Back to resultsSignature Diagnostic of Non-alcoholic Steatohepatitis (NASH) by Infrared Light Spectroscopy (SIGNALS)
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
NASHMIR
Sponsored by
About this trial
This is an interventional screening trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- Patient over 18 years old;
- Patient able to read, write and understand the French language;
- Patient who has signed an informed consent form before carrying out any procedure related to the study;
- Patient supported in bariatric surgery;
- Patient affiliated to a social security scheme or comparable scheme
Exclusion Criteria:
- Patient who has already benefited from a bariatric surgery (ring, sleeve, bypass ..);
- Patient taking: corticosteroid for more than 2 months, amiodarone, methotrexate, tamoxifen, 5-fluorouracil, irinotecan, cisplatin, asparaginase, nucleoside reverse transcriptase inhibitors of HIV, tetracycline, valproic acid, perhexilline;
- Patient with excessive alcohol consumption (> 210 g/week in men,> 140 g/week in women) present or past;
- Patient with infection or coinfection present or passed with hepatitis B virus, hepatitis C virus or human immunodeficiency virus;
- Patient with known chronic liver disease (including hemochromatosis, autoimmune hepatitis ...);
- pregnant, parturient or nursing women;
- Patient deprived of liberty by judicial or administrative decision;
- Patient subject to a legal protection measure;
Sites / Locations
- CHU de Liège
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NASHMIR group
Arm Description
Validation of the NASHMIR Test
Outcomes
Primary Outcome Measures
Diagnostic performance
The comparison of the results obtained by the mathematical analysis of the infrared spectra with those obtained by the reference method on histological samples from liver biopsies will allow to classify the results in true-positive, false-positive, true-negative and false-negative.
The diagnostic performance of the signature will be evaluated by calculating the sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio values.
Secondary Outcome Measures
Diagnostic performance considering size
Diagnostic performance of the test taking into account size (cm). Significance of each clinical parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant clinical variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering current weight
Diagnostic performance of the test taking into account current weight (kg). Significance of each clinical parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant clinical variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering weight of the patient at the age of 20
Diagnostic performance of the test taking into account Weight of the patient at the age of 20 (kg).
Significance of each clinical parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant clinical variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering body mass index
Diagnostic performance of the test taking into account BMI (Body Mass Index) (kg/m2).
Significance of each clinical parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant clinical variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering waist
Diagnostic performance of the test taking into account waist (cm). Significance of each clinical parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant clinical variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering hip circumference
Diagnostic performance of the test taking into account Hip circumference (cm). Significance of each clinical parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant clinical variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering systolic blood pressure
Diagnostic performance of the test taking into account systolic blood pressure (mmHg).
Significance of each clinical parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant clinical variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering diastolic blood pressure
Diagnostic performance of the test taking into account diastolic blood pressure (mmHg).
Significance of each clinical parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant clinical variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering type 2 diabetes
Diagnostic performance of the test taking into account type 2 diabetes (yes/No).
Significance of each clinical parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant clinical variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering sleep apnea
Diagnostic performance of the test taking into account sleep apnea (Yes/No). Significance of each clinical parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant clinical variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering alcohol consumption
Diagnostic performance of the test taking into account current and/or previous alcohol consumption (Date and number of drinks per week).
Significance of each clinical parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant clinical variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering tobacco consumption
Diagnostic performance of the test taking into account current and/or previous tobacco consumption (date and number of pack of cigarettes per year).
Significance of each clinical parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant clinical variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering coffee consumption
Diagnostic performance of the test taking into account coffee consumption (number of cups per day).
Significance of each clinical parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant clinical variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering cannabis consumption
Diagnostic performance of the test taking into account cannabis consumption (number of joints per week).
