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Signature Diagnostic of Non-alcoholic Steatohepatitis (NASH) by Infrared Light Spectroscopy (SIGNALS)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Obesity | Diagnostic Test: NASHMIR | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 382 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention 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) |
| Primary Purpose: | Screening |
| Official Title: | Validation Study of the NASHMIR Test for Non-alcoholic Steatohepatitis (NASH) Diagnosis in Patients With Severe or Morbid Obesity |
| Actual Study Start Date : | June 21, 2019 |
| Actual Primary Completion Date : | October 31, 2020 |
| Actual Study Completion Date : | October 31, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: NASHMIR group
Validation of the NASHMIR Test
|
Diagnostic Test: 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).
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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)
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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;
| Belgium | |
| CHU de Liège | |
| Liège, Belgium, 4000 | |
| Principal Investigator: | Rodolphe Anty, MD, PhD | Centre Hospitalier Universitaire de Nice |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 23, 2019 | ||||
| First Posted Date ICMJE | June 7, 2019 | ||||
| Last Update Posted Date | February 4, 2021 | ||||
| Actual Study Start Date ICMJE | June 21, 2019 | ||||
| Actual Primary Completion Date | October 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Signature Diagnostic of Non-alcoholic Steatohepatitis (NASH) by Infrared Light Spectroscopy | ||||
| Official Title ICMJE | Validation Study of the NASHMIR Test for Non-alcoholic Steatohepatitis (NASH) Diagnosis in Patients With Severe or Morbid Obesity | ||||
| 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). |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention 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)Primary Purpose: Screening |
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| Condition ICMJE | Obesity | ||||
| Intervention ICMJE | Diagnostic Test: 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).
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| Study Arms ICMJE | Experimental: NASHMIR group
Validation of the NASHMIR Test
Intervention: Diagnostic Test: NASHMIR
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
382 | ||||
| Original Estimated Enrollment ICMJE |
500 | ||||
| Actual Study Completion Date ICMJE | October 31, 2020 | ||||
| Actual Primary Completion Date | October 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Belgium | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03978247 | ||||
| Other Study ID Numbers ICMJE | SIGNALS - 01 2018-A03240-55 ( Other Identifier: ANSM (ID-RCB) ) |
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| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Diafir | ||||
| Study Sponsor ICMJE | Diafir | ||||
| Collaborators ICMJE | Clinact | ||||
| Investigators ICMJE |
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| PRS Account | Diafir | ||||
| Verification Date | February 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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