935 ext. 2935

References

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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.

Reference Type BACKGROUND
PMID: 30983815 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26292950 (View on PubMed)

Other Identifiers

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2021/2815

Identifier Type: -

Identifier Source: org_study_id

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