Clinical trial NCT03978247: Signature Diagnostic of Non-alcoholic Steatohepatitis (NASH) by Infrared Light Spectroscopy
Official title: Validation Study of the NASHMIR Test for Non-alcoholic Steatohepatitis (NASH) Diagnosis in Patients With Severe or Morbid Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Diafir
Sponsor class: INDUSTRY
Collaborators: name: Clinact
First posted: 2019-06-07
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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).
Primary purpose: SCREENING

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).

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;

Primary outcomes:
measure: Diagnostic performance
timeFrame: 0-12 months
Secondary outcomes:
measure: Diagnostic performance considering size
timeFrame: 0-12 months
measure: Diagnostic performance considering current weight
timeFrame: 0-12 months
measure: Diagnostic performance considering weight of the patient at the age of 20
timeFrame: 0-12 months
measure: Diagnostic performance considering body mass index
timeFrame: 0-12 months
measure: Diagnostic performance considering waist
timeFrame: 0-12 months
measure: Diagnostic performance considering hip circumference
timeFrame: 0-12 months
measure: Diagnostic performance considering systolic blood pressure
timeFrame: 0-12 months
measure: Diagnostic performance considering diastolic blood pressure
timeFrame: 0-12 months
measure: Diagnostic performance considering type 2 diabetes
timeFrame: 0-12 months
measure: Diagnostic performance considering sleep apnea
timeFrame: 0-12 months
measure: Diagnostic performance considering alcohol consumption
timeFrame: 0-12 months
measure: Diagnostic performance considering tobacco consumption
timeFrame: 0-12 months
measure: Diagnostic performance considering coffee consumption
timeFrame: 0-12 months
measure: Diagnostic performance considering cannabis consumption
timeFrame: 0-12 months
measure: Diagnostic performance considering the hemoglobin concentration
timeFrame: 0-12 months
measure: Diagnostic performance considering the mean corpuscular volume
timeFrame: 0-12 months
measure: Diagnostic performance considering the leukocyte count
timeFrame: 0-12 months
measure: Diagnostic performance considering the platelet count
timeFrame: 0-12 months
measure: Diagnostic performance considering the concentration of aspartate transaminase
timeFrame: 0-12 months
measure: Diagnostic performance considering the concentration of alanine aminotransferase
timeFrame: 0-12 months
measure: Diagnostic performance considering the concentration of gamma-glutamyl transferase
timeFrame: 0-12 months
measure: Diagnostic performance considering the concentration of bilirubin
timeFrame: 0-12 months
measure: Diagnostic performance considering the concentration of alkaline phosphatase
timeFrame: 0-12 months
measure: Diagnostic performance considering the prothrombin time
timeFrame: 0-12 months
measure: Diagnostic performance considering the blood glucose level
timeFrame: 0-12 months
measure: Diagnostic performance considering the HbA1c level
timeFrame: 0-12 months
measure: Diagnostic performance considering the concentration of total cholesterol
timeFrame: 0-12 months
measure: Diagnostic performance considering the concentration of HDL cholesterol
timeFrame: 0-12 months
measure: Diagnostic performance considering the concentration of LDL cholesterol
timeFrame: 0-12 months
measure: Diagnostic performance considering the concentration of triglycerides
timeFrame: 0-12 months
measure: Diagnostic performance considering the concentration of C reactive protein
timeFrame: 0-12 months
measure: Diagnostic performance considering the concentration of ferritin
timeFrame: 0-12 months
measure: Diagnostic performance considering the concentration of albumin
timeFrame: 0-12 months
measure: Diagnostic performance considering the subtype of non-alcoholic steatohepatitis determined through analysis of biopsy samples
timeFrame: 0-12 months
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHU de Liège
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Rodolphe Anty, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: