A prognostic model that adds nutritional and metabolic measures for liver cirrhosis
Official title: Exploration of a Novel Prognostic Prediction Model for Liver Cirrhosis
Run by The Second Affiliated Hospital of Chongqing Medical University · NCT07031843 · Data updated 2026-11-12
This project will test whether adding objective nutritional measurements and metabolic profiles to routine clinical data can better predict outcomes for adults with liver cirrhosis.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | The Second Affiliated Hospital of Chongqing Medical University Academic / other |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Status | Recruiting |
| Started | February 1, 2023 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | June 22, 2025 |
| Trial ID | NCT07031843 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to 75 with a clinical diagnosis of liver cirrhosis, expected survival over three months, and capacity to consent and attend follow-up visits are ideal candidates.
✕Probably not a fit
Patients with active primary liver cancer, recent other malignancies, severe cardiopulmonary or genetic metabolic diseases, or those unable to complete follow-up are unlikely to benefit from this project.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational cohort of adults with cirrhosis enrolled at the Second Affiliated Hospital of Chongqing Medical University. Researchers will collect clinical data, standard liver and renal labs, nutritional scores (BMI, PNI, GNRI), resting energy expenditure, and non-targeted blood metabolomics. Patients will be followed at 3 months, 6 months, 1 year, and 2 years to record survival, hepatic events, and complications. Statistical analyses will identify nutrition- and metabolite-based variables to build and optimize a novel prognostic scoring model for cirrhosis.
Why it matters
Potential benefit: If successful, the model could give patients more accurate prognoses and support earlier, targeted nutritional care that may reduce complications and improve outcomes.
How similar studies have gone: Previous studies have shown malnutrition predicts poorer outcomes in cirrhosis and metabolomics is an emerging approach with some promising but not yet widely validated prognostic results.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Participants must meet all of the following criteria to be eligible for this study. 1. Willingness and ability to sign the informed consent form. 2. Male or female, aged 18 to 75 years. 3. A diagnosis of liver cirrhosis that meets the reference criteria of the Chinese Society of Hepatology's "Guidelines for the Diagnosis and Treatment of Liver Cirrhosis". 4. An expected survival of over 3 months. 5. Full civil competence. Exclusion Criteria: 1. Primary liver cancer diagnosis, or supporting evidence of elevated alpha-fetoprotein (AFP≥100μg/L) for \>3 months, or imaging evidence of hepatic cancer nodules. 2. Malignancy history within 5 years before screening, except for specific cured cancers (e.g., basal cell skin cancer); current or past major illnesses (as defined by the China Insurance Regulatory Commission's 25 critical illnesses) that may affect treatment, assessment, or compliance. 3. Severe pulmonary, cardiac, diabetic, or genetic metabolic diseases. 4. Psychiatric hospitalization, suicide attempts, or temporary disability due to mental illness in the past 5 years. 5. Pregnant or breastfeeding women. 6. Individuals deemed unsuitable by the investigator.
Where it's running
-
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China Recruiting
Study contacts
- Study coordinator: juan Kang, M.D.
- Email: 68368892@qq.com
- Phone: +8613996112052
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.