Microbiome as a biomarker for prostate cancer
AssigneesBoard of Regents, The University of Texas System, The United States Government as represented by the Department of Veterans Affairs
InventorMichael A. LISS
Life of this patent
Estimating the term…
Abstract
Systems and methods are provided for a gut microbiome signature for cancers, including prostate cancer (PCa), using a prostate specific antigen (PSA)-independent, gut microbiome-based PCa biomarker, which can be used for diagnosis, suitability' for screening, treatment decisions and as part of a treatment method.
Claims30
A method of determining whether a gut microbiome sample from a human subject is associated with a clinically significant cancer comprising:
- (a) obtaining or having obtained a gut microbiome-containing sample from a human subject;
- (b) performing a genetic analysis on the gut microbiome-containing sample so as to determine a (i) presence or not and (ii) abundance value of each of the following taxa:
- g_Oscillospora;
- g_Lachnospira;
- f_Corynebacteriaceae;
- g_Corynebacterium;
- o_Actinomycetales;
- f Paraprevotellaceae;
- g_Eubacterium;
- g_Peptoniphilus;
- o_Enterobacteriales;
- c_Erysipelotrichi;
- c_Gammaproteobacteria;
- g_Finegoldia;
- p_Proteobacteria,
- f Bacteroidaceae;
- and
- c_Deltaproteobacteria;
- (c) generating a numerical microbiome score from the genetic analysis performed in (b);
- (d) comparing the numerical microbiome score generated in (c) with a predetermined reference value which delineates a cutoff between (i) clinically significant cancer and (ii) low-risk cancer/negative biopsy, so as to determine if the gut microbiome sample is associated with a clinically significant cancer,
- wherein a numerical microbiome score equal to or greater than the predetermined reference value indicates the sample comes from a human subject at risk of clinically significant cancer and a numerical microbiome score less than the predetermined reference value indicates the sample comes from a human subject with low-risk of cancer/negative biopsy.
A method of detecting the presence or absence of a clinically significant cancer in a human subject, the method comprising:
- (a) obtaining or having obtained a gut microbiome-containing sample from a human subject;
- (b) performing a genetic analysis on the gut microbiome-containing sample, so as to determine a (i) presence or not and (ii) abundance value of each of the following taxa:
- g_Oscillospora;
- g_Lachnospira;
- f_Corynebacteriaceae;
- g_Corynebacterium;
- o_Actinomycetales;
- f Paraprevotellaceae;
- g_Eubacterium;
- g_Peptoniphilus;
- o_Enterobacteriales;
- c_Erysipelotrichi,
- c_Gammaproteobacteria;
- g_Finegoldia,
- p_Proteobacteria,
- f Bacteroidaceae;
- and
- c_Deltaproteobacteria;
- (c) generating a numerical microbiome score from the genetic analysis performed in (b);
- (d) detecting:
- (i) the presence of a clinically significant cancer if the numerical microbiome score generated in (c) is equal to or greater than a predetermined reference value which delineates a cutoff between clinically significant cancer and low-risk cancer/negative biopsy;
- and
- (ii) the absence of a clinically significant cancer, defined as low-risk of cancer/negative biopsy, if the numerical microbiome score generated in (c) is less than the predetermined reference value.
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Dependencies are inferred from the claim text.