Significance of each clinical parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant clinical variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering the hemoglobin concentration
Diagnostic performance of the test taking into account the hemoglobin concentration (g/100mL).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering the mean corpuscular volume
Diagnostic performance of the test taking into account mean corpuscular volume (fL).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering the leukocyte count
Diagnostic performance of the test taking into account leukocyte count (Giga/L).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering the platelet count
Diagnostic performance of the test taking into account platelet count (Giga/L). Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering the concentration of aspartate transaminase
Diagnostic performance of the test taking into account aspartate transaminase (UI/L).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering the concentration of alanine aminotransferase
Diagnostic performance of the test taking into account alanine aminotransferase (UI/L).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering the concentration of gamma-glutamyl transferase
Diagnostic performance of the test taking into account the concentration of gamma-glutamyl transferase (UI/L).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering the concentration of bilirubin
Diagnostic performance of the test taking into account the concentration of bilirubin (mg/dL).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering the concentration of alkaline phosphatase
Diagnostic performance of the test taking into account the concentration of alkaline phosphatase (UI/L).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering the prothrombin time
Diagnostic performance of the test taking into account the prothrombin time (%).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering the blood glucose level
Diagnostic performance of the test taking into account the blood glucose level (mmol/L).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering the HbA1c level
Diagnostic performance of the test taking into account the HbA1c level (hemoglobin A1c) (%).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering the concentration of total cholesterol
Diagnostic performance of the test taking into account the concentration of total cholesterol (mmol/L).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering the concentration of HDL cholesterol
Diagnostic performance of the test taking into account the concentration of HDL cholesterol (mmol/L).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering the concentration of LDL cholesterol
Diagnostic performance of the test taking into account the concentration of LDL cholesterol (mmol/L).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering the concentration of triglycerides
Diagnostic performance of the test taking into account the concentration of triglyceride (mmol/L).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering the concentration of C reactive protein
Diagnostic performance of the test taking into account the concentration of C reactive protein (mg/L).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering the concentration of ferritin
Diagnostic performance of the test taking into account the concentration of ferritin (g/L).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering the concentration of albumin
Diagnostic performance of the test taking into account the concentration of albumin (g/L).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Diagnostic performance considering the subtype of non-alcoholic steatohepatitis determined through analysis of biopsy samples
Diagnostic performance of the test according to the different subtypes of non-alcoholic steatohepatitis (NAS score). NAFLD Activity Score calculated according to the steatosis grade (0, 1, 2 or 3), level of lobular inflammation (0, 1, 2 or 3) and stages of liver cell injury (0, 1 or 2)
Full Information
NCT ID
NCT03978247
First Posted
April 23, 2019
Last Updated
February 3, 2021
Sponsor
Diafir
Collaborators
Clinact
1. Study Identification
Unique Protocol Identification Number
NCT03978247
Brief Title
Signature Diagnostic of Non-alcoholic Steatohepatitis (NASH) by Infrared Light Spectroscopy
Acronym
SIGNALS
Official Title
Validation Study of the NASHMIR Test for Non-alcoholic Steatohepatitis (NASH) Diagnosis in Patients With Severe or Morbid Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 21, 2019 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
October 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Diafir
Collaborators
Clinact
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of the diagnostic performance of an algorithm developed to detect metabolic profiles specific of non-alcoholic steatohepatitis NASH and based on the reading of a blood sample's infrared spectra
Detailed Description
The study is aimed at patients suffering from severe or morbid obesity and engaged in a bariatric surgery course. An additional blood sample will be taken upstream of the surgical procedure in the fasted subject. The metabolic fingerprint of the patient will be analyzed on serum from spectral data measured at most two hours after collection. The spectra obtained by the spectroscopy platform will be processed by algorithmic analysis to build the diagnostic test.
During the surgical procedure, a liver biopsy will be performed. The sample will be sent to the pathology laboratory for preparation and the slides will then be anonymized to be sent to a specialized laboratory for centralized reading by an expert pathologist. This expert will determine the diagnosis of non-alcoholic steatohepatitis (NASH) or non-NASH after microscopic analysis of the sample without having any information about the patient.
