Ignite Creation Date:
2024-07-17 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492369
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-12
Brief Title:
MAFLD Fibrosis Score for Detecting Fibrotic NASH in MAFLD Egyptian Patients
Sponsor:
Tanta University
Organization:
Tanta University
Study Overview
Official Title:
The Accuracy of MAFLD Fibrosis Score in Detecting Fibrotic NASH in MAFLD Egyptian Patients
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Metabolic-associated fatty liver disease MAFLD is a metabolic stress-induced liver injury characterized by diffuse hepatocyte macrovesicular fatty infiltration
The incidence of MAFLD is increasing yearly and its incidence rate is as high as 20 to 30 on a global scale which seriously affects peoples health Non-alcoholic steatohepatitis NASH a chronic hepatitis that can progress to advanced fibrosis decompensated cirrhosis and hepatocellular carcinoma affects one-fifth of NAFLD patients Depending on the histological severity of fibrosis patients with NASH can be further classified as early NASH F0-F1 fibrosis fibrotic NASH F2 fibrosis or NASH-cirrhosis F4 fibrosis
Identifying subjects with fibrotic NASH is essential as they are at risk of complications and disease progression and may benefit from potential pharmacological therapy
Assessment of fibrotic NASH ranges from noninvasive scores to percutaneous liver biopsy but liver biopsy is invasive and limited by cost sampling variability and intrareaderinterreader variability
Noninvasive modalities to risk stratify fibrotic NASH include serum biomarkers imaging and algorithms combining both The FibroScan-AST FAST composite score is based on the liver stiffness measure LSM controlled attenuation potential CAP and AST At the cut-off of a FAST score 067 biopsy-proven fibrotic NASH NAFLD with a histological NAFLD activity score NAS 4 and fibrosis 2 can be ruled in with 90 specificity
A new predictive model was recently developed based on eight variables age BMI HbA1c history of type 2 diabetes International normalized ratio INR AST Gamma Glutamyl transferase GGT and platelet count A composite score MAFLD Fibrosis Score MFS was calculated as MFS 0078 Age year-0007363 Platelet count 109L 00146 AST UL 0007618 GGT UL 6673 INR 009833 BMI kgm2 1425 type 2 diabetes yes 1 no 0
So in this study the investigators will try to evaluate the accuracy of the new emerging predictor MAFLD Fibrosis Score MFS vs AST- to-platelet ratio index APRI score fibrosis-4 index FIB-4 score and NAFLD fibrosis score in the assessment of the fibrotic NASH in Egyptian NAFLD patients
The incidence of MAFLD is increasing yearly and its incidence rate is as high as 20 to 30 on a global scale which seriously affects peoples health Non-alcoholic steatohepatitis NASH a chronic hepatitis that can progress to advanced fibrosis decompensated cirrhosis and hepatocellular carcinoma affects one-fifth of NAFLD patients Depending on the histological severity of fibrosis patients with NASH can be further classified as early NASH F0-F1 fibrosis fibrotic NASH F2 fibrosis or NASH-cirrhosis F4 fibrosis
Identifying subjects with fibrotic NASH is essential as they are at risk of complications and disease progression and may benefit from potential pharmacological therapy
Assessment of fibrotic NASH ranges from noninvasive scores to percutaneous liver biopsy but liver biopsy is invasive and limited by cost sampling variability and intrareaderinterreader variability
Noninvasive modalities to risk stratify fibrotic NASH include serum biomarkers imaging and algorithms combining both The FibroScan-AST FAST composite score is based on the liver stiffness measure LSM controlled attenuation potential CAP and AST At the cut-off of a FAST score 067 biopsy-proven fibrotic NASH NAFLD with a histological NAFLD activity score NAS 4 and fibrosis 2 can be ruled in with 90 specificity
A new predictive model was recently developed based on eight variables age BMI HbA1c history of type 2 diabetes International normalized ratio INR AST Gamma Glutamyl transferase GGT and platelet count A composite score MAFLD Fibrosis Score MFS was calculated as MFS 0078 Age year-0007363 Platelet count 109L 00146 AST UL 0007618 GGT UL 6673 INR 009833 BMI kgm2 1425 type 2 diabetes yes 1 no 0
So in this study the investigators will try to evaluate the accuracy of the new emerging predictor MAFLD Fibrosis Score MFS vs AST- to-platelet ratio index APRI score fibrosis-4 index FIB-4 score and NAFLD fibrosis score in the assessment of the fibrotic NASH in Egyptian NAFLD patients
Detailed Description:
This study will be a cross-sectional study and will be carried out on 380 MAFLD patients attending to Tanta tropical medicine outpatient clinic faculty of medicine The start of the research will be in March 2024 to August 2024 or until collecting the cases
