Grading, staging, and prognosing cancer using osteopontin-c

Patent metadata

Field	Value
Publication number	US-10934591-B2
Application number	US-201715840611-A
Country	US
Kind code	B2
Filing date	Dec 13, 2017
Priority date	Oct 16, 2007
Publication date	Mar 2, 2021
Grant date	Mar 2, 2021

Abstract

The present disclosure provides methods and kits that can be used to determine the grade or stage of a breast or other cancer, such as a ductal carcinoma in situ (DCIS). By determining the grade, stage, or aggressiveness of a cancer, appropriate therapeutic regiments can be selected and administered to the patient with the cancer. The method includes detecting osteopontin-c (OPN-c), wherein the presence of high amounts of OPN-c in the cancer sample indicates that the subject has a more aggressive form of cancer (e.g., grade 3).

First claim

We claim:

1. A kit consisting of:
(a) a nucleic acid probe or primer that specifically hybridizes to an estrogen receptor (ER) nucleic acid molecule; a nucleic acid probe or primer that specifically hybridizes to a progesterone receptor (PR) nucleic acid molecule; a nucleic acid probe or primer that specifically hybridizes to a human epidermal growth factor receptor 2 (HER2) nucleic acid molecule; and a nucleic acid probe or primer that specifically hybridizes to an OPN-c nucleic acid molecule; and/or
(b) an antibody that specifically binds estrogen receptor (ER); an antibody that specifically binds progesterone receptor (PR); an antibody that specifically binds HER2; and an antibody that specifically binds OPN-c.

2. The kit of claim 1 , wherein the nucleic acid probe or primer that specifically hybridizes to an OPN-c nucleic acid molecule consists of the nucleic acid sequences of SEQ ID NO: 5 and/or SEQ ID NO: 6.

3. The kit of claim 1 , wherein the nucleic acid probe or primer that specifically hybridizes to an estrogen receptor (ER) nucleic acid molecule specifically hybridizes under high stringency conditions to the nucleic acid set forth in GenBank Accession No. BC128574.1 or NM_007956.4,
wherein high stringency conditions comprise hybridization at about 42° C. in 5×SSC and washes performed at about 65° C.

4. The kit of claim 1 , wherein the nucleic acid probe or primer that specifically hybridizes to a progesterone receptor (PR) nucleic acid molecule specifically hybridizes under high stringency conditions to the nucleic acid set forth in GenBank Accession No. AF016381.1 or M68915.1,
wherein high stringency conditions comprise hybridization at about 42° C. in 5×SSC and washes performed at about 65° C.

5. The kit of claim 1 , wherein the nucleic acid probe or primer that specifically hybridizes to a HER2 nucleic acid molecule specifically hybridizes under high stringency conditions to the nucleic acid set forth in GenBank Accession No. NM_001005862.1 or NM_004448.2,
wherein high stringency conditions comprise hybridization at about 42° C. in 5×SSC and washes performed at about 65° C.

6. A kit consisting of:
(a) a nucleic acid probe or primer that specifically hybridizes to an estrogen receptor (ER) nucleic acid molecule; a nucleic acid probe or primer that specifically hybridizes to a progesterone receptor (PR) nucleic acid molecule; a nucleic acid probe or primer that specifically hybridizes to a human epidermal growth factor receptor 2 (HER2) nucleic acid molecule; and a nucleic acid probe or primer that specifically hybridizes to an OPN-c nucleic acid molecule; and/or
(b) an antibody that specifically binds estrogen receptor (ER); an antibody that specifically binds progesterone receptor (PR); an antibody that specifically binds HER2; and an antibody that specifically binds OPN-c,
wherein (a) and/or (b) is optionally combined with
(i) one or more control samples with known amounts of ER, PR, HER2, and OPN-c, and/or
(ii) a nucleic acid probe or primer that specifically hybridizes to a housekeeping gene or a message of a housekeeping gene; and/or an antibody that specifically binds to a protein expressed by a housekeeping gene.

7. The kit of claim 6 , wherein the nucleic acid probe or primer that specifically hybridizes to an OPN-c nucleic acid molecule consists of the nucleic acid sequences of SEQ ID NO: 5 and/or SEQ ID NO: 6.

8. The kit of claim 6 , wherein the nucleic acid probe or primer that specifically hybridizes to an estrogen receptor (ER) nucleic acid molecule specifically hybridizes under high stringency conditions to the nucleic acid set forth in GenBank Accession No. BC128574.1 or NM_007956.4,
wherein high stringency conditions comprise hybridization at about 42° C. in 5×SSC and washes performed at about 65° C.

9. The kit of claim 6 , wherein the nucleic acid probe or primer that specifically hybridizes to a progesterone receptor (PR) nucleic acid molecule specifically hybridizes under high stringency conditions to the nucleic acid set forth in GenBank Accession No. AF016381.1 or M68915.1,
wherein high stringency conditions comprise hybridization at about 42° C. in 5×SSC and washes performed at about 65° C.

10. The kit of claim 6 , wherein the nucleic acid probe or primer that specifically hybridizes to a HER2 nucleic acid molecule specifically hybridizes under high stringency conditions to the nucleic acid set forth in GenBank Accession No. NM_001005862.1 or NM_004448.2,
wherein high stringency conditions comprise hybridization at about 42° C. in 5×SSC and washes performed at about 65° C.

Assignees

• Ventana Med Syst Inc
• Univ Cincinnati

Inventors

• Mirza Mana
• Shaughnessy Elizabeth
• Hurley John K
• Vanpatten Kristie A
• Pestano Gary
• Weber Georg F

Classifications

• C12Q1/6886 Primary

  for cancer (immunoassay for cancer G01N33/575) · CPC title

• C07K16/28

  against receptors, cell surface antigens or cell surface determinants · CPC title

• C12Q2600/158

  Expression markers · CPC title

• C12Q2600/106

  Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism · CPC title

• C12N15/11

  DNA or RNA fragments; Modified forms thereof (DNA or RNA not used in recombinant technology, C07H21/00); {Non-coding nucleic acids having a biological activity} · CPC title