Methods of screening for lung neoplasm based on stool samples containing a nucleic acid marker indicative of a neoplasm

• US 7,368,233 B2
• Filed: 12/07/2000
• Issued: 05/06/2008
• Est. Priority Date: 12/07/1999
• Status: Expired due to Term

• Current Assignee: Exact Sciences Development Company LLC (Exact Sciences Corporation), Mayo Foundation For Medical Education And Research (Mayo Clinic)
• Original Assignee: Exact Sciences Corporation, Mayo Foundation For Medical Education And Research (Mayo Clinic)
• Inventors: Shuber, Anthony P., Ahlquist, David A.
• Primary Examiner(s): Horlick; Kenneth R.
• Application Number:
  US10/149,464
• Publication Number:
  US 20040043467A1
• Time in Patent Office: 2,707 Days
• Field of Search: 435/6, 435/91.2
• US Class Current: 435/6.11
• 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 lung neoplasm in a mammal, said method comprising:

detecting a nucleic acid marker indicative of a neoplasm in a stool sample obtained from a mammal; and

,

performing an additional cancer screening technique and detecting a neoplasm present in the lung of the mammal.

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, further comprising performing an additional cancer screening technique to determine if a naso-oro-pharyngeal, esophageal, stomach, liver, bile duct, gall bladder, small intestine, or pancreas neoplasm is present in the mammal.

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 1, wherein said neoplasm-specific nucleic acid marker comprises the presence of long DNA greater than 250 base pairs in length in said stool sample in an amount greater than expected to be present in a stool sample obtained from a patient who does not have cancer.

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

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

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

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

16. The method of claim 6, 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 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.

20. The method of claim 4, wherein it is determined if is a small intestine neoplasm is present.

21. The method of claim 20, wherein said small intestine neoplasm is a duodenum neoplasm.

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

23. The method of claim 20, wherein said small intestine neoplasm is an ileum neoplasm.

24. The method of claim 4, wherein it is determined if is a pancreas neoplasm is present.

25. The method of claim 24, wherein said neoplasm-specific nucleic acid marker comprises long DNA in said stool sample in an amount greater than expected to be present in a stool sample obtained from a patient who does not have cancer, and wherein the sequence or identity of the long DNA is not in itself indicative of neoplasm.

26. The method of claim 24, wherein said method comprises determining whether said stool sample contains two or more neoplasm-specific markers.

27. A method of screening a mammal for the presence of a lung neoplasm, the method comprising:

detecting a nucleic acid marker indicative of a neoplasm in a stool sample obtained from a mammal; and

,

performing an additional cancer screening to determine whether a neoplasm is present in the lung of the mammal.

28. A method of screening a mammal for the presence of a lung neoplasm, the method comprising:

performing a cancer screening to determine whether a neoplasm is present in the lung of a mammal based on the knowledge that a nucleic acid marker indicative of a neoplasm present in a stool sample.