Methods of Detecting Ovarian Cancer

• US 20080286199A1
• Filed: 02/16/2006
• Published: 11/20/2008
• Est. Priority Date: 02/16/2005
• Status: Active Grant

• Current Assignee: Dana-Farber Cancer Institute
• Original Assignee: Dana-Farber Cancer Institute
• Inventors: Livingston, David M., Drapkin, Ronny
• Granted Patent: US 8,486,648 B2
• Time in Patent Office: Days
• US Class Current: 424/1.49
• CPC Class Codes: G01N 33/57411 of cervix
• CPC Class Codes: G01N 33/57442 of the uterus and endometrial
• CPC Class Codes: G01N 33/57449 of ovaries
• CPC Class Codes: Y10T 436/25 including sample preparation

Abstract

The present invention provides methods of detecting ovarian cancer using biomarkers.

Claims

1. A method for facilitating the diagnosis of a subject for a cancer of mullerian origin, comprising detecting a presence or an absence of an Elafin polypeptide in a sample from said subject, wherein the presence of said Elafin polypeptide indicates of the presence of a cancer of mullerian origin in said subject.

2. The method of claim 1, wherein said cancer is ovarian cancer, endocervical cancer, fallopian cancer, or uterine cancer.

3. The method of claim 2, wherein said ovarian cancer is serous type, endometrioid type, mucinous type, clear cell type, or transitional type.

4. The method of claim 1, wherein said subject has previously been treated surgically or hormonally for said cancer.

5. The method of claim 1, wherein said subject is BRAC1 or BRAC2 positive.

6. The method of claim 1, wherein the Elafin polypeptide has a molecular weight of approximately 12.3 kDa.

7. The method of claim 1, wherein the Elafin polypeptide has a molecular weight of approximately 9.9 kDa.

8. The method of claim 1, wherein the Elafin polypeptide has a molecular weight of approximately 6.0 kDa.

9. A method according to claim 1, wherein said sample is serum, blood plasma, ascites fluid, urine, vaginal secretion, or tissue biopsy.

10. The method of claim 1, wherein the Elafin polypeptide is detected electrophoretically, or immunochemically.

11. The method of claim 10, wherein said immunochemical detection is by radio-immune assay, immunofluorescence assay or by an enzyme-linked immunosorbant assay.

12. A method according to claim 1, further comprising detecting the presence of HE4, SLPI or CA-125 in said subject.

13. A method according to claim 1, wherein said subject has not been previously diagnosed as carrying cancer.

14. A method according to claim 1, wherein said subject has been previously diagnosed as having cancer.

15. A method for monitoring the progression of a mullerian derived cancer in a patient, comprising

a) detecting the presence of an Elafin polypeptide in a first sample from said patient at a first period of time,

b) detecting the presence of the Elafin polypeptide in a second sample from said patient at a second period of time

c) comparing the amount of polypeptide detected in step (a) to the amount detected in step (b),

wherein the cancer is progressing if the amount of the polypeptide increases over time, whereas the cancer is not progressing if the amount of the polypeptide remains constant or decreases over time.

16. The method of claim 15, wherein said cancer is ovarian cancer, endocervical cancer, fallopian cancer, or uterine cancer.

17. The method of claim 16, wherein said ovarian cancer is serous type, endometrioid type, mucinous type, clear cell type, or transitional type.

18. The method of claim 15, wherein said patient has previously been treated surgically or hormonally for said cancer.

19. The method of claim 15, wherein said first sample is taken from said patient prior to being treated for said cancer.

20. The method of claim 15, wherein said second sample is taken from said patient after being treated for said cancer.

21. A method according to claim 15, wherein said sample is serum, blood plasma, ascites fluid, urine, vaginal secretion, or tissue biopsy.

22. A method according to claim 15, further comprising detecting the presence of HE4, SLPI or CA-125 in said patient.

23. A method of diagnosing a mullerian derived cancer in a subject comprising:

detecting the presence of an Elafin polypeptide in a sample from the subject;

determining the level of the Elafin polypeptide in said sample to provide a test value; and

comparing the test value to a standard value, wherein a test value above the standard value is indicative of a mullerian derived cancer.

24. The method of claim 23, wherein said test value is 2 fold higher than said standard value.

25. The method of claim 23, wherein said test value is 5 fold higher than said standard value.

26. The method of claim 23, wherein said test value is 10 fold higher than said standard value.

27. A method according to claim 23, wherein said sample is serum, blood plasma, ascites fluid, urine, vaginal secretion, or tissue biopsy.

28. A method according to claim 23, further comprising detecting the presence of HE4, SLPI or CA-125 in said patient.

29. A method of screening for the presence of ovarian cancer in a subject, comprising contacting a sample taken from said subject with an anti-Elafin antibody under conditions permitting said antibody to specifically bind an antigen in the sample to form an antibody-antigen complex;

and

determining the amount of antibody-antigen complex in the sample as a measure of the amount of antigen in the sample, wherein an elevated level of the antigen in the sample indicates the presence of ovarian cancer.

30. The method of claim 29, wherein said subject has previously been treated surgically or hormonally for said cancer.

31. A method according to claim 29, wherein said sample is serum, blood plasma, ascites fluid, urine, vaginal secretion, or tissue biopsy.

32. The method of claim 29, wherein said subject is BRAC1 or BRAC2 positive.

33. A method according to claim 29, further comprising detecting the presence of HE4, SLPI or CA-125 in said sample.

34. A method of alleviating a symptom of a mullerian-derived tumor comprising administering to a subject in need thereof an anti-Elafin antibody linked to a toxin.

35. The method of claim 34, wherein said toxin is a chemotherapeutic agent, a radionuclide, a ricin A chain polypeptide, a cholera toxin polypeptide, or a pertussis toxin polypeptide.

36. A kit comprising in one or more containers, an Elafin antibody, a detection reagent and instructions.