Diagnostic, predictive and prognostic testing for cancer

Abstract

The present invention relates generally to the field of cancer. In particular, the present invention relates to cancer prognostic and treatment protocols.

1 . A method for determining a treatment protocol for a subject having cancer, the method comprising the in vitro steps of:
 a) assessing the level of a first biomarker selected from at least one of Mcm2 to 7 in a biological sample from the subject; and   b) assessing the level of a second biomarker selected from at least one of geminin, Aurora A, Plk1 and H3S10ph in a biological sample from the subject,   wherein the combination of the level of the first biomarker compared to a pre-determined value and the level of the second biomarker compared to a predetermined value is indicative of the treatment regimen prescribed for the subject.   
     
     
         2 . A method for predicting therapeutic treatment response of a subject having cancer, the method comprising the steps of:
 a) assessing a level of a first biomarker selected from at least one of Mcm2 to 7 in a biological sample from the subject; and   b) assessing the level of a second biomarker selected from at least one of geminin, Aurora A, Plk1 and H3S10ph in a biological sample from the subject;   wherein the combination of the level of the first biomarker compared to a pre-determined value and the level of the second biomarker compared to a predetermined value is indicative of the efficacy of the therapeutic treatment.   
     
     
         3 . A method for determining the progression of a cancer in a subject, comprising the in vitro steps of:
 a) assessing the level of a first biomarker selected from at least one of Mcm2 to 7 in a biological sample from the subject; and   b) assessing the level of a second biomarker selected from at least one of geminin, Aurora A, Plk1 and H3S10ph in a biological sample from the subject,   wherein the combination of the level of the first biomarker compared to a pre-determined value and the level of the second biomarker compared to a predetermined value is indicative of cancer progression in the subject.   
     
     
         4 . The method of  claim 1 , further comprising assessing the level of a third biomarker selected from at least one of geminin, Aurora A, Plk1 and
 H3S10ph in the biological sample from said subject, wherein the second and third biomarkers are different.   
     
     
         5 . The method of  claim 1 , wherein when the level of the first biomarker compared to a pre-determined value is low and the level of the second biomarker compared to a pre-determined value is low, the treatment regimen is selected from one or more of:
 a) monitoring; and   b) treatment with non-cell-cycle phase specific chemotherapeutic agents.   
     
     
         6 . The method of  claim 1 , wherein when the level of the first biomarker compared to a predetermined value is high and the level of the second biomarker compared to a pre-determined value is low, the treatment regimen is selected from one or more of:
 a) monitoring; and   b) treatment with G1 or non-cell cycle phase specific chemotherapeutic agents.   
     
     
         7 . The method of  claim 1 , wherein when the level of the first biomarker compared to a pre-determined value is high and the level of the second biomarker compared to a pre-determined value is high, the treatment regimen is treatment with S, G2 or M cell cycle phase specific chemotherapeutic agents. 
     
     
         8 . The method of  claim 1 , wherein the biological sample is selected from the group consisting of tumor biopsy tissue, whole blood, blood plasma, blood serum, cervical smears, urine, prostatic massage specimens, bronchio-lavage, sputum and brushings from the alimentary tract. 
     
     
         9 . The method of  claim 1 , wherein the level of the first and second biomarker is determined using an immunological assay method. 
     
     
         10 . The method of  claim 9 , wherein the immunological assay method is selected from the group consisting of immunohistochemistry, immunocytochemistry, dot blot analysis, slot blot analysis, RIA, peptide microarray, and ELISA. 
     
     
         11 . The method of  claim 1 , wherein the level of the first and second biomarker is determined using a molecular biological-based assay methods. 
     
     
         12 . The method of  claim 11 , wherein the molecular biological-based assay method is selected from the group consisting of Northern blot analysis, Southern blot analysis, Western blot analysis, RT-PCR, PCR, nucleic acid sequence based amplification assays (NASBA), transcription mediated amplification (TMA), or computerized detection matrix. 
     
     
         13 . The method of  claim 1 , wherein the subject has cancer selected from the group consisting of breast cancer, endometrial cancer, ovarian cancer, epithelial ovarian cancer, lung cancer, prostate cancer, kidney cancer, bladder cancer, cancer of the oral mucosa, oesophageal cancer, cancer of the lymphreticular system, brain cancer, genito-urinary cancer, skin cancer, colon cancer, stomach cancer, bladder cancer, cancer of the urethra and cancer of the aerodigestive tract. 
     
     
         14 . The method of  claim 1 , wherein the first and the second biomarker can be measured sequentially or concurrently. 
     
     
         15 . The method of  claim 1 , wherein the level of the first biomarker is measured before measuring the level of the second biomarker. 
     
     
         16 . The method of  claim 2 , further comprising assessing the level of a third biomarker selected from at least one of geminin, Aurora A, Plk1 and H3S10ph in the biological sample from said subject, wherein the second and third biomarkers are different. 
     
     
         17 . The method of  claim 3 , further comprising assessing the level of a third biomarker selected from at least one of geminin, Aurora A, Plk1 and
 H3S10ph in the biological sample from said subject, wherein the second and third biomarkers are different.   
     
     
         18 . The method of  claim 2 , wherein the subject has cancer selected from the group consisting of breast cancer, endometrial cancer, ovarian cancer, epithelial ovarian cancer, lung cancer, prostate cancer, kidney cancer, bladder cancer, cancer of the oral mucosa, oesophageal cancer, cancer of the lymphreticular system, brain cancer, genito-urinary cancer, skin cancer, colon cancer, stomach cancer, bladder cancer, cancer of the urethra and cancer of the aerodigestive tract. 
     
     
         19 . The method of  claim 3 , wherein the subject has cancer selected from the group consisting of breast cancer, endometrial cancer, ovarian cancer, epithelial ovarian cancer, lung cancer, prostate cancer, kidney cancer, bladder cancer, cancer of the oral mucosa, oesophageal cancer, cancer of the lymphreticular system, brain cancer, genito-urinary cancer, skin cancer, colon cancer, stomach cancer, bladder cancer, cancer of the urethra and cancer of the aerodigestive tract.