Predicting liver deterioration and death in people with cirrhosis
Predictors of Decompensation, Acute-on-chronic Liver Failure and Mortality in Liver Cirrhosis - a Multicentre, Prospective, Observational Study From the SingHealth Chronic Liver Disease Registry (SoLiDaRity-DAM)
Singapore General Hospital · NCT07438288
This project will try to identify clinical signs and lab or imaging markers that predict worsening, acute-on-chronic liver failure (ACLF), or death in adults with cirrhosis treated at Singapore hospitals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Singapore General Hospital (other) |
| Locations | 3 sites (Singapore and 2 other locations) |
| Trial ID | NCT07438288 on ClinicalTrials.gov |
What this trial studies
This is a prospective, non-interventional observational registry that will collect and analyze clinical data from hospital records of adults with cirrhosis seen at three Singapore hospitals. Investigators will track 1-, 3-, and 5-year risks of decompensation, ACLF, and death and record specific liver-related complications and candidate biomarkers. The study will test and externally validate existing predictive scores (ALBI, CHESS-ALARM, LSPS, PREDICT) and examine how different disease causes influence outcomes. It will also act as a core hub for future ancillary studies on diagnosis, prognosis, and pathogenesis of acute decompensation and ACLF.
Who should consider this trial
Good fit: Adults aged 18 and over with a clinical diagnosis of liver cirrhosis who receive care at the participating Singapore hospitals and are willing to give informed consent are ideal candidates.
Not a fit: People without clinical cirrhosis or those who do not consent will not be eligible, and participants should understand that because the study is observational they may not receive any direct treatment benefit.
Why it matters
Potential benefit: If successful, clinicians could identify high-risk patients earlier and target interventions to prevent or delay complications like decompensation, ACLF, and death.
How similar studies have performed: Previous research using clinical predictors and scoring systems has shown promise and some models (for example ALBI and PREDICT) have been externally validated, though prospective hub registries for ACLF prediction are relatively limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with clinical diagnosis of liver cirrhosis 2. Age 18 years and above (parental consent required if below 21 years) 3. Willing and able to provide informed consent Exclusion Criteria: * No clinical evidence of liver cirrhosis * Not willing to provide informed consent
Where this trial is running
Singapore and 2 other locations
- Changi General Hospital — Singapore, Singapore (RECRUITING)
- Sengkang General Hospital — Singapore, Singapore (RECRUITING)
- Singapore General Hospital — Singapore, Singapore (RECRUITING)
Study contacts
- Study coordinator: Jason Pik Eu Chang, MBBS, MRCP
- Email: jason.chang@singhealth.com.sg
- Phone: +65 6321 4684
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cirrhosis and Chronic Liver Disease, Cirrhosis, Decompensation, Acute-on-chronic liver failure, Death