Exploration of a Novel Prognostic Prediction Model for Liver Cirrhosis

NCT07031843 | Recruiting

• 1 other identifier: 2025-078
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The liver, a key organ for metabolism and synthesis, is involved in protein, fat, and carbohydrate metabolism, as well as energy production. Hepatic injury and functional decline can lead to metabolic abnormalities in these three major nutrients, as well as in vitamins and trace elements. Malnutrition, one of the most common complications in cirrhosis patients, has a broader impact than traditional complications like hepatic encephalopathy, esophageal variceal bleeding, refractory ascites, and spontaneous bacterial peritonitis. It is closely related to patient prognosis. Therefore, malnutrition should be considered as important as ascites and hepatic encephalopathy in diagnosis and treatment, and nutritional metabolism should be incorporated into prognostic prediction models or scoring systems for cirrhosis patients. Currently, the nutrition assessment of cirrhosis patients mostly uses relatively subjective methods such as scales and scores. There is no specific gold-standard diagnostic criterion for malnutrition in cirrhosis patients. Also, existing prognostic models for cirrhosis patients do not adequately consider the impact of nutritional factors on disease prognosis. Metabolomics technology can detect changes in the types and levels of nutritional metabolites in cirrhosis patients and analyze the differences in nutritional metabolites under various nutritional statuses and their relationship with the prognosis of cirrhosis patients. This helps objectively reveal the predictive value of nutrition metabolism for the prognosis of cirrhosis patients. However, metabolomics has been rarely used in nutrition assessment studies of cirrhosis patients and merits further research. This study will employ a prospective cohort study design to analyze the baseline nutritional status of patients with liver cirrhosis, investigate the impact of nutritional factors on long-term prognosis, and develop a prognostic prediction model for liver cirrhosis that incorporates nutritional parameters.

Conditions

Cirrhosis

Keywords

cirrhosis; disease prognosis model; metabolomics; nutritional assessment

Outcome Measures

Primary Outcomes (1)

• Death

  Death due to cirrhosis progression

  From February 2023 to December 2026

Secondary Outcomes (1)

• complication

  From February 2023 to December 2026

Study Arms (1)

patients with cirrhosis

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".

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with liver cirrhosis in accordance with the reference criteria of the Chinese Society of Hepatology's "Guidelines for the Diagnosis and Treatment of Liver Cirrhosis".

You may qualify if:

• Participants must meet all of the following criteria to be eligible for this study.
• Willingness and ability to sign the informed consent form.
• Male or female, aged 18 to 75 years.
• 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".
• An expected survival of over 3 months.
• Full civil competence.

You may not qualify if:

• Primary liver cancer diagnosis, or supporting evidence of elevated alpha-fetoprotein (AFP≥100μg/L) for \>3 months, or imaging evidence of hepatic cancer nodules.
• 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.
• Severe pulmonary, cardiac, diabetic, or genetic metabolic diseases.
• Psychiatric hospitalization, suicide attempts, or temporary disability due to mental illness in the past 5 years.
• Pregnant or breastfeeding women.
• Individuals deemed unsuitable by the investigator.

Sponsors & Collaborators

• Juan Kang: lead

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 401336, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• juan Kang, M.D.

  The Second Affiliated Hospital of Chongqing Medical University

  STUDY CHAIR

Central Study Contacts

juan Kang, M.D.

CONTACT

+8613996112052; 68368892@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 22, 2025
• Study Start: February 1, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

CN (1)