CirrhosisNCT07031843
Exploration of a Novel Prognostic Prediction Model for Liver Cirrhosis
An observational study of Cirrhosis, run by Juan Kang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhosis
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 30 Dec 2026
- How long will I take part?
- 3 Years
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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".
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 401336
1809366436, 2023120784@stu.cqmu.edu.cn
About this study
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.
Read the detailed description
Patients with cirrhosis attending the Second Affiliated Hospital of Chongqing Medical University were included in this prospective study. Eligible subjects were determined based on the inclusion and exclusion criteria. Clinical data were collected, including gender, age, blood routine, liver and kidney function, coagulation function, comorbidities, complications, and disease progression. Various indicators were calculated, including body mass index (BMI), Prognostic Nutritional Index (PNI), Geriatric Nutritional Risk Index (GNRI), Model for End-Stage Liver Disease (MELD) score, MELD-Na score, and MELD 3.0 score. Nutritional risk screening and malnutrition assessment were also performed. Resting energy expenditure was measured by professionals, and blood samples were collected for non-targeted nutritional metabolite profiling. Patients were followed up at 3 months, 6 months, 1 year, and 2 years to assess survival status, hepatic adverse events, and complication occurrence. Statistical analysis was conducted to identify nutritional scores, indicators, or differential metabolite levels closely associated with patient prognosis. Variables for model construction and scoring were determined, assigned scores, and a novel prognostic prediction model for cirrhosis patients was developed and optimized. This study aims to integrate nutritional assessment into the prognostic evaluation system for cirrhosis patients, establishing a more objective, accurate, and comprehensive model. It provides evidence for nutritional intervention and improving patient prognosis and lays a foundation for further research. Additionally, metabolomics analysis of differential metabolites in cirrhosis patients with varying nutritional statuses and prognoses offers insights into the molecular mechanisms of nutritional metabolism's impact on prognosis.
- Conditions
- Cirrhosis
- Keywords
- cirrhosis, disease prognosis model, metabolomics, nutritional assessment
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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". |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Death due to cirrhosis progression
Measured: From February 2023 to December 2026
Secondary outcomes (1)
complication
complication such as infection，ascites
Measured: From February 2023 to December 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Feb 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Juan Kang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan Kang, The Second Affiliated Hospital of Chongqing Medical University
- Investigators
- juan Kang, M.D., Study chair, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031843
- Sponsor's protocol ID
- 2025-078
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of a Novel Prognostic Prediction Model for Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT07031843
- Acronym / sponsor ID
- 2025-078
- Conditions
- Cirrhosis
- Keywords
- cirrhosis, disease prognosis model, metabolomics, nutritional assessment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Juan KangUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 22 Jun 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.
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.
Detailed description
Patients with cirrhosis attending the Second Affiliated Hospital of Chongqing Medical University were included in this prospective study. Eligible subjects were determined based on the inclusion and exclusion criteria. Clinical data were collected, including gender, age, blood routine, liver and kidney function, coagulation function, comorbidities, complications, and disease progression. Various indicators were calculated, including body mass index (BMI), Prognostic Nutritional Index (PNI), Geriatric Nutritional Risk Index (GNRI), Model for End-Stage Liver Disease (MELD) score, MELD-Na score, and MELD 3.0 score. Nutritional risk screening and malnutrition assessment were also performed. Resting energy expenditure was measured by professionals, and blood samples were collected for non-targeted nutritional metabolite profiling. Patients were followed up at 3 months, 6 months, 1 year, and 2 years to assess survival status, hepatic adverse events, and complication occurrence. Statistical analysis was conducted to identify nutritional scores, indicators, or differential metabolite levels closely associated with patient prognosis. Variables for model construction and scoring were determined, assigned scores, and a novel prognostic prediction model for cirrhosis patients was developed and optimized. This study aims to integrate nutritional assessment into the prognostic evaluation system for cirrhosis patients, establishing a more objective, accurate, and comprehensive model. It provides evidence for nutritional intervention and improving patient prognosis and lays a foundation for further research. Additionally, metabolomics analysis of differential metabolites in cirrhosis patients with varying nutritional statuses and prognoses offers insights into the molecular mechanisms of nutritional metabolism's impact on prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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". |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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".
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death
Time frame: From February 2023 to December 2026
Death due to cirrhosis progression
1 secondary outcome
complication
Time frame: From February 2023 to December 2026
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 22 Jun 2025.
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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.
juan Kang, M.D. study chair
The Second Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis, run by Juan Kang at 1 site in China.
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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 juan Kang, M.D. (+8613996112052, 68368892@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: From February 2023 to December 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2025.