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

NCT ID: NCT03978247

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 382 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-21
• Study Completion Date: 2020-10-31

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).

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

NASHMIR group

Validation of the NASHMIR Test

Group Type: EXPERIMENTAL

NASHMIR

Intervention Type: DIAGNOSTIC_TEST

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).

Interventions

NASHMIR

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).

Intervention Type: DIAGNOSTIC_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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinact

OTHER

Sponsor Role: collaborator

Diafir

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rodolphe Anty, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

CHU de Liège

Liège, , Belgium

Countries

Belgium

References

Le Corvec M, Farrugia MA, Nguyen-Khac E, Regimbeau JM, Dharhri A, Chatelain D, Khamphommala L, Gautier AL, Le Berre N, Frey S, Bronowicki JP, Brunaud L, Marechal C, Blanchet MC, Frering V, Delwaide J, Kohnen L, Haumann A, Delvenne P, Sarfati-Lebreton M, Tariel H, Bernard J, Toullec A, Boursier J, Bedossa P, Gual P, Anty R, Iannelli A. Blood-based MASH diagnostic in candidates for bariatric surgery using mid-infrared spectroscopy: a European multicenter prospective study. Sci Rep. 2024 Nov 2;14(1):26452. doi: 10.1038/s41598-024-72704-5.

Reference Type: DERIVED

PMID: 39488538 (View on PubMed)

Other Identifiers

2018-A03240-55

Identifier Type: OTHER

Identifier Source: secondary_id

SIGNALS - 01

Identifier Type: -

Identifier Source: org_study_id