Method for detecting, screening, and/or monitoring cancer in an individual

Abstract

The invention relates to a method for screening and/or detecting and/or monitoring a cancer in an individual, said method comprising determining a first parameter represented by the concentration of TIMP-1 in at least one excreta, e.g. saliva, from the individual. The invention provides a method that without the need to use a blood sample is suitable for facilitating the early diagnosis of a cancer, monitoring the recurrence of a cancer, and/or monitoring the status of a cancer or the effect of cancer treatment in an individual.

1 . A method for detecting and/or screening and/or monitoring a cancer in an individual, said method comprising determining a first parameter represented by the combination of the concentration of total TIMP-1 and the concentration of free TIMP-1 in a saliva sample from the individual, wherein the presence of the first parameter above a predetermined discrimination value is an indication that the individual has a high likelihood of either having a cancer or progression in a cancer. 
     
     
         2 . A method according to  claim 1  wherein the cancer is selected from the group consisting of breast carcinoma, prostate carcinoma, colorectal carcinoma, cervical carcinoma, ovarian carcinoma, lung carcinoma, pancreatic carcinoma, renal carcinoma, vulvar carcinoma, and hepatocellular carcinoma, minimal residual disease and recurrent cancer. 
     
     
         3 - 5 . (canceled) 
     
     
         6 . A method according to  claim 1 , wherein the combination is performed by logistic regression analysis. 
     
     
         7 . A method according to  claim 1 , wherein the discrimination value is determined by determining the total concentration of TIMP-1 in the at least one excreta in both a healthy control population and a population with known cancer, thereby determining the discrimination value which identifies the cancer population with a predetermined specificity or a predetermined sensitivity. 
     
     
         8 . A method according to  claim 1 , wherein the method further comprises determining at least one second parameter representing the concentration of a marker for cancer different from any form of TIMP-1, in an excreta from an individual. 
     
     
         9 . A method according to  claim 8 , wherein the first and second parameter are combined to result in a combined parameter wherein the presence of a concentration of the combined parameter above a predetermined discrimination value is an indication that the individual has a high likelihood of having a cancer or that there is a progression in a cancer. 
     
     
         10 . A method according to  claim 9 , wherein the predetermined discrimination value is determined by determining the combined parameter in the at least one excreta in both a healthy control population and a population with known colorectal cancer, thereby determining the predetermined discrimination value which identifies the cancer population with a predetermined specificity or a predetermined sensitivity. 
     
     
         11 . A method according to  claim 9 , wherein the combination of the first and second parameter is performed by logistic regression analysis. 
     
     
         12 . A method according to  claim 8 , wherein the at least one second parameter is the concentration of Carcino Embryonic Antigen (CEA). 
     
     
         13 . A method according to  claim 7 , wherein the determination of the total concentration of TIMP-1 is performed by means of an immunoassay or an active assay. 
     
     
         14 . A method according to  claim 13 , wherein the immunoassay is an ELISA. 
     
     
         15 . A method according to  claim 13 , wherein the active assay is zymography. 
     
     
         16 . A method according to  claim 1 , which detects early stage cancer. 
     
     
         17 . A method according to  claim 16 , which detects early stage colorectal cancer. 
     
     
         18 . A method according to  claim 16 , which detects metastatic breast cancer. 
     
     
         19 . A method according to  claim 1 , which monitors the response to cancer treatment. 
     
     
         20 . A method according to  claim 1 , which monitors the recurrence of a cancer. 
     
     
         21 . A dipstick for performing the method according to  claim 1 , wherein said dipstick comprises a first colour indication zone, comprising antibodies specific for TIMP-1. 
     
     
         22 . A dipstick according to  claim 21 , wherein the first zone further comprises at least one reagent which gives an optically visible colour change in the zone dependent on the concentration of TIMP-1 in at least one excreta. 
     
     
         23 . A dipstick according to  claim 21 , wherein the dipstick further comprises a second colour indication zone, able to react with at least one substance normally present in the excreta, and thereby providing an optically visible colour change in the zone for controlling proper use of the dipstick. 
     
     
         24 . A dipstick according to  claim 23 , wherein said dipstick further comprises a third colour indication zone, comprising antibodies specific for CEA. 
     
     
         25 . A dipstick according to  claim 24 , wherein the first zone further comprises at least one reagent which can give an optically visible colour change in the zone dependent on the concentration of CEA in at least one excreta. 
     
     
         26 . A method according to  claim 1  wherein the cancer comprises breast carcinoma, prostate carcinoma, cervical carcinoma, ovarian carcinoma, lung carcinoma, pancreatic carcinoma, renal carcinoma, vulvar carcinoma, hepatocellulæar carcinoma, minimal residual disease or recurrent cancer. 
     
     
         27 . A method for detecting and/or screening and/or monitoring a cancer in an individual, said method comprising determining a first parameter represented by the combination of the concentration of total TIMP-1 and the concentration of free TIMP-1 in a saliva sample from the individual, wherein the presence of the first parameter above a predetermined discrimination value is an indication that the individual has a high likelihood of either having a cancer or progression in a cancer, and wherein the individual is selected from a population already identified as having an increased risk of developing cancer. 
     
     
         28 . A method according to  claim 27 , wherein the population includes individuals with a genetic disposition, individuals who have been exposed to carcinogenic substances, or individuals with cancer-predisposing non-malignant diseases. 
     
     
         29 . A method according to  claim 27 , wherein the individual is an individual with a prior polyp, an individual with Crohn's disease or ulcerative colitis, an individual with one or more family members with colorectal cancer, or an individual with a prior resection of an early colorectal cancer. 
     
     
         30 . A dipstick according to  claim 21 , which is based on the RIA detection principle or on an enzymatic assay detection principle.