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US 8,617,809 B2Granted
Neoplasia screening compositions and methods of use
AssigneeThe Johns Hopkins University
InventorDavid Sidransky
Life of this patent
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Abstract
As described in more detail below, the present invention generally features compositions and non-invasive methods useful for the screening, identification, monitoring, or diagnosis of subjects having a neoplasia. The invention further provides highly accurate non-invasive methods for the staging or selection of treatment for a bladder, renal, or prostate cancer in a subject.
Claims6
A method for identifying a human subject as having a bladder neoplasia, the method comprising:
- a) obtaining DNA from a first bladder tissue sample from said human subject,
- b) performing bisulfite modification to the DNA in a);
- c) performing quantitative real-time methylation specific PCR (QMSP) on bisulfite modified DNA from the first sample using the PCR primers and probe specific for the promoter region of genes of interest, wherein the genes of interest comprise p16, ARF, MGMT, and GSTP1, and the PCR primers and probe for the promoter region of the genes of interest consist of SEQ ID NOs:
- 3, 5, 6, 7, 13, 23, 25, 26, and 27;
- d) determining the promoter methylation level of the promoter regions of the genes of interest in the DNA from the first bladder tissue sample of the subject,
- e) providing a reference non-neoplastic bladder tissue sample;
- f) comparing the level of methylation of the promoter region of the genes of interest from the first bladder tissue sample of the subject, to the level of methylation of the promoter region of the genes of interest in the reference non-neoplastic bladder tissue sample;
- and
- g) identifying said human subject as having a bladder neoplasia when the level of methylation of the promoter region of the genes of interest in the first bladder tissue sample of the subject, is increased relative to the level of methylation of the promoter region of the genes of interest in the reference non-neoplastic bladder tissue sample.
6 more elements
A method for identifying a human subject as having a bladder neoplasia, the method comprising:
- a) obtaining DNA from a first urine sample from said human subject,
- b) performing bisulfite modification to the DNA in a);
- c) performing quantitative real-time methylation specific PCR (QMSP) on bisulfite modified DNA from the first sample using the PCR primers and probe specific for the promoter region of genes of interest, wherein the genes of interest comprise p16, ARF, MGMT, and GSTP1, and the PCR primers and probe for the promoter region of the genes of interest consist of SEQ ID NOs:
- 3, 5, 6, 7, 13, 23, 25, 26, and 27;
- d) determining the promoter methylation level of the promoter regions of the genes of interest in the DNA from the first urine sample of the subject,
- e) providing a reference non-neoplastic urine sample;
- f) comparing the level of methylation of the promoter region of the genes of interest from the first urine sample of the subject, to the level of methylation of the promoter region of the genes of interest in the reference non-neoplastic urine sample;
- and
- g) identifying said human subject as having a bladder neoplasia when the level of methylation of the promoter region of the genes of interest in the first urine sample of the subject, is increased relative to the level of methylation of the promoter region of the genes of interest in the reference non-neoplastic urine sample.
6 more elements
Dependencies are inferred from the claim text.