Signature Diagnostic of Non-alcoholic Steatohepatitis (NASH) by Infrared Light Spectroscopy

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Diagnostic Test: NASHMIR

• Registration Number: NCT03978247
• Lead Sponsor: Diafir

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).

Study Timeline

• Study First Submitted: 2019-04-23
• Study First Submitted QC: 2019-06-04
• Study First Posted: 2019-06-07
• Study Start: 2019-06-21
• Primary Completion: 2020-10-31
• Study Completion: 2020-10-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-03
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 382

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NASHMIR group	NASHMIR	Validation of the NASHMIR Test

Primary Outcome Measures

Name	Time	Method
Diagnostic performance	0-12 months	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

Name	Time	Method
Diagnostic performance considering size	0-12 months	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 weight of the patient at the age of 20	0-12 months	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 current weight	0-12 months	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 systolic blood pressure	0-12 months	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 sleep apnea	0-12 months	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 the concentration of total cholesterol	0-12 months	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 hip circumference	0-12 months	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 diastolic blood pressure	0-12 months	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 tobacco consumption	0-12 months	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 alcohol consumption	0-12 months	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 the leukocyte count	0-12 months	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 concentration of alanine aminotransferase	0-12 months	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	0-12 months	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 alkaline phosphatase	0-12 months	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 concentration of triglycerides	0-12 months	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 body mass index	0-12 months	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	0-12 months	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 type 2 diabetes	0-12 months	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 the concentration of bilirubin	0-12 months	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 LDL cholesterol	0-12 months	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 coffee consumption	0-12 months	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 the mean corpuscular volume	0-12 months	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 HbA1c level	0-12 months	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 ferritin	0-12 months	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 cannabis consumption	0-12 months	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	0-12 months	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 platelet count	0-12 months	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	0-12 months	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 prothrombin time	0-12 months	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	0-12 months	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 subtype of non-alcoholic steatohepatitis determined through analysis of biopsy samples	0-12 months	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)
Diagnostic performance considering the concentration of HDL cholesterol	0-12 months	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 C reactive protein	0-12 months	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 albumin	0-12 months	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.

Trial Locations

Locations (1)

CHU de Liège; 🇧🇪 Liège, Belgium