Methods of screening and diagnosing esophageal cancer by determining guanylin cyclase C expression

• US 6,767,704 B2
• Filed: 03/27/2001
• Issued: 07/27/2004
• Est. Priority Date: 03/27/2000
• Status: Expired due to Term

• Current Assignee: Thomas Jefferson University (Main Line Health System)
• Original Assignee: Thomas Jefferson University (Main Line Health System)
• Inventors: Waldman, Scott A., Park, Jason, Schulz, Stephanie
• Primary Examiner(s): Myers, Carla J.
• Assistant Examiner(s): Spiegler, Alexander H.
• Application Number:
  US09/819,249
• Publication Number:
  US 20010029019A1
• Time in Patent Office: 1,218 Days
• Field of Search: 435/4, 435/6, 435/7.1, 435/91.1, 435/91.2, 435/91.51, 530/300, 530/350, 530/387.1, 536/23.1, 536/23.5, 536/24.3, 536/24.33
• US Class Current: 435/6.14
• CPC Class Codes: A61K 31/7034 attached to a carbocyclic compound, e.g. phloridzin
• CPC Class Codes: A61K 31/7048 having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin , digitoxin or digoxin
• CPC Class Codes: A61K 39/001102 Receptors, cell surface antigens or cell surface determinants
• CPC Class Codes: A61K 47/6871 the antibody targeting an enzyme
• CPC Class Codes: A61K 51/1075 the antibody being against an enzyme
• CPC Class Codes: A61K 9/127 Liposomes
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 35/04 specific for metastasis
• CPC Class Codes: A61P 37/04 Immunostimulants
• CPC Class Codes: C07K 16/3046 Stomach, Intestines
• CPC Class Codes: C07K 16/40 against enzymes
• CPC Class Codes: C12N 15/113 Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing when used in plants C12N15/8218
• CPC Class Codes: C12Q 1/6886 for cancer immunoassay for cancer G01N33/574
• CPC Class Codes: C12Q 2600/158 Expression markers
• CPC Class Codes: G01N 2333/988 Lyases (4.), e.g. aldolases, heparinase, enolases, fumarase
• CPC Class Codes: G01N 33/57407 Specifically defined cancers
• CPC Class Codes: G01N 33/57419 of colon
• CPC Class Codes: G01N 33/57446 of stomach or intestine

Abstract

Screening and diagnostic reagents, kits and methods for primary and/or metastatic stomach or esophageal cancer are disclosed. Compositions for and methods of imaging and treating primary and/or metastatic stomach or esophageal cancer are disclosed. Vaccines compositions and methods of for treating and preventing primary and/or metastatic stomach or esophageal cancer are disclosed.

Claims

1. An in vitro method of screening an individual who is suspected of having primary and/or metastatic esophageal cancer for primary and/or metastatic esophageal cancer cells comprising the steps of examining a sample of extraintestinal tissue and/or body fluids from said individual to determine whether guanylin cyclase C is being expressed by cells in said sample wherein expression of guanylin cyclase C indicates the presence of primary and/or metastatic esophageal cancer cells in said sample.

2. The method of claim 1 wherein expression of said guanylin cyclase C by said cells is determined by detecting the presence of guanylin cyclase C gene transcription product.

3. The method of claim 1 wherein expression of said guanylin cyclase C by said cells is determined by polymerase chain reaction wherein said sample is contacted with primers that selectively amplify guanylin cyclase C gene transcript or cDNA generated therefrom.

4. The method of claim 1 wherein expression of said guanylin cyclase C by said cells is determined by immunoassay wherein said sample is contacted with antibodies that specifically bind to guanylin cyclase C gene translation product.

5. The method of claim 1 wherein said sample is body fluid.

6. The method of claim 1 wherein said sample is blood.

7. The method of claim 1 wherein said sample is lymphatic tissue and/or fluid.

8. The method of claim 1 wherein said sample is a lymph node sample.

9. The method of claim 1 wherein the individual has previously been diagnosed with having esophageal cancer.

10. The method of claim 1 wherein the individual has previously been diagnosed with and treated for esophageal cancer.

12. The method of claim 10 comprising the steps of examining a sample of extraintestinal tissue and/or body fluids from an individual to determine whether guanylin cyclase C gene transcription product is present in said sample.

13. The method of claim 12 wherein the presence of guanylin cyclase C gene transcription product is determined by polymerase chain reaction wherein said sample is contacted with primers that selectively amplify guanylin cyclase C gene transcript or cDNA generated therefrom.

29. The method of claim 1 wherein expression of said guanylin cyclase C by said cells is determined by detecting guanylin cyclase C gene translation product in said sample.

11. An in vitro method of screening an individual suspected of having primary and/or metastatic esophageal cancer for the presence of primary and/or metastatic esophageal cancer cells comprising the steps of examining a sample of extraintestinal tissue and/or body fluids from said individual to determine whether guanylin cyclase C gene transcription or translation product is present in said sample wherein presence of guanylin cyclase C gene transcription and translation products indicate the presence of primary and/or metastatic esophageal cancer cells in said sample.

14. The method of claim 11 wherein the presence of guanylin cyclase C gene translation product is determined by immunoassay wherein said sample is contacted with antibodies that specifically bind to guanylin cyclase C gene translation product.

15. The method of claim 11 wherein said sample is body fluid.

16. The method of claim 11 wherein said sample is blood.

17. The method of claim 11 wherein said sample is lymphatic tissue and/or fluid.

18. The method of claim 11 wherein said sample is a lymph node sample.

19. The method of claim 11 wherein the individual has previously been diagnosed with having esophageal cancer.

20. The method of claim 11 wherein the individual has previously been diagnosed with and treated for esophageal cancer.

30. The method of claim 11 wherein the presence of guanylin cyclase C gene translation product in said sample is detected.

21. An in vitro method of confirming that a tumor cell removed from a patient suspected of having esophageal cancer cells is a esophageal tumor cell comprising the step of determining whether said tumor cell expresses guanylin cyclase C wherein expression of guanylin cyclase C indicates that the tumor cell is a esophageal tumor cell.

22. The method of claim 21 wherein expression of guanylin cyclase C by said tumor cell is determined by detecting the presence of guanylin cyclase C gene transcription product.

23. The method of claim 21 wherein expression of guanylin cyclase C by said tumor cell is determined by polymerase chain reaction wherein mRNA from said tumor cell or cDNA generated therefrom is contacted with primers that selectively amplify guanylin cyclase C gene transcript or cDNA generated therefrom.

24. The method of claim 21 wherein expression of guanylin cyclase C by said tumor cell is determined by immunoassay wherein protein from said tumor cell is contacted with antibodies that specifically bind to guanylin cyclase C gene translation product.

25. A method of diagnosing an individual who has esophageal cancer comprising the steps of examining a sample of esophagus tissue to detect the presence of guanylin cyclase C transcript or translation product wherein the presence of guanylin cyclase C transcript or translation product in said sample indicates esophageal cancer.

26. The method of claim 25 comprising the steps of examining said sample of esophageal tissue to determine whether guanylin cyclase C gene transcription product is present in said sample.

27. The method of claim 26 wherein the presence of guanylin cyclase C gene transcription product is determined by polymerase chain reaction wherein said sample is contacted with primers that selectively amplify guanylin cyclase C gene transcript or cDNA generated therefrom.

28. The method of claim 25 wherein the presence of guanylin cyclase C gene translation product is determined by immunoassay wherein said sample is contacted with antibodies that specifically bind to guanylin cyclase C gene translation product.