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Biomarkers for bladder cancer and methods using the same

A technology for biomarkers and bladder cancer, applied in biological testing, biomaterial analysis, compound screening, etc.

Inactive Publication Date: 2014-12-10
METABOLON
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Many of these tests have good sensitivity but insufficient specificity, which would lead to too many false positive results if used in routine clinical practice

Method used

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  • Biomarkers for bladder cancer and methods using the same
  • Biomarkers for bladder cancer and methods using the same
  • Biomarkers for bladder cancer and methods using the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0152] Example 1: Biomarkers for Bladder Cancer

[0153] Biomarkers were discovered by (1) analyzing urine samples from different groups of human subjects to determine the levels of metabolites in the samples, and then (2) performing statistical analysis of the results to determine differences between the 2 groups metabolites in.

[0154] Two studies were conducted to identify biomarkers for bladder cancer. In Study 1, 10 control urine samples collected from subjects without bladder cancer and 10 urine samples from subjects with bladder cancer (urothelial transitional cell carcinoma) were analyzed . Age, race, and gender were all strictly controlled to minimize the effect of variables that confound demographic effects. All subjects were Caucasian males. The mean age of the bladder cancer cohort was 71.1, and the mean age of the control cohort was 67.7. For age, the p-value of the paired t-test analysis was 0.2, which indicated that age was not significantly different be...

Embodiment 2

[0163] Example 2. Classification of Subjects Based on Urine Biomarkers in a Statistical Model

[0164] a. BCA and non-cancer

[0165] A number of analytical methods are available to evaluate the utility of identified biomarkers for diagnosing a patient condition (eg, whether a patient has bladder cancer). Two simple methods are used below: principal component analysis and hierarchical clustering using Pearson correlation.

[0166] In one method of analysis, principal component analysis was performed to model the classification of subjects as controls (non-cancer) or bladder cancer (TCC). The data used for the principal component analysis model were obtained from the osmolarity-normalized data of the urine samples from Study 1 of Example 1 (i.e., 10 control urine samples collected from subjects without bladder cancer and 10 urine samples from subjects with bladder cancer (urothelial transitional cell carcinoma).

[0167] Using the model derived by principal component ana...

Embodiment 3

[0190] Example 3. Biomarkers for bladder cancer staging

[0191] Bladder cancer staging provides an indication of how far the bladder tumor has spread. Tumor staging is used to select treatment options and estimate a patient's prognosis. Bladder tumor stages range from T0 (no evidence of a primary tumor, the earliest stage) to T4 (the tumor has spread beyond the fat tissue surrounding the bladder into nearby organs, the latest stage). Early stages of bladder cancer can also be characterized as carcinoma in situ (CIS), which means cells that proliferate abnormally but are still contained within the bladder.

[0192] To identify biomarkers of disease stage and / or progression, 21 low-stage BCA (CIS, T0, T1) subjects, 42 high-stage BCA (T2-T4) subjects, and 89 normal subjects were tested. Urine samples from the patients were subjected to metabolome analysis. After determining the levels of metabolites, the data were analyzed using one-way ANOVA comparatively to identify bioma...

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Abstract

Methods for identifying and evaluating biochemical entities useful as biomarkers for bladder cancer, target identification / validation, and monitoring of drug efficacy are provided. Also provided are suites of small molecule entities as biomarkers for bladder cancer.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of U.S. Provisional Patent Application No. 61 / 558,688, filed November 11, 2011, and U.S. Provisional Patent Application No. 61 / 692,738, filed August 24, 2012, both of which are incorporated by reference in their entirety In this article. field of invention [0003] The present invention generally relates to biomarkers for bladder cancer and methods based on said biomarkers. Background of the invention [0004] In the United States, more than 90% of bladder cancer (BCA) cases are transitional cell carcinoma (TCC), also known as urothelial carcinoma (UC). Approximately 70% of newly diagnosed TCC / UC patients have non-muscle-invasive bladder cancer (NMIBC) tumors (ie, T0a, T1, and CIS). Management of patients with NMIBC includes enucleation of visible tumor by transurethral resection of bladder tumor (TURB-T) and active monitoring for tumor recurrence to minimize the risk of cancer pr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/53A61P35/00H01J49/26
CPCG01N2500/10G01N2800/56G01N33/57407G01N2500/00G01N2800/60G01N2800/52A61P35/00G01N30/7206G01N30/7233G01N2405/08
Inventor J.E.麦顿恩R.佩里乔恩B.內里B.维特曼恩
Owner METABOLON
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