Liver CirrhosisNCT07238543
Comparative Study of Novel Prognostic Scores in Patients With Liver Cirrhosis
An observational study of Liver Cirrhosis, run by Assiut University.
Trial summary
1. To determine the prognostic performance of novel scores in predicting complications and in-hospital mortality in patients with liver cirrhosis. 2. To compare the accuracy of these scores in identifying high risk patients relative to the standard scores. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Usage of new scores
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study based on patients with Liver Cirrhosis
Who may be able to join
- • Age ≥ 18 years
- Diagnosis of liver cirrhosis (clinical, radiological using ultrasound or fibroscan)
- Hospital admission for acute decompensation (ascites, hepatic encephalopathy, variceal bleeding, SBP)
Who cannot join
- Pregnancy
- Refusal to participate in the study riteria:
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Study of Novel Prognostic Scores for Prediction of Morbidity and Mortality in Patients With Liver Cirrhosis
- To determine the prognostic performance of novel scores in predicting complications and in-hospital mortality in patients with liver cirrhosis.
- To compare the accuracy of these scores in identifying high risk patients relative to the standard scores.
Read the detailed description
- Liver cirrhosis represents the end stage of chronic liver diseases and remains a major global health burden, accounting for over 1 million deaths annually.
- It is characterized by progressive fibrosis, nodular regeneration, and architectural distortion of the liver parenchyma, ultimately leading to liver dysfunction and portal hypertension
- Once acute decompensation occurs the prognosis significantly worsens, with a sharp increase in short-term mortality
- Accurate outcome prediction in cirrhotic patients is essential for guiding early interventions, allocating healthcare resources, and prioritizing liver transplant listing.
- Traditional prognostic scores, such as the Child-Turcotte Pugh (CTP) and Model for End-Stage Liver Disease (MELD), have important limitations.
- CTP includes subjective variables, while MELD may not fully reflect clinical deterioration in early decompensation
- MELD is widely used to predict the short-term mortality in patients with cirrhosis, but potential limitations of this score have been reported.
- An integrated MELD model (iMELD) including serum sodium and age improves the prediction of early mortality in patients with cirrhosis The Chronic Liver Failure Consortium Acute Decompensation (CLIF-C AD) score, introduced by European Association for the Study of the Liver (EASL), was specifically designed for hospitalized patients with acute decompensation (without Faculty of Medicine Institutional Review Board (IRB) Assiut Medical School Research Proposal Form 3 ACLF). It incorporates age, white blood cell count, and organ function to better stratify risk
- Recently, newer prognostic models such as the ADRECIA score have been developed, incorporating variables such as inflammatory markers and kidney function. These models aim to further refine risk stratification in cirrhosis, especially in early decompensation, before organ failure sets in
- Although these novel scores show promise in identifying patients at high risk for deterioration or death, direct comparisons in real-world clinical settings are lacking.
- Understanding their relative performance could help optimize the management of hospitalized patients with AD cirrhosis, thereby facilitating early clinical decision-making, optimizing patient outcomes, and potentially improving resource allocation in hepatology care settings.
- Conditions
- Liver Cirrhosis
- Being tested
- Usage of new scores
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usage of new scoresOther
usage of new scores for prediction of morbidity and mortality in patients with liver cirrhosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative study of novel prognostic scores for prediction of morbidity and mortality in patients with liver cirrhosis
Usage of new prognostic scores for prediction of morbidity and mortality in patients with LC
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completionJan 2027 (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.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Hany Youssef Mina, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238543
- Sponsor's protocol ID
- New scores in liver cirrhosis
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jalan R, Saliba F, Pavesi M, Amoros A, Moreau R, Gines P, Levesque E, Durand F, Angeli P, Caraceni P, Hopf C, Alessandria C, Rodriguez E, Solis-Munoz P, Laleman W, Trebicka J, Zeuzem S, Gustot T, Mookerjee R, Elkrief L, Soriano G, Cordoba J, Morando F, Gerbes A, Agarwal B, Samuel D, Bernardi M, Arroyo V; CANONIC study investigators of the EASL-CLIF Consortium. Development and validation of a prognostic score to predict mortality in patients with acute-on-chronic liver failure. J Hepatol. 2014 Nov;61(5):1038-47. doi: 10.1016/j.jhep.2014.06.012. Epub 2014 Jun 17.
PubMed 24950482Asrani SK, Devarbhavi H, Eaton J, Kamath PS. Burden of liver diseases in the world. J Hepatol. 2019 Jan;70(1):151-171. doi: 10.1016/j.jhep.2018.09.014. Epub 2018 Sep 26.
PubMed 30266282
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Novel Prognostic Scores for Prediction of Morbidity and Mortality in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT07238543
- Acronym / sponsor ID
- New scores in liver cirrhosis
- Conditions
- Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 20 Nov 2025 (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.
- To determine the prognostic performance of novel scores in predicting complications and in-hospital mortality in patients with liver cirrhosis.
- To compare the accuracy of these scores in identifying high risk patients relative to the standard scores.
Detailed description
- Liver cirrhosis represents the end stage of chronic liver diseases and remains a major global health burden, accounting for over 1 million deaths annually.
- It is characterized by progressive fibrosis, nodular regeneration, and architectural distortion of the liver parenchyma, ultimately leading to liver dysfunction and portal hypertension
- Once acute decompensation occurs the prognosis significantly worsens, with a sharp increase in short-term mortality
- Accurate outcome prediction in cirrhotic patients is essential for guiding early interventions, allocating healthcare resources, and prioritizing liver transplant listing.
- Traditional prognostic scores, such as the Child-Turcotte Pugh (CTP) and Model for End-Stage Liver Disease (MELD), have important limitations.
- CTP includes subjective variables, while MELD may not fully reflect clinical deterioration in early decompensation
- MELD is widely used to predict the short-term mortality in patients with cirrhosis, but potential limitations of this score have been reported.
- An integrated MELD model (iMELD) including serum sodium and age improves the prediction of early mortality in patients with cirrhosis The Chronic Liver Failure Consortium Acute Decompensation (CLIF-C AD) score, introduced by European Association for the Study of the Liver (EASL), was specifically designed for hospitalized patients with acute decompensation (without Faculty of Medicine Institutional Review Board (IRB) Assiut Medical School Research Proposal Form 3 ACLF). It incorporates age, white blood cell count, and organ function to better stratify risk
- Recently, newer prognostic models such as the ADRECIA score have been developed, incorporating variables such as inflammatory markers and kidney function. These models aim to further refine risk stratification in cirrhosis, especially in early decompensation, before organ failure sets in
- Although these novel scores show promise in identifying patients at high risk for deterioration or death, direct comparisons in real-world clinical settings are lacking.
- Understanding their relative performance could help optimize the management of hospitalized patients with AD cirrhosis, thereby facilitating early clinical decision-making, optimizing patient outcomes, and potentially improving resource allocation in hepatology care settings.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study based on patients with Liver Cirrhosis
Key inclusion criteria (3 listed)
- • Age ≥ 18 years
Key exclusion criteria (2 listed)
- Pregnancy
- Refusal to participate in the study riteria:
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 |
|---|---|---|
| Usage of new scoresusage of new scores for prediction of morbidity and mortality in patients with liver cirrhosis | Other | – |
Primary outcome
Comparative study of novel prognostic scores for prediction of morbidity and mortality in patients with liver cirrhosis
Time frame: baseline
Usage of new prognostic scores for prediction of morbidity and mortality in patients with LC
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Results publication: PubMed 24950482Jalan R, Saliba F, Pavesi M, Amoros A, Moreau R, Gines P, Levesque E, Durand F, Angeli P, Caraceni P, Hopf C, Alessandria C, Rodriguez E, Solis-Munoz P, Laleman W, Trebicka J, Zeuzem S, Gustot T, Mookerjee R, Elkrief L, Soriano G, Cordoba J, Morando F, Gerbes A, Agarwal B, Samuel D, Bernardi M, Arroyo V; CANONIC study investigators of the EASL-CLIF Consortium. Development and validation of a prognostic score to predict mortality in patients with acute-on-chronic liver failure. J Hepatol. 2014 Nov;61(5):1038-47. doi: 10.1016/j.jhep.2014.06.012. Epub 2014 Jun 17.
- Results publication: PubMed 30266282Asrani SK, Devarbhavi H, Eaton J, Kamath PS. Burden of liver diseases in the world. J Hepatol. 2019 Jan;70(1):151-171. doi: 10.1016/j.jhep.2018.09.014. Epub 2018 Sep 26.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by Assiut University.
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 3 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: opening soon, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew hany Mina, Bachelor of Medicine (+201149072475, androwhany988@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparative study of novel prognostic scores for prediction of morbidity and mortality in patients with liver cirrhosis (time frame: baseline). 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 NCT07238543, 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 20 Nov 2025.