Supracolonic aerodigestive neoplasm detection

• US 20040043467A1
• Filed: 03/18/2003
• Published: 03/04/2004
• Est. Priority Date: 12/07/1999
• Status: Active Grant

• Current Assignee: Exact Sciences Development Company LLC (Exact Sciences Corporation), Mayo Foundation For Medical Education And Research (Mayo Clinic)
• Original Assignee: Exact Sciences Corporation
• Inventors: Shuber, Anthony P., Ahlquist, David A.
• Granted Patent: US 7,368,233 B2
• Time in Patent Office: Days
• US Class Current: 435/196
• CPC Class Codes: C07K 14/47 from mammals
• CPC Class Codes: C07K 14/4746 p53
• CPC Class Codes: C07K 14/82 Translation products from oncogenes
• CPC Class Codes: C12Q 1/6886 for cancer immunoassay for cancer G01N33/574
• CPC Class Codes: C12Q 2600/156 Polymorphic or mutational markers

Abstract

The invention provides methods and materials for detecting supracolonic aerodigestive premalignant and malignant neoplasms. Specifically, the invention provides methods and materials for determining whether a stool sample from a mammal contains a neoplasm-specific marker from a neoplsm located in the supracolonic aerodigestive tissue of a mammal.

Claims

1. A method for detecting a supracolonic aerodigestive neoplasm in a mammal, said method comprising determining whether a stool sample from said mammal contains a neoplasm specific marker, wherein said marker is from said supracolonic aerodigestive neoplasm.

2. The method of claim 1, wherein said supracolonic aerodigestive neoplasm comprises a premalignant neoplasm.

3. The method of claim 1, wherein said aerodigestive neoplasm comprises a malignant neoplasm.

4. The method of claim 1, wherein said supracolonic aerodigestive neoplasm is selected from the group consisting of lung, naso-oro-pharyngeal, esophageal, stomach, liver, bile duct, gall bladder, small intestine, and pancreas neoplasms.

5. The method of claim 1, wherein said mammal is a human.

6. The method of claim 1, wherein said neoplasm-specific marker comprises a neoplasm-specific nucleic acid marker.

7. The method of claim 6, wherein said neoplasm-specific nucleic acid marker comprises nucleic acid having a point mutation.

8. The method of claim 7, wherein said point mutation is located in a gene selected from the group consisting of K-ras, APC, and p53.

9. The method of claim 6, wherein said neoplasm-specific nucleic acid marker comprises nucleic acid that reflects microsatellite instability.

10. The method of claim 9, wherein said microsatellite instability is located in the BAT-26 gene.

11. The method of claim 6, wherein said neoplasm-specific nucleic acid marker comprises long DNA.

12. The method of claim 11, wherein said long DNA comprises DNA greater than about 300 base pairs in length.

13. The method of claim 11, wherein said long DNA comprises DNA greater than about 400 base pairs in length.

14. The method of claim 11, wherein said long DNA comprises DNA greater than about 500 base pairs in length.

15. The method of claim 11, wherein said long DNA comprises DNA greater than about 1000 base pairs in length.

16. The method of claim 1, wherein said neoplasm-specific marker comprises a neoplasm-specific polypeptide marker.

17. The method of claim 1, wherein said neoplasm-specific marker comprises a neoplasm-specific cell marker.

18. The method of claim 1, wherein said method comprises determining whether said stool sample contains two or more neoplasm-specific markers.

19. The method of claim 18, wherein said two or more neoplasm-specific markers are selected from the group consisting of nucleic acid markers, polypeptide markers, and cell markers.

20. The method of claim 18, wherein said two or more neoplasm-specific markers are neoplasm-specific nucleic acid markers.

21. The method of claim 20, wherein said two or more neoplasm-specific nucleic acid markers are selected from the group consisting of nucleic acid having a point mutation, nucleic acid that reflects microsatellite instability, and long DNA.

22. The method of claim 20, wherein said supracolonic aerodigestive neoplasm is a small intestine neoplasm.

23. The method of claim 22, wherein said small intestine neoplasm is a duodenum neoplasm.

24. The method of claim 22, wherein said small intestine neoplasm is a jejunum neoplasm.

25. The method of claim 22, wherein said small intestine neoplasm is an ileum neoplasm.

26. The method of claim 1, wherein said supracolonic aerodigestive neoplasm is a pancreas neoplasm.

27. The method of claim 26, wherein said neoplasm-specific marker comprises long DNA.

28. The method of claim 26, wherein said method comprises determining whether said stool sample contains two or more neoplasm-specific markers.

29. A method for detecting a supracolonic aerodigestive neoplasm in a mammal, said method comprising determining whether a stool sample from said mammal contains long DNA, said long DNA being from said supracolonic aerodigestive neoplasm.