Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202309644280965 Date of Approval: 21/09/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Fetuin-A, a Promising Serum Biomarker for Diagnosis of Non-Alcoholic Fatty Liver Disease (NAFLD)
Official scientific title Role of Fetuin-A, as a non-invasive Biomarker in Diagnosis and Assessment of severity of Non-Alcoholic Fatty Liver Disease (NAFLD)
Brief summary describing the background and objectives of the trial Non-alcoholic fatty liver disease (NAFLD) is rapidly becoming one of the most common causes of chronic liver disease worldwide. The biopsy is the gold standard tool for chronic liver disease diagnosis, but it is usually not accepted by patients due to its invasive nature. The use of non-invasive biomarkers is now attracting great interest in the diagnosis and detection of disease severity. The work aimed to investigate the role of fetuin-A in the diagnosis and assessment of the severity of non-alcoholic fatty liver disease (NAFLD).
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/12/2022
Actual trial start date 01/12/2022
Anticipated date of last follow up 31/12/2022
Actual Last follow-up date 31/12/2022
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Healthy group once 30 mint (US and Fibroscan ) 1-The cases were subjected to the following; history taking (including the demographic data and history of present illness) 2-The clinical/pathological data of patients were recorded, including age, sex, complete medical history. 3-clinical examination with stress on chronic fatigue, hypertension, manifestations suggesting chronic liver diseases due to viral or other non-viral causes (ascites, LL edema, jaundice, pruritus, Kayser–Fleischer rings (KF rings) by slit lamp examination, clubbing of fingers, signs of chest disease, signs of heart and renal failure) and hepatobiliary malignancy. 4- diagnosis of NAFLD was based on abdominal U/S and Fibroscan with CAP with or without elevated liver enzymes 5- Fibrosis score was calculated according to this formula: -1.675 + 0.037 × age (years) + 0.094 × BMI (kg/m2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio – 0.013 × platelet (×109/l) – 0.66 × albumin (g/dl) 50 Uncontrolled
Experimental Group NAFLD group once 30 m (US and Fibroscan ) 1-The cases were subjected to the following; history taking (including the demographic data and history of present illness) 2-The clinical/pathological data of patients were recorded, including age, sex, complete medical history. 3-clinical examination with stress on chronic fatigue, hypertension, manifestations suggesting chronic liver diseases due to viral or other non-viral causes (ascites, LL edema, jaundice, pruritus, Kayser–Fleischer rings (KF rings) by slit lamp examination, clubbing of fingers, signs of chest disease, signs of heart and renal failure) and hepatobiliary malignancy. 4- diagnosis of NAFLD was based on abdominal U/S and Fibroscan with CAP with or without elevated liver enzymes 5- Ultrasonography was performed using a 2-5 MHz convex transducer. Various (0-3) grades of steatosis have been proposed based on visual analysis of the intensity of the echogenicity, provided that the gain setting is optimum. When the echogenicity is just increased, it is grade I; when the echogenic liver obscures the echogenic walls of portal vein branches, it is grade II, and, when the echogenic liver obscures the diaphragmatic outline, it is grade III fatty infiltration 6- liver stiffness measurement (LSM) and CAP were obtained using FibroScan502 (Echosens, Paris, France). All subjects will be advised to fast for at least 8 hours before the procedure. The LSM score was represented by the median of 10 measurements and was considered reliable only if at least 10 successful acquisitions were obtained and the IQR-to-median ratio of the 10 acquisitions was ≤30%. CAP measurements were considered reliable and included in the final analysis if 10 successful acquisitions were obtained. Hepatic steatosis was graded by CAP using the M probe according to published cut-offs (S1=222–232; S2= 233–289 and S3 ≥290 dB/m) Fibrosis score was calculated according to this formula: -1.675 + 0.037 × age (years) + 0.094 × BMI (kg/m2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio – 0.013 × platelet (×109/l) – 0.66 × albumin (g/dl). 7- measurement of serum fetuin-A serum concentrations of fetuin-A was measured by using a human fetuin-A sandwich enzyme-linked immunosorbent assay (ELISA) kit. The inter-assay coefficient of variation is 5.2%, and the intra-assay coefficient of variant is 7.8%. 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.a dull or aching pain in the top right of the tummy (over the lower right side of the ribs) 2. extreme tiredness 3.unexplained weight loss 4.weakness 1.Patients below the age of 18. 2.patients with a history of significant alcohol intake exceeding 40 g/d in males and 20 g/d in females over the past 5 years. 3.presence of concomitant hepatitis B and hepatitis C virus infection. 4.patients with symptoms and signs suggesting (hemochromatosis, Wilson’s disease, alpha-one anti-trypsin deficiency and autoimmune hepatitis). 5.patients with hepatobiliary malignancy and pregnant females (unfit for Fibroscan & CAP). 6.Patients who use these medications; steatogenic drugs (amiodarone, valproic acid, antiretroviral drugs, methotrexate, and tetracyclines), or medicines that are used for the management of NAFLD (Vitamin E, metformin, and thiazolidinediones) . 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/08/2021 The Benha University Hospital Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Benha Univerity Benha 13518 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome diagnosis of NAFLD based on abdominal U/S and Fibroscan with CAP with or without elevated liver enzymes throughout the intervention
Secondary Outcome diagnosis of NAFLD with Fetuin-A biomarker assessment throughout the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Benha University Hospital Benha University Hospital Benha 13717 Egypt
Mahalla Liver Teaching Hospital El-Mahalla, Gharbia Provience, Egypt Mahalla 31951 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Amira Ahmed Othman Faculty of Medicine, Suez University, Suez, Egypt Suez 43511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Benha University Hospitals Benha Benha 13518 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amira Othman Amira.Othman@med.suezuni.edu.eg 00201003258097 Faculty of medicine, Suez University, Suez, Egypt
City Postal code Country Position/Affiliation
Suez 43511 Egypt Lecturer
Role Name Email Phone Street address
Public Enquiries Mohamed Elhoseeny mohamedM.elhoseeny@gmail.com 00201002719185 Benha
City Postal code Country Position/Affiliation
Benha 13518 Egypt Lecturer
Role Name Email Phone Street address
Scientific Enquiries Badawy Abdulaziz badayabdulaziz@gmail.com 00201021151536 Benha
City Postal code Country Position/Affiliation
Benha 13518 Egypt Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data Will be available, All of the individual participant data collected during the trial, after deidentification Statistical Analysis Plan Immediately following publication, No end date open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information