Diagnosis method of inflammatory, fibrotic or cancerous disease using biochemical markers
AssigneeAssistance Publique-Hopitaux De Paris (Ap-HP)
InventorThierry Poynard
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Abstract
The present invention is drawn to a new diagnosis method for detecting the extend of a inflammatory, fibrotic or cancerous disease in a patient, in particular liver fibrosis, in particular in a patient infected with hepatitis C virus, by using the serum concentration of easily detectable biological markers. The invention is also drawn to diagnosis kits for the implementation of the method.
Claims16
A method for diagnosis of liver fibrosis and/or presence of liver necroinflammatory lesions in a patient comprising the steps of:
- a) studying at least 4 biochemical markers by measuring the values of their concentration in the serum or plasma of said patient, wherein said markers are chosen from the group consisting of α2-macroglobulin, AST (aspartate aminotransferase), ALT (alanine aminotransferasc), GGT (gammaglutamyl transpeptidase), γ-globulin, total bilirubin, albumin, α1-globulin, α2-globulin, haptoglobin, β-globulin, apoA1, IL-10, TGF-β1, apoA2, and apoB;
- b) combining said values through a logistic function including said markers in order to obtain an end value, wherein said logistic function is obtained through the following method:
- i) classification of a cohort of patients in different groups according to the extent of their disease;
- ii) identification of factors which differ significantly between these groups by unidimensional analysis;
- iii) logistic regression analysis to assess the independent discriminative value of markers for the diagnosis of fibrosis and/or liver necroinflammatory lesions;
- iv) construction of the logistic function by combination of these identified independent factors;
- and
- c) analyzing said end value of said logistic function in order to determine the presence of liver fibrosis and/or liver necroinflammatory lesions in said patient.
A kit for diagnosis of liver fibrosis and/or liver necroinflammatory lesions in a patient comprising:
- a) instructions for determining the presence of liver fibrosis and/or liver necroinflammatory lesions in said patient;
- b) reagents for measuring the serum values of the concentrations of at least four biochemical markers, wherein said markers are chosen from the group consisting of α2-macroglobulin, AST (aspartate aminotransferase), ALT (alanine aminotransferase), GGT (gammaglutamyl transpeptidase), γ-globulin, total bilirubin, albumin, α1-globulin, α2-globulin, haptoglobin, β-globulin, apoA1, IL-10, TGF-β1, apoA2, and apoB;
- and
- c) instructions for using a logistic function that is used to combine said values in order to obtain an end value, wherein analysis of said end value determines the presence of liver fibrosis and/or liver necroinflammatory lesions in said patient.
Dependencies are inferred from the claim text.