| CTRI Number |
CTRI/2026/01/101442 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
17/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of liver fibrosis using blood based tests and liver stiffness measurement |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Karthik Chandra |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine
Kasturba Medical College
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9956270570 |
| Fax |
|
| Email |
karthikchandra616@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karthik Chandra |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine
Kasturba Medical College
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9956270570 |
| Fax |
|
| Email |
karthikchandra616@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karthik Chandra |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine
Kasturba Medical College
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9956270570 |
| Fax |
|
| Email |
karthikchandra616@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Karthik Chandra |
| Address |
Department of General Medicine
Kasturba Hospital
Manipal
576104 |
| Type of Sponsor |
Other [Self sponsored] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Adarsha G K |
Kasturba Hospital, Manipal |
Room number 12
Faculty Room
OPD Block
Department of General Medicine
Udupi
KARNATAKA |
9591706468
adarsha.gk@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K740||Hepatic fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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.
|
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="11" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective cross-sectional observational study conducted in adult patients undergoing liver stiffness assessment as part of routine clinical evaluation. The study aims to assess and compare the diagnostic performance of commonly used non-invasive liver fibrosis scores, namely FIB-4, APRI, and FIB-5, using the Liver Stiffness Index as the reference standard. Relevant clinical details and laboratory parameters will be obtained from existing medical records, without performing any additional investigations or interventions. The diagnostic accuracy of each score will be evaluated using receiver operating characteristic (ROC) curve analysis, along with sensitivity, specificity, and related performance measures. |