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Diagnostic Value of Golgi Protein 73 and Chitinase-3-Like Protein 1 Detection in Liver Fibrosis Staging

Clinical diagnostic significance of Golgi 73 protein and chitase protein in hepatic fibrosis stage

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600126689
Enrollment
Unknown
Registered
2026-06-13
Start date
2026-06-15
Completion date
Unknown
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Fibrosis

Interventions

Gold Standard:Liver biopsy results served as the standard
Index test:The core biomarkers, Golgi Protein 73 (GP73) and Chitinase-3-Like Protein 1 (CHI3L1), along with the four serum markers of liver fibrosis (Hyaluronic Acid [HA], Laminin [LN], Amino-Terminal

Sponsors

Yongchuan Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Hospitalized patients from the Department of Hepatobiliary Surgery and the Department of Infectious Diseases at The Affiliated Yongchuan Hospital Of Chongqing Medical University, who underwent liver biopsy and were ultimately diagnosed with liver fibrosis or cirrhosis.?; 2.The serum samples meet the requirements for collection and preservation (e.g., uncontaminated and sufficient volume); 3.Complete clinical information? (including case number, age, sex, diagnosis, and liver biopsy staging) is available; 4.Inclusion Criteria (General): Aged 18 to 75 years, regardless of gender; clear consciousness and ability to complete questionnaires cooperatively. Patient samples shall meet the requirements for collection and preservation, and all participants shall undergo imaging examinations. All participants shall voluntarily sign the informed consent form and commit to full follow-up throughout the study. (1) Liver fibrosis group: Blood tests showed mild abnormalities in liver function indicators (ALT, AST), without significant elevation of bilirubin; imaging examinations (Ultrasound/CT) revealed no signs of cirrhosis; liver biopsy confirmed F1-F3 stage, excluding F4 stage. (2) Cirrhosis group:?? Blood tests revealed decreased albumin levels and abnormal coagulation function; imaging studies (Ultrasound/MRI) showed signs of cirrhosis and portal hypertension; diagnosis was confirmed as F4 stage by liver biopsy or clinical assessment, with hepatocellular carcinoma (HCC) excluded. (3) Healthy control group: Blood tests showed normal liver function and coagulation parameters; imaging studies revealed no abnormalities in the liver parenchyma; no indications for liver biopsy, and no history of liver disease or factors for liver damage.??

Exclusion criteria

Exclusion criteria: 1. Restrictions on Underlying Diseases: Patients with severe failure of the heart, kidney, lung or other organs; those suffering from other malignant tumors (whether cured or not); and individuals with mental illnesses or cognitive disorders who are unable to comply with the research procedures. 2. Issues Regarding Data Integrity: Receipt of liver-related treatments (e.g., antiviral drugs, liver-protective medications) within the past month, which may interfere with the detection results of serum indicators; failure to provide complete medical history (such as history of liver fluke infection and biliary tract surgery) or refusal to cooperate with follow-up. 3. Ethics-related Requirements: Failure to sign the informed consent form; female participants who are pregnant or breastfeeding (due to potential radiation risks from imaging examinations). 4. Sample Collection Restrictions: Unclear sample collection time, incomplete clinical information or untraceable samples; samples failing to meet collection and preservation requirements (e.g., contamination during storage); insufficient sample volume for parallel testing; failure to obtain test results due to contamination or improper operation; samples deemed ineligible for testing by the researchers.

Design outcomes

Primary

MeasureTime frame
Submit 1-2 papers for publication;Submit 1-2 papers for publication;Area Under Curve, sensitivity, specificity, and optimal cut-off value;

Secondary

MeasureTime frame
Submit 1-2 papers for publication;Submit 1-2 papers for publication;Submit 1-2 papers for publication;Submit 1-2 papers for publication;

Countries

China

Contacts

Public ContactMo Zhan

Yongchuan Hospital of Chongqing Medical University

290874389@qq.com+86 23 8536 8263

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 21, 2026