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NCT Number: NCT03978247

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

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

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Liège

Liège, 4000, Belgium

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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).

Primary outcomes

  1. Diagnostic performance

    Time frame: 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 outcomes

  1. Diagnostic performance considering size

    Time frame: 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.

  2. Diagnostic performance considering current weight

    Time frame: 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.

  3. Diagnostic performance considering weight of the patient at the age of 20

    Time frame: 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.

  4. Diagnostic performance considering body mass index

    Time frame: 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.

  5. Diagnostic performance considering waist

    Time frame: 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.

  6. Diagnostic performance considering hip circumference

    Time frame: 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.

  7. Diagnostic performance considering systolic blood pressure

    Time frame: 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.

  8. Diagnostic performance considering diastolic blood pressure

    Time frame: 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.

  9. Diagnostic performance considering type 2 diabetes

    Time frame: 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.

  10. Diagnostic performance considering sleep apnea

    Time frame: 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.

  11. Diagnostic performance considering alcohol consumption

    Time frame: 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.

  12. Diagnostic performance considering tobacco consumption

    Time frame: 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.

  13. Diagnostic performance considering coffee consumption

    Time frame: 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.

  14. Diagnostic performance considering cannabis consumption

    Time frame: 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.

  15. Diagnostic performance considering the hemoglobin concentration

    Time frame: 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.

  16. Diagnostic performance considering the mean corpuscular volume

    Time frame: 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.

  17. Diagnostic performance considering the leukocyte count

    Time frame: 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.

  18. Diagnostic performance considering the platelet count

    Time frame: 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.

  19. Diagnostic performance considering the concentration of aspartate transaminase

    Time frame: 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.

  20. Diagnostic performance considering the concentration of alanine aminotransferase

    Time frame: 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.

  21. Diagnostic performance considering the concentration of gamma-glutamyl transferase

    Time frame: 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.

  22. Diagnostic performance considering the concentration of bilirubin

    Time frame: 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.

  23. Diagnostic performance considering the concentration of alkaline phosphatase

    Time frame: 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.

  24. Diagnostic performance considering the prothrombin time

    Time frame: 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.

  25. Diagnostic performance considering the blood glucose level

    Time frame: 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.

  26. Diagnostic performance considering the HbA1c level

    Time frame: 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.

  27. Diagnostic performance considering the concentration of total cholesterol

    Time frame: 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.

  28. Diagnostic performance considering the concentration of HDL cholesterol

    Time frame: 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.

  29. Diagnostic performance considering the concentration of LDL cholesterol

    Time frame: 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.

  30. Diagnostic performance considering the concentration of triglycerides

    Time frame: 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.

  31. Diagnostic performance considering the concentration of C reactive protein

    Time frame: 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.

  32. Diagnostic performance considering the concentration of ferritin

    Time frame: 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.

  33. Diagnostic performance considering the concentration of albumin

    Time frame: 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.

  34. Diagnostic performance considering the subtype of non-alcoholic steatohepatitis determined through analysis of biopsy samples

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Diafir

Industry

Collaborators

  • Clinact

Registry information

Official study title

Validation Study of the NASHMIR Test for Non-alcoholic Steatohepatitis (NASH) Diagnosis in Patients With Severe or Morbid Obesity

Acronym: SIGNALS

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 7, 2019
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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