The two results obtained by the spectroscopic test and by means of the biopsy will then be compared to determine the diagnostic performance of the developped test (NASHMIR test).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study is aimed at patients suffering from severe or morbid obesity and engaged in a bariatric surgery course. An additional blood sample will be taken upstream of the surgical procedure in the fasted subject. During the surgical procedure, a liver biopsy will be performed. The two diagnosis determined by the spectroscopic test and by means of the biopsy will then be compared to determine the diagnostic performance of the developped test (NASHMIR test).
Masking
None (Open Label)
Allocation
N/A
Enrollment
382 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NASHMIR group
Arm Type
Experimental
Arm Description
Validation of the NASHMIR Test
Intervention Type
Diagnostic Test
Intervention Name(s)
NASHMIR
Intervention Description
An additional blood sample will be taken upstream of the surgical procedure and a liver biopsy will be performed in all included patients. The two results obtained by the spectroscopic test and by means of the biopsy will then be compared to determine the diagnostic performance of the developped test (NASHMIR test).
Primary Outcome Measure Information:
Title
Diagnostic performance
Description
The comparison of the results obtained by the mathematical analysis of the infrared spectra with those obtained by the reference method on histological samples from liver biopsies will allow to classify the results in true-positive, false-positive, true-negative and false-negative.
The diagnostic performance of the signature will be evaluated by calculating the sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio values.
Time Frame
0-12 months
Secondary Outcome Measure Information:
Title
Diagnostic performance considering size
Description
Diagnostic performance of the test taking into account size (cm). Significance of each clinical parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant clinical variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering current weight
Description
Diagnostic performance of the test taking into account current weight (kg). Significance of each clinical parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant clinical variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering weight of the patient at the age of 20
Description
Diagnostic performance of the test taking into account Weight of the patient at the age of 20 (kg).
Significance of each clinical parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant clinical variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering body mass index
Description
Diagnostic performance of the test taking into account BMI (Body Mass Index) (kg/m2).
Significance of each clinical parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant clinical variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering waist
Description
Diagnostic performance of the test taking into account waist (cm). Significance of each clinical parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant clinical variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering hip circumference
Description
Diagnostic performance of the test taking into account Hip circumference (cm). Significance of each clinical parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant clinical variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering systolic blood pressure
Description
Diagnostic performance of the test taking into account systolic blood pressure (mmHg).
Significance of each clinical parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant clinical variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering diastolic blood pressure
Description
Diagnostic performance of the test taking into account diastolic blood pressure (mmHg).
Significance of each clinical parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant clinical variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering type 2 diabetes
Description
Diagnostic performance of the test taking into account type 2 diabetes (yes/No).
Significance of each clinical parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant clinical variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering sleep apnea
Description
Diagnostic performance of the test taking into account sleep apnea (Yes/No). Significance of each clinical parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant clinical variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering alcohol consumption
Description
Diagnostic performance of the test taking into account current and/or previous alcohol consumption (Date and number of drinks per week).
Significance of each clinical parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant clinical variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering tobacco consumption
Description
Diagnostic performance of the test taking into account current and/or previous tobacco consumption (date and number of pack of cigarettes per year).
Significance of each clinical parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant clinical variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering coffee consumption
Description
Diagnostic performance of the test taking into account coffee consumption (number of cups per day).
Significance of each clinical parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant clinical variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering cannabis consumption
Description
Diagnostic performance of the test taking into account cannabis consumption (number of joints per week).
