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

Diafir

Status

Completed

Conditions

Obesity

Treatments

Diagnostic Test: NASHMIR

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03978247

SIGNALS - 01

2018-A03240-55 (Other Identifier)

Details and patient eligibility

About

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

Full 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).

Enrollment

382 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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;