Triaging of patients having asymptomatic hematuria using genotypic and phenotypic biomarkers

A gene expression, patient technology, applied in the direction of biochemical equipment and methods, biological testing, biological material analysis, etc.

Active Publication Date: 2017-02-22
PACIFIC EDGE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This solves the problem that many patients with hematuria but not bladder cancer may undergo costly and further invasive work-up for the condition that is not needed

Method used

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  • Triaging of patients having asymptomatic hematuria using genotypic and phenotypic biomarkers
  • Triaging of patients having asymptomatic hematuria using genotypic and phenotypic biomarkers
  • Triaging of patients having asymptomatic hematuria using genotypic and phenotypic biomarkers

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0128] Thus, in certain preferred embodiments, a combination of genetic and phenotypic markers is provided that allows for bladder cancer from those at sufficient risk to warrant further clinical workup, possibly including cystoscopy or other The procedure identified patients with a low probability of having bladder cancer. In other embodiments, a marker is provided that has a reliability of greater than about 70%; in other embodiments, a reliability of greater than about 73%, and in still other embodiments, a reliability of greater than about 80%, In yet further embodiments, a reliability of greater than about 90%, in still other embodiments, a reliability of greater than about 95%, and in still further embodiments, a reliability of greater than about 98%, and in In some embodiments, about 100% reliability.

[0129] For genetic analysis, the practice of the present invention will employ, unless otherwise indicated, conventional techniques of molecular biology (including reco...

example 1

[0345] Example 1: Genotype Analysis of Bladder Cancer

[0346] method

[0347] Patients: Between April 2008 and September 2009, 485 patients with macroscopic hematuria but no history of urinary tract malignancy were recruited at 11 urology clinics in New Zealand and Australia. Each patient provided a urine sample immediately before undergoing cystoscopy and any additional diagnostic procedures. Three months into the study, a diagnosis was made. Of these 485 patients, gene expression data for all five studied genes were successfully obtained for 442 patients using the method described below. The characteristics of these patients are shown in Table 4.

[0348] Table 4: Characteristics of Study Population I

[0349]

[0350]

[0351] Table 4 shows the number of patients in each major diagnostic category at three months after their first overt hematuria.

[0352] Urinalysis: Urine samples were analyzed by Central Review Cytology (Southern Community Laboratories, Dunedin...

example 2

[0420] method

[0421] research group

[0422] A series of consecutive patients without a history of TCC were prospectively recruited between 28 April 2008 and 11 August 2009 at nine urology clinics in New Zealand and two urology clinics in Australia. The patient group included the patients used in Example 1, but also included an additional 46 patients whose data were not used in the first analysis. Further research also includes further analysis of the obtained results. Sample collection and RNA collection and testing were as described in Example 1.

[0423] RNA test development

[0424] Consists of four mRNA markers CDC2, HOXA13, MDK and IGFBP5. These markers were selected based on their low expression in blood and inflammatory cells and their overexpression in TCC. In this cohort study, we prospectively assigned a linear discriminant algorithm (uRNA-D), which combines four markers into a single score. uRNA-D is independent and was developed on a previous dataset. H...

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Abstract

New methods for identifying patents with hematuria who are at low risk of having urothelial cancer (UC) include combining selected phendtypic variables with levels of genotypic expression into a new metric, the "G+P INDEX." The G+P INDEX combines age, sex, smoking history, presence of hematuria, and frequency of hematuria with genotypic expression of the genetic markers, MDK, CDC2, HOXA13, IGFBP5, and optionally IL8Rb, then determining of the G+P INDEX value obtained for a patient is within one of three groups, either: (1) at High Risk of UC, (2) at Risk of UC, or (3) at Low Risk of UC.

Description

[0001] claim priority [0002] This application claims priority to US Provisional Patent Application No. 61 / 907,013, filed November 21, 2013; inventors are David Darling, Satish Kumar, Mark Dalphin, and Paul O'Sullivan. This provisional application is fully incorporated herein by reference. technical field [0003] The present invention relates to testing patients who do not suffer from a disease. In particular, the invention relates to the use of genetic and phenotypic markers to triage patients with hematuria but without cancer. In particular, the present invention relates to the analysis of genetic and phenotypic markers in the classification of patients with macroscopic or microscopic hematuria. More particularly, the present invention relates to the combined use of genetic and phenotypic markers to classify patients with asymptomatic macroscopic or microscopic hematuria and to predict whether a patient's condition requires further clinical management. Background tech...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/574
CPCG01N33/57484G01N2800/60C12Q2600/118C12Q2600/158C12Q2600/16C12Q1/6886G01N33/50G01N33/57407
Inventor 马克·达尔芬大卫·达林詹姆斯·米勒·萨蒂莱莫尼斯·卡瓦列尔瑞斯保罗·奥沙利文萨蒂什·库马尔
Owner PACIFIC EDGE
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