Skip to content

Study on the value of a new biological marker urinary IGFBP7 in diagnosing the degree of the liver fibrosis in patients with chronic viral hepatitis B

Study on the value of a new biological marker urinary IGFBP7 in diagnosing the degree of the liver fibrosis in patients with chronic viral hepatitis B

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100045139
Enrollment
Unknown
Registered
2021-04-07
Start date
2021-04-01
Completion date
Unknown
Last updated
2021-11-08

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.
Index test:FibroTouch, LSM.

Sponsors

The Affiliated Hospital of Guangdong Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Aged >= 18 years; 2.Diagnosis of chronic viral hepatitis B.

Exclusion criteria

Exclusion criteria: 1.Exclude situations that may affect the accuracy of liver stiffness value (FSM): that is, any of the following situations cannot be included: (1) ALT >= 5 x ULN (5 times the upper limit of normal); (2) Total bilirubin >= 17.1µmol/L; (3) BMI > 30kg/m2; (4) Extrahepatic cholestasis (B-ultrasound indicates extrahepatic bile duct dilation and serum ALP >= 1.5 x ULN and GGT >= 3 x ULN); (5) Excessive alcohol intake (drinking alcohol 1 week before the examination); 2.Acute kidney injury (may affect urinary IGFBP7 concentration); 3.Pregnancy; 4.A history of alcohol or narcotic drug abuse, drug use, or a history of mental illness (such as schizophrenia, obsessive-compulsive disorder, depression), confrontational personality, bad motivation, suspiciousness or other emotional or intellectual problems, etc. may affect the knowledge of participating in this research Effectiveness; 5.Patients who cannot cooperate with the relevant inspections of this project and do not agree to sign an informed consent form; 6.The required information is incomplete.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;Accuracy;Area under the curve, AUC;

Countries

China

Contacts

Public ContactHan Huanqin

The Affiliated Hospital of Guangdong Medical University

huanqinhan@126.com+86 13828291023

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026