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Characterizing prostate cancer

A technology for prostate cancer and prostate, applied in the field of methylation gene inspection, can solve problems such as small use

Inactive Publication Date: 2008-07-16
VERIDEX LCC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Use of this marker is helpful in diagnostic applications but not conclusive, and the marker is of little prognostic use

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0163] Example 1: Methylation Test and Gleason Score

[0164]Prostate samples were obtained from patients with known clinical outcomes. The Gleason score of the samples was determined according to known methods. According to these samples, the Gleason score of 52 samples was less than 7, the Gleason score of 36 samples was 7, and the Gleason score of 12 samples was greater than 7.

[0165] Methylation analysis was performed on each group using GSTP1 (Seq. ID No. 19, 20) and APC (Seq. ID No. 34, 35).

[0166] Methylation analysis was performed as follows. Genomic DNA was modified using a commercial sodium bisulfite transformation kit (Zymo Research, Orange, CA, USA). This treatment converts all cytosines in unmethylated DNA to uracil, while in methylated DNA only cytosines that are not in front of guanine are converted to uracil. All cytosines that precede guanines (in CpG dinucleotides) are still cytosines.

[0167] Sodium bisulfite-modified genomic DNA (100ng~150ng) was ...

Embodiment 2

[0177] Example 2: Serum Analysis

[0178] Serum samples were obtained from patients with known prostate cancer findings and from patients from whom biopsies were taken and Gleason scores were cited. Among these samples, 55 samples were from patients without cancer, 36 samples were from patients with Gleason score 5-6, and 21 samples were from patients with Gleason score 7-8.

[0179] The methylation status was determined according to the method in Example 1.

[0180] GSTP1 Marker was able to correctly detect methylation in 26% of samples from patients with Gleason score 7-8, and did not detect methylation in patients with Gleason score 5-6 or patients without cancer. Basicization. APC Marker was able to correctly detect methylation in 26% of samples from patients with Gleason score 7-8, and in up to 9 cases it also detected patients with Gleason score 5-6 or without cancer methylation in patients. The combined specificity of the two markers was 84%, the sensitivity was 18%...

Embodiment 3

[0206] Example 3: Urinalysis

[0207] Urine samples were obtained from patients with known prostate cancer findings and from patients from whom biopsies were taken and Gleason scores were cited. Among these samples, 42 samples were from patients with Gleason score 4-6 and 10 samples were from patients with Gleason score 7-9.

[0208] The methylation status was determined according to the method in Example 1 using Cepheid's Smart Cycler PCR equipment.

[0209] The combined specificity of the two markers, GSTP1 and RARb2, was 89% for post-massage urine samples and 91% for post-biopsy samples. The sensitivity of the methylation assay for post-massage samples was 40% in samples with Gleason scores below 7 and 78% in those samples with scores above 7. Thus, non-invasive sampling can be used in conjunction with other aspects of the invention.

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Abstract

The invention relates to identify prostate cancer. The invention provides a method for predicting the recurrence or aggressiveness of prostate cancer, comprising a) determining the Gleason score of a prostate sample, and b) determining the methylation status of a Marker in a biological sample for those patients having a Gleason score of 7 or greater; wherein methylation that exceeds a pre-determined value is indicative of an aggressive or recurrent cancer and methylation that does not exceed such pre-determined value is indicative of indolent cancer. The invention also provides a kit used for predicting the course or aggressiveness of the prostate cancer, which comprising nucleic acid amplification test reagent and a synopsis which instructs the patients having the Gleason score of 7 or greater in the use of the reagent.

Description

technical field [0001] The present invention relates to the examination of methylated genes consistent with other diagnostic methods and kits for use in these methods. Background technique [0002] In higher eukaryotes, DNA is methylated only at the 5' cytosine relative to guanine in CpG dinucleotides. This modification has important regulatory effects on gene expression, especially when it involves CpG-rich regions (CpG islands) located in gene promoter regions. Aberrant methylation of normally unmethylated CpG islands is a common event in immortalized and transformed cells and is associated with the transcriptional inactivation of specific tumor suppressor genes or other genes implicated in the progression of specific human cancers. [0003] Glutathione S-transferases (GSTs) are exemplary proteins for which the methylation status of the genes expressing them has important prognostic and diagnostic value for prostate cancer. The protein catalyzes intracellular detoxificat...

Claims

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Application Information

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IPC IPC(8): C12Q1/68
CPCG01N33/57434C12Q1/6886C12Q2600/112C12Q2600/118C12Q2600/154G01N33/49
Inventor H·王S·瓦德D·乔达里J·梅罗特拉T·维纳A·马祖姆达
Owner VERIDEX LCC
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