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

NCT03978247 | Completed

• 2 other identifiers: SIGNALS - 012018-A03240-55
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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.

  0-12 months

Secondary Outcomes (34)

• Diagnostic performance considering size

  0-12 months

• Diagnostic performance considering current weight

  0-12 months

• Diagnostic performance considering weight of the patient at the age of 20

  0-12 months

• Diagnostic performance considering body mass index

  0-12 months

• Diagnostic performance considering waist

  0-12 months

Study Arms (1)

NASHMIR group

EXPERIMENTAL

Validation of the NASHMIR Test

Diagnostic Test: NASHMIR

Interventions

NASHMIR 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).

NASHMIR group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Diafir: lead
• Clinact: collaborator

Study Sites (1)

CHU de Liège

Liège, 4000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 39488538 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rodolphe Anty, MD, PhD

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: June 7, 2019
• Study Start: June 21, 2019
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)