Exploring changes in metabolites related to liver cancer
A Bidirectional Study in Exploring the Dynamic Changes of Plasma and Urine Metabolites During the Occurrence and Development of Liver Cancer in Southern China
This study is trying to see how changes in certain substances in blood and urine can help identify liver cancer early in people with different liver diseases.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05719480 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the dynamic changes of plasma and urine metabolites in patients with various liver diseases, including hepatitis, cirrhosis, fatty liver, and liver cancer. It involves both retrospective and prospective cohorts, recruiting a total of 2000 participants to analyze how these metabolites change as liver diseases progress towards cancer. The study utilizes advanced proteomics technology and liquid biopsy methods to gather data without providing any treatment based on the study protocol. The goal is to identify potential biomarkers for early detection and diagnosis of liver cancer.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with hepatitis B, fatty liver disease, liver cirrhosis, or liver cancer, as well as healthy individuals for comparison.
Not a fit: Patients with non-research related liver diseases or other conditions affecting blood metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and diagnosis of liver cancer, potentially enhancing treatment outcomes.
How similar studies have performed: Other studies have explored metabolite changes in liver diseases, but this specific approach focusing on the dynamic changes leading to liver cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with hepatitis B: patients who meet the WS299-2008 Diagnostic Standards for Hepatitis B issued by the Ministry of Health. 2. Patients with fatty liver: patients whose liver imaging findings meet the imaging diagnostic criteria for diffuse fatty liver disease or whose liver biopsy histology changes meet the pathological diagnostic criteria for fatty liver disease. 3. Patients with liver cirrhosis: patients who meet the diagnostic criteria of the Guidelines for the Diagnosis and Treatment of Liver Cirrhosis (2019) issued by the Hepatology Branch of the Chinese Medical Association; 4. Liver cancer patients: patients who comply with the Diagnostic and Treatment Standards for Primary Liver Cancer (2019 Edition) issued by the National Health Commission of the People's Republic of China. Exclusion Criteria: - 1. People who have a history of non research related liver diseases or other diseases known to affect blood metabolism (except for controlled type II diabetes); 2. Have a history of other malignant tumors, except for fully treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ; 3. Diseases requiring long-term use of immunosuppressive drugs (including steroids), including but not limited to congenital or acquired immunodeficiency diseases or active central nervous system metastatic cancer, active infection or uncontrolled heart disease; 4. Suffer from other uncontrolled serious diseases at the same time, such as unstable heart disease requiring treatment, diabetes with unsatisfactory control (fasting blood glucose\>1.5 × Upper limit of normal value), mental illness and severe allergic history. 5. BMI is less than 18 or more than 25.
Where this trial is running
Guangzhou, Guangdong
- Southern medical university — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: jian guan, MD — Nanfang Hospital, Southern Medical University
- Study coordinator: jian guan, MD
- Email: guanjian5461@163.com
- Phone: 136 3210 2247
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.