Significance of each clinical parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant clinical variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering the hemoglobin concentration
Description
Diagnostic performance of the test taking into account the hemoglobin concentration (g/100mL).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering the mean corpuscular volume
Description
Diagnostic performance of the test taking into account mean corpuscular volume (fL).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering the leukocyte count
Description
Diagnostic performance of the test taking into account leukocyte count (Giga/L).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering the platelet count
Description
Diagnostic performance of the test taking into account platelet count (Giga/L). Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering the concentration of aspartate transaminase
Description
Diagnostic performance of the test taking into account aspartate transaminase (UI/L).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering the concentration of alanine aminotransferase
Description
Diagnostic performance of the test taking into account alanine aminotransferase (UI/L).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering the concentration of gamma-glutamyl transferase
Description
Diagnostic performance of the test taking into account the concentration of gamma-glutamyl transferase (UI/L).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering the concentration of bilirubin
Description
Diagnostic performance of the test taking into account the concentration of bilirubin (mg/dL).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering the concentration of alkaline phosphatase
Description
Diagnostic performance of the test taking into account the concentration of alkaline phosphatase (UI/L).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering the prothrombin time
Description
Diagnostic performance of the test taking into account the prothrombin time (%).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering the blood glucose level
Description
Diagnostic performance of the test taking into account the blood glucose level (mmol/L).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering the HbA1c level
Description
Diagnostic performance of the test taking into account the HbA1c level (hemoglobin A1c) (%).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering the concentration of total cholesterol
Description
Diagnostic performance of the test taking into account the concentration of total cholesterol (mmol/L).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering the concentration of HDL cholesterol
Description
Diagnostic performance of the test taking into account the concentration of HDL cholesterol (mmol/L).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering the concentration of LDL cholesterol
Description
Diagnostic performance of the test taking into account the concentration of LDL cholesterol (mmol/L).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering the concentration of triglycerides
Description
Diagnostic performance of the test taking into account the concentration of triglyceride (mmol/L).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering the concentration of C reactive protein
Description
Diagnostic performance of the test taking into account the concentration of C reactive protein (mg/L).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering the concentration of ferritin
Description
Diagnostic performance of the test taking into account the concentration of ferritin (g/L).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering the concentration of albumin
Description
Diagnostic performance of the test taking into account the concentration of albumin (g/L).
Significance of each biological parameter will be assessed using statistical tests (mean comparison) on the two main populations (Non Alcoholic Steato Hepatitis Yes or No). Using logistic regression, a score calculated with significant biological variables will be aggregated to spectral score (primary outcome) in order to assess new diagnostic performance.
Time Frame
0-12 months
Title
Diagnostic performance considering the subtype of non-alcoholic steatohepatitis determined through analysis of biopsy samples
Description
Diagnostic performance of the test according to the different subtypes of non-alcoholic steatohepatitis (NAS score). NAFLD Activity Score calculated according to the steatosis grade (0, 1, 2 or 3), level of lobular inflammation (0, 1, 2 or 3) and stages of liver cell injury (0, 1 or 2)
Time Frame
0-12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient over 18 years old;
Patient able to read, write and understand the French language;
Patient who has signed an informed consent form before carrying out any procedure related to the study;
Patient supported in bariatric surgery;
Patient affiliated to a social security scheme or comparable scheme
Exclusion Criteria:
Patient who has already benefited from a bariatric surgery (ring, sleeve, bypass ..);
Patient taking: corticosteroid for more than 2 months, amiodarone, methotrexate, tamoxifen, 5-fluorouracil, irinotecan, cisplatin, asparaginase, nucleoside reverse transcriptase inhibitors of HIV, tetracycline, valproic acid, perhexilline;
Patient with excessive alcohol consumption (> 210 g/week in men,> 140 g/week in women) present or past;
Patient with infection or coinfection present or passed with hepatitis B virus, hepatitis C virus or human immunodeficiency virus;
Patient with known chronic liver disease (including hemochromatosis, autoimmune hepatitis ...);
pregnant, parturient or nursing women;
Patient deprived of liberty by judicial or administrative decision;
Patient subject to a legal protection measure;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodolphe Anty, MD, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Signature Diagnostic of Non-alcoholic Steatohepatitis (NASH) by Infrared Light Spectroscopy
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