Non-invasive cancer diagnosis

• US 9,493,839 B2
• Filed: 09/13/2013
• Issued: 11/15/2016
• Est. Priority Date: 01/31/2012
• Status: Active Grant

• Current Assignee: Ovartec GmbH
• Original Assignee: Paul Speiser
• Inventors: Speiser, Paul, Zeillinger, Robert
• Primary Examiner(s): HANEY, AMANDA MARIE
• Application Number:
  US14/027,105
• Publication Number:
  US 20140011199A1
• Time in Patent Office: 1,159 Days
• US Class Current: 1/1
• CPC Class Codes: C12Q 1/6806 Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay C12Q1/6804 takes precedence
• CPC Class Codes: C12Q 1/6886 for cancer immunoassay for cancer G01N33/574
• CPC Class Codes: C12Q 2600/154 Methylation markers
• CPC Class Codes: C12Q 2600/156 Polymorphic or mutational markers
• CPC Class Codes: C12Q 2600/158 Expression markers

Abstract

A non-invasive method for the diagnosis of adenocarcinoma or precursor lesions in a female subject and a kit for performing such diagnosis are provided. The method comprises the steps of (1) preparing epithelial cells of a sample of the subject obtained from a rinse of the uterine cavity and, optionally, the fallopian tubes, and (2) performing an analysis of the cells to determine an abnormality associated with ovarian or endometrial cancer, where the abnormality is indicative of adenocarcinoma or a precursor lesion.

Claims

1. A method for treating ovarian cancer (OC) and/or endometrial cancer (EC) in a human subject, comprising:

(a) flowing a liquid into a human subject'"'"'s uterine cavity and fallopian tubes;

(b) aspirating a liquid sample from the uterine cavity and fallopian tubes, wherein said flowing and said aspirating occur simultaneously;

(c) fractionating said liquid sample to obtain a cell fraction of epithelial cells;

(d) identifying at least one nucleotide or amino acid mutation in TP53 associated with OC or EC in said cell fraction of epithelial cells using a method selected from the group consisting of a protein binding assay, a nucleic acid hybridization assay, a nucleic acid amplification assay, and nucleotide sequencing, wherein the presence of at least one mutation in TP53 associated with OC or EC identifies OC or EC in the human subject; and

(e) treating the human subject for OC or EC prior to the onset of symptoms of OC or EC in the human subject, wherein the treatment is selected from the group consisting of surgery and chemotherapy.

2. The method of claim 1, wherein the liquid is normal saline solution (NISR).

3. The method of claim 1, wherein nucleic acid is extracted from the epithelial cells.

4. The method of claim 1, wherein a nucleic acid sequence is determined.

5. The method of claim 1, wherein the OC or EC is an intraepithelial carcinoma of the fallopian tubes or of the endometrial lining.

6. The method of claim 1, wherein immunocytochemistry or fluorescence in situ hybridization (FISH) is employed.

7. The method of claim 1, wherein the epithelial cells are serous tubal intraepithelial carcinoma cells or serous endometrial intraepithelial carcinoma cells.

8. The method of claim 1, wherein the protein binding assay is selected from the group consisting of an ELISA assay, flow cytometric analysis, a radioimmunoassay, and a Western blot assay.

9. The method of claim 1, wherein the OC or EC identified in the human subject is stage II OC or stage II EC.