ObesitySIGNALSNCT03978247
Signature Diagnostic of Non-alcoholic Steatohepatitis (NASH) by Infrared Light Spectroscopy
A study testing NASHMIR in people with Obesity, run by Diafir at 1 site in Belgium.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obesity
- What is being tested?
- NASHMIR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Jun 2019to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation Study of the NASHMIR Test for Non-alcoholic Steatohepatitis (NASH) Diagnosis in Patients With Severe or Morbid Obesity
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
Read the 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
- Being tested
- NASHMIR
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NASHMIRDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| NASHMIR group | Experimental | Validation of the NASHMIR Test Receives: Diagnostic Test: NASHMIR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-12 months
Secondary outcomes (34)
Diagnostic performance considering size
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.
Measured: 0-12 months
Diagnostic performance considering current weight
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.
Measured: 0-12 months
Diagnostic performance considering weight of the patient at the age of 20
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.
Measured: 0-12 months
Diagnostic performance considering body mass index
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.
Measured: 0-12 months
Diagnostic performance considering waist
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.
Measured: 0-12 months
Diagnostic performance considering hip circumference
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.
Measured: 0-12 months
Diagnostic performance considering systolic blood pressure
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.
Measured: 0-12 months
Diagnostic performance considering diastolic blood pressure
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.
Measured: 0-12 months
Diagnostic performance considering type 2 diabetes
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.
Measured: 0-12 months
Diagnostic performance considering sleep apnea
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.
Measured: 0-12 months
Diagnostic performance considering alcohol consumption
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.
Measured: 0-12 months
Diagnostic performance considering tobacco consumption
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.
Measured: 0-12 months
Diagnostic performance considering coffee consumption
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.
Measured: 0-12 months
Diagnostic performance considering cannabis consumption
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.
Measured: 0-12 months
Diagnostic performance considering the hemoglobin concentration
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.
Measured: 0-12 months
Diagnostic performance considering the mean corpuscular volume
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.
Measured: 0-12 months
Diagnostic performance considering the leukocyte count
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.
Measured: 0-12 months
Diagnostic performance considering the platelet count
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.
Measured: 0-12 months
Diagnostic performance considering the concentration of aspartate transaminase
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.
Measured: 0-12 months
Diagnostic performance considering the concentration of alanine aminotransferase
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.
Measured: 0-12 months
Diagnostic performance considering the concentration of gamma-glutamyl transferase
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.
Measured: 0-12 months
Diagnostic performance considering the concentration of bilirubin
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.
Measured: 0-12 months
Diagnostic performance considering the concentration of alkaline phosphatase
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.
Measured: 0-12 months
Diagnostic performance considering the prothrombin time
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.
Measured: 0-12 months
Diagnostic performance considering the blood glucose level
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.
Measured: 0-12 months
Diagnostic performance considering the HbA1c level
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.
Measured: 0-12 months
Diagnostic performance considering the concentration of total cholesterol
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.
Measured: 0-12 months
Diagnostic performance considering the concentration of HDL cholesterol
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.
Measured: 0-12 months
Diagnostic performance considering the concentration of LDL cholesterol
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.
Measured: 0-12 months
Diagnostic performance considering the concentration of triglycerides
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.
Measured: 0-12 months
Diagnostic performance considering the concentration of C reactive protein
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.
Measured: 0-12 months
Diagnostic performance considering the concentration of ferritin
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.
Measured: 0-12 months
Diagnostic performance considering the concentration of albumin
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.
Measured: 0-12 months
Diagnostic performance considering the subtype of non-alcoholic steatohepatitis determined through analysis of biopsy samples
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)
Measured: 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start21 Jun 2019
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- 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).
- Masking
- None (open label)
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diafir
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinact
- Responsible party
- Sponsor
- Investigators
- Rodolphe Anty, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978247
- Sponsor's protocol ID
- SIGNALS - 01
- Other IDs
- 2018-A03240-55
- Acronym
- SIGNALS
- Status last verified
- Feb 2021
- First submitted
- 23 Apr 2019
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39488538
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study of the NASHMIR Test for Non-alcoholic Steatohepatitis (NASH) Diagnosis in Patients With Severe or Morbid Obesity
- ClinicalTrials.gov ID
- NCT03978247
- Acronym / sponsor ID
- SIGNALS / SIGNALS - 01
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- DiafirIndustry (pharma, biotech, devices)
- Collaborators
- Clinact
- Study start
- 21 Jun 2019 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| NASHMIR group | Experimental | Diagnostic Test: NASHMIRValidation of the NASHMIR Test |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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 ...);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NASHMIRAn 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). | Diagnostic test | NASHMIR group |
Primary outcome
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.
34 secondary outcomes
Diagnostic performance considering size
Time frame: 0-12 months
Diagnostic performance considering current weight
Time frame: 0-12 months
Diagnostic performance considering weight of the patient at the age of 20
Time frame: 0-12 months
Diagnostic performance considering body mass index
Time frame: 0-12 months
Diagnostic performance considering waist
Time frame: 0-12 months
Diagnostic performance considering hip circumference
Time frame: 0-12 months
Diagnostic performance considering systolic blood pressure
Time frame: 0-12 months
Diagnostic performance considering diastolic blood pressure
Time frame: 0-12 months
Diagnostic performance considering type 2 diabetes
Time frame: 0-12 months
Diagnostic performance considering sleep apnea
Time frame: 0-12 months
Diagnostic performance considering alcohol consumption
Time frame: 0-12 months
Diagnostic performance considering tobacco consumption
Time frame: 0-12 months
Diagnostic performance considering coffee consumption
Time frame: 0-12 months
Diagnostic performance considering cannabis consumption
Time frame: 0-12 months
Diagnostic performance considering the hemoglobin concentration
Time frame: 0-12 months
Diagnostic performance considering the mean corpuscular volume
Time frame: 0-12 months
Diagnostic performance considering the leukocyte count
Time frame: 0-12 months
Diagnostic performance considering the platelet count
Time frame: 0-12 months
Diagnostic performance considering the concentration of aspartate transaminase
Time frame: 0-12 months
Diagnostic performance considering the concentration of alanine aminotransferase
Time frame: 0-12 months
Diagnostic performance considering the concentration of gamma-glutamyl transferase
Time frame: 0-12 months
Diagnostic performance considering the concentration of bilirubin
Time frame: 0-12 months
Diagnostic performance considering the concentration of alkaline phosphatase
Time frame: 0-12 months
Diagnostic performance considering the prothrombin time
Time frame: 0-12 months
Diagnostic performance considering the blood glucose level
Time frame: 0-12 months
Diagnostic performance considering the HbA1c level
Time frame: 0-12 months
Diagnostic performance considering the concentration of total cholesterol
Time frame: 0-12 months
Diagnostic performance considering the concentration of HDL cholesterol
Time frame: 0-12 months
Diagnostic performance considering the concentration of LDL cholesterol
Time frame: 0-12 months
Diagnostic performance considering the concentration of triglycerides
Time frame: 0-12 months
Diagnostic performance considering the concentration of C reactive protein
Time frame: 0-12 months
Diagnostic performance considering the concentration of ferritin
Time frame: 0-12 months
Diagnostic performance considering the concentration of albumin
Time frame: 0-12 months
Diagnostic performance considering the subtype of non-alcoholic steatohepatitis determined through analysis of biopsy samples
Time frame: 0-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Derived from this study: PubMed 39488538Le 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodolphe Anty, MD, PhD principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NASHMIR in people with Obesity, run by Diafir at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance (time frame: 0-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03978247, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.