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Study of liver fibrosis using blood based tests and liver stiffness measurement

Diagnostic performance of FIB-4 , FIB -5 and APRI score for predicting liver fibrosis : A cross sectional study using Liver Stiffness Index as a reference - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/01/101442
Enrollment
150
Registered
2026-01-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: K740- Hepatic fibrosis

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil

Sponsors

Dr Karthik Chandra
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult greater than 18 years undergoing calculation of Liver Stiffness Index and have reports of Complete Blood Counts and Liver function tests within 3 months of calculation of Liver Stiffness Index

Exclusion criteria

Exclusion criteria: Participants will be excluded from the study if they meet any of the following conditions: 1. Acute Hepatic Injury 2. Pregnancy 3. Haematological Disorders Affecting Platelet Counts 4. Decompensated Cirrhosis 5. Severe Extrahepatic Illnesses 6. Recent Major Physiological Stressors

Design outcomes

Primary

MeasureTime frame
The primary outcome measure of this study is the diagnostic performance of existing non-invasive fibrosis scores namely FIB-4, APRI, and FIB-5 in predicting liver fibrosis as assessed by the Liver Stiffness Index (LSI) measured via transient elastography. AUROC (Area Under the Receiver Operating Characteristic Curve) for each score in identifying mild, moderate, and severe fibrosis grades. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of each fibrosis score compared to the Liver Stiffness Index. Distribution of fibrosis scores across different LSI strata to evaluate consistency of classification. Timepoint: 2 years

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr Karthik Chandra

Kasturba Medical College, Manipal

karthikchandra616@gmail.com9956270570

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026