Biomarker for ovarian and endometrial cancer: hepcidin

• US 7,510,842 B2
• Filed: 03/10/2006
• Issued: 03/31/2009
• Est. Priority Date: 03/11/2005
• Status: Active Grant

• Current Assignee: Aspira Women's Health, Inc., Johns Hopkins University, Board of Regents of the University of Texas System (University of Texas System)
• Original Assignee: Johns Hopkins University, Board of Regents of the University of Texas System (University of Texas System), Vermillion, Inc.
• Inventors: Zhang, Zhen, Fung, Eric T., Chan, Daniel W., Bast, Robert, Podust, Valdimir, Song, Jin
• Primary Examiner(s): Yu; Misook
• Assistant Examiner(s): Halvorson; Mark
• Application Number:
  US11/373,833
• Publication Number:
  US 20070054329A1
• Time in Patent Office: 1,117 Days
• Field of Search: None
• US Class Current: 435/7.1
• CPC Class Codes: G01N 2500/00 Screening for compounds of potential therapeutic value
• CPC Class Codes: G01N 33/57442 of the uterus and endometrial
• CPC Class Codes: G01N 33/57449 of ovaries
• CPC Class Codes: G01N 33/68 involving proteins, peptides or amino acids involving lipoproteins G01N33/92
• CPC Class Codes: G01N 33/6851 Methods of protein analysis involving laser desorption ionisation mass spectrometry
• CPC Class Codes: G01N 33/74 involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors

Abstract

The present invention provides protein-based biomarkers and biomarker combinations that are useful in qualifying ovarian cancer status as well as endometrical cancer status in a patient. In particular, it has been found that hepcidin is a biomarker for both ovarian cancer and endometrial cancer and that a panel of biomarkers, including hepcidin, transthyretin and optionally other markers are useful to classify a subject sample as ovarian cancer or non-ovarian cancer. The biomarkers can be detected by SELDI mass spectrometry.

Claims

1. A method for qualifying ovarian cancer status in a subject comprising:

(a) measuring the level of hepcidin in a biological sample from the subject being screened for ovarian cancer; and

(b) correlating the measurement of an increased level of hepcidin in the biological sample from the subject as compared to the level of hepcidin in a biological sample from a healthy subject with the diagnosis of ovarian cancer.

2. The method of claim 1, wherein the level of hepcidin is measured by mass spectrometry.

3. The method of claim 2, wherein mass spectrometry is SELDI-MS.

4. The method of claim 1, wherein the level of hepcidin is measured by immunoassay.

5. The method of claim 1, wherein the sample is blood or a blood derivative.

6. The method of claim 1, wherein the sample is ovarian cyst fluid, ascites, or urine.

7. The method of claim 1, wherein the correlating is performed by executing a software classification algorithm.

8. The method of claim 1, wherein ovarian cancer is stage I or II ovarian cancer.

9. The method of claim 1, wherein the subject has been treated for ovarian cancer and the ovarian cancer is recurrence of cancer.

10. The method of claim 1, wherein non-ovarian cancer is a gynecological condition selected from benign ovarian cyst, endometriosis, uterine fibroma, breast cancer and cervical cancer.

11. The method of claim 1, further comprising:

(c) reporting the status to the subject.

12. The method of claim 1, further comprising:

recording the status on a tangible medium.

13. The method of claim 1, further comprising:

(c) managing subject treatment based on the status.

14. The method of claim 13, further comprising:

(d) measuring the level of hepcidin after subject management and correlating the measurement with disease progression.