Validation Study of the NASHMIR Test for Non-alcoholic Steatohepatitis (NASH) Diagnosis in Patients With Severe or Morbid Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Diafir
- 入组人数
- 382
- 试验地点
- 2
- 主要终点
- Diagnostic performance
研究概览
简要总结
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
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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;
结局指标
主要结局
Diagnostic performance
时间窗: 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.
次要结局
- Diagnostic performance considering size(0-12 months)
- Diagnostic performance considering weight of the patient at the age of 20(0-12 months)
- Diagnostic performance considering current weight(0-12 months)
- Diagnostic performance considering systolic blood pressure(0-12 months)
- Diagnostic performance considering sleep apnea(0-12 months)
- Diagnostic performance considering the concentration of total cholesterol(0-12 months)
- Diagnostic performance considering hip circumference(0-12 months)
- Diagnostic performance considering diastolic blood pressure(0-12 months)
- Diagnostic performance considering tobacco consumption(0-12 months)
- Diagnostic performance considering alcohol consumption(0-12 months)
- Diagnostic performance considering the leukocyte count(0-12 months)
- Diagnostic performance considering the concentration of alanine aminotransferase(0-12 months)
- Diagnostic performance considering the concentration of gamma-glutamyl transferase(0-12 months)
- Diagnostic performance considering the concentration of alkaline phosphatase(0-12 months)
- Diagnostic performance considering the concentration of triglycerides(0-12 months)
- Diagnostic performance considering body mass index(0-12 months)
- Diagnostic performance considering waist(0-12 months)
- Diagnostic performance considering type 2 diabetes(0-12 months)
- Diagnostic performance considering the concentration of bilirubin(0-12 months)
- Diagnostic performance considering the concentration of LDL cholesterol(0-12 months)
- Diagnostic performance considering coffee consumption(0-12 months)
- Diagnostic performance considering the mean corpuscular volume(0-12 months)
- Diagnostic performance considering the HbA1c level(0-12 months)
- Diagnostic performance considering the concentration of ferritin(0-12 months)
- Diagnostic performance considering cannabis consumption(0-12 months)
- Diagnostic performance considering the hemoglobin concentration(0-12 months)
- Diagnostic performance considering the platelet count(0-12 months)
- Diagnostic performance considering the concentration of aspartate transaminase(0-12 months)
- Diagnostic performance considering the prothrombin time(0-12 months)
- Diagnostic performance considering the blood glucose level(0-12 months)
- Diagnostic performance considering the subtype of non-alcoholic steatohepatitis determined through analysis of biopsy samples(0-12 months)
- Diagnostic performance considering the concentration of HDL cholesterol(0-12 months)
- Diagnostic performance considering the concentration of C reactive protein(0-12 months)
- Diagnostic performance considering the concentration of albumin(0-12 months)