Screening test for large intestinal cancer

• US 4,857,457 A
• Filed: 07/24/1986
• Issued: 08/15/1989
• Est. Priority Date: 07/24/1986
• Status: Expired due to Fees

• Current Assignee: Glenn A. Jockle
• Original Assignee: Glenn A. Jockle
• Inventors: Elsayed, Alaaeldeen M., Jockle, Glenn A., Shamsuddin, Abulkalam M.
• Primary Examiner(s): Kepplinger, Esther M.
• Application Number:
  US06/889,022
• Time in Patent Office: 1,118 Days
• Field of Search: 435/7, 435/25, 435/810, 435/14, 436/501, 436/518, 436/64, 436/94, 436/533, 436/534, 436/808, 436/813, 436/827
• US Class Current: 435/7.1
• CPC Class Codes: C12Q 1/26 involving oxidoreductase
• CPC Class Codes: G01N 33/57469 involving tumor associated glycolinkage, i.e. TAG
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/975 Kit
• CPC Class Codes: Y10S 436/808 Automated or kit
• CPC Class Codes: Y10S 436/813 Cancer
• CPC Class Codes: Y10S 436/827 Lectins

Abstract

The disaccharide β-D-Gal (1->>3)-D-GalNAc, which specifically binds with peanut agglutinin (PNA) or oxidized by galactose oxidase, has been discovered in the colorectal mucus of patients with cancer or precancer. Because of the presence of β-D-Gal-(1>>3)-D-GalNAc also on neuraminidase treated erythrocytes of the ABO type, their competitive binding with PNA has been exploited to develop a hemagglutination inhibition assay. Additional methods of simple detection of this disaccharide include a latex agglutination test, enzyme-avidin-biotinylated PNA, and a galactose oxidase strip test. This rapid, simple and inexpensive assay is designed to test the presence of β-D-Gal-(1>>3)-D-GalNAc in large intestine mucus obtained by routine digital-rectal examination and has the potential for screening populations for large intestinal carcinomas.

Claims

1. A method for detecting the presence of precancer or cancer of the large intestine, which comprises:

(a) obtaining a sample of large intestinal mucus from the rectum of a patient;

(b) assaying said sample to detect the disaccharide marker beta-D-Gal(1->

3)-D-GalNAc therein; and

(c) diagnosing precancer or cancer of the large intestine based upon the presence of the disaccharide detected in the mucus.

2. A process according to claim 1 wherein the disaccharide is detected immunochemically.

3. A process according to claim 1 wherein the disscharide is detected quantitatively.

4. A process according to claim 3 wherein the disaccharide is detected by reaction with peanut agglutinin which is immobilized onto a water-insoluble support to form a complex of said disaccharide and the peanut agglutinin.

5. A process according to claim 4 wherein the complex is assayed by reaction with biotinylated peanut agglutinin.

6. A process according to claim 4 wherein the complex is detected by reacting it with avidin which is conjugated with a marker.

7. A process according to claim 1 wherein the assay is performed by use of peanut agglutin in an agglutination inhibition test.

8. A process according to claim 7 wherein the disaccharide is detected by reacting the mucus with an approximately stoichiometric amount of peanut agglutinin.

9. A process according to claim 1 wherein the disaccharide is detected by agglomeration of sensitized beads.

10. A process according to claim 1 wherein the sugar moiety of the disaccharide marker is oxidized and the oxidized sugar moiety is determined.

11. A process according to claim 10, wherein galactose oxidase is used to oxidize the sugar moiety in the mucus.

12. A process according to claim 1 wherein the mucus is absorbed onto a water-insoluble substrate.

13. A process according to claim 12, wherein the water-insoluble substrate is a protein-capturing membrane filter.

14. A process according to claim 1, wherein the mucus is preserved at room temperature for at least several days prior to assaying the sample.

15. A diagnostic kit for detecting the presence of precancer or cancer of the large intestine according to the process of claim 1, which comprises a container comprising separately package galactose oxidase, a water-insoluble support capable of absorbing said large intestinal mucus, and basic fuchsin.

16. A diagnostic kit according to claim 15, wherein the basic fuchsin is package as Schiff'"'"'s reagent.