Sample size The study will be carried on 382 patients according to the prevalence in Egypt 475 with confidence level 95 and margin of error 5 All the patients will be subjected to
History taking
Full history taking including
Personal history name age sex occupation residence and marital state
Anthropometric measures weight length BMI Waist circumference
Complaint
Investigations
Complete blood picture CBC
Lipid profile triglycerides HDL LDL cholesterol level
Fasting Blood glucose level and or HBA1C
Liver functions ALT AST INR GGT albumin bilirubin
Viral markers and Anti-nuclear antibody ANA Data of radiological examination
Fibroscan Liver fibrosis and steatosis can be staged using Dimensional ultrasound transient elastography TE
Ultrasound on abdomen and pelvis for evaluation of liver condition
Fibrotic NASH was diagnosed with FAST score with a cut-off 067 biopsy-proven fibrotic NASH NAFLD with a histological NAFLD activity score NAS 4 and fibrosis 2 8
MAFLD fibrosis score MFS is calculated using the formula
MFS 0078 Age year-0007363 Platelet count 109L 00146 AST UL 0007618 GGT UL 6673 INR 009833 BMI kgm2 1425 type 2 diabetes yes 1 no 09 - The FIB-4 index is calculated using the formula FIB-4 Age yearsASTUL platelet 109L ALT 12 UL
- NAFLD fibrosis score NFS is calculated using the formula NFS -1675 0037 age year 0094 BMI kgm2 113 impaired fasting glucose IFGdiabetes yes 1 no 0 099 ASTALT ratio - 0013 platelet count 109L - 066 albumin gdL
Ethical considerations
A written informed consent form authorizing the collection of this data was signed by all patients
The study will be approved by the Ethical Committee of the Faculty of Medicine at Tanta University
The risks to the participants and measures needed to minimize these risks
The privacy of the data of the patients will be maintained the procedure will be discussed later in this protocol
Any unexpected risks appeared during the course of research will be cleared to the patients and the ethical committee on time
Adequate provisions to maintain privacy of participants and confidentially of data are as follow
A code number for each patient will be used symbols to the name and address will be kept in a special file
The investigators will hide the patients names when the research is used
The investigators will use the results of the research only in scientific aim and not use it in other
Sample size The study will be carried on 382 patients according to the prevalence in Egypt 475 with confidence level 95 and margin of error 5 All the patients will be subjected to
History taking
Full history taking including
Personal history name age sex occupation residence and marital state
Anthropometric measures weight length BMI Waist circumference
Complaint
Investigations
Complete blood picture CBC
Lipid profile triglycerides HDL LDL cholesterol level
Fasting Blood glucose level and or HBA1C
Liver functions ALT AST INR GGT albumin bilirubin
Viral markers and Anti-nuclear antibody ANA Data of radiological examination
Fibroscan Liver fibrosis and steatosis can be staged using Dimensional ultrasound transient elastography TE
Ultrasound on abdomen and pelvis for evaluation of liver condition
Fibrotic NASH was diagnosed with FAST score with a cut-off 067 biopsy-proven fibrotic NASH NAFLD with a histological NAFLD activity score NAS 4 and fibrosis 2 8
MAFLD fibrosis score MFS is calculated using the formula
MFS 0078 Age year-0007363 Platelet count 109L 00146 AST UL 0007618 GGT UL 6673 INR 009833 BMI kgm2 1425 type 2 diabetes yes 1 no 09 - The FIB-4 index is calculated using the formula FIB-4 Age yearsASTUL platelet 109L ALT 12 UL
- NAFLD fibrosis score NFS is calculated using the formula NFS -1675 0037 age year 0094 BMI kgm2 113 impaired fasting glucose IFGdiabetes yes 1 no 0 099 ASTALT ratio - 0013 platelet count 109L - 066 albumin gdL
Ethical considerations
A written informed consent form authorizing the collection of this data was signed by all patients
The study will be approved by the Ethical Committee of the Faculty of Medicine at Tanta University
The risks to the participants and measures needed to minimize these risks
The privacy of the data of the patients will be maintained the procedure will be discussed later in this protocol
Any unexpected risks appeared during the course of research will be cleared to the patients and the ethical committee on time
Adequate provisions to maintain privacy of participants and confidentially of data are as follow
A code number for each patient will be used symbols to the name and address will be kept in a special file
The investigators will hide the patients names when the research is used
The investigators will use the results of the research only in scientific aim and not use it in other
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None