Methods for the diagnosis of oncological disorders using epimetabolic shifters, multidimensional intracellular molecules, or environmental influencers

Abstract

Methods and formulations for diagnosing onocological disorders in humans using epimetabolic shifters, multidimensional intracellular molecules or environmental influencers are described.

1 . A method of identifying and treating a subject afflicted with an oncological disorder in a Coenzyme Q10 responsive state, the method comprising:
 (1) detecting the level of expression of at least one marker present in a biological sample obtained from a subject having an oncological disorder, wherein the at least one marker comprises one or more marker proteins listed in Tables 2-4 & 6-29, wherein the subject has been administered Coenzyme Q10;   (2) comparing the level of expression of the at least one marker in the biological sample to the level of expression of the at least one marker present in a control sample, wherein the control sample is a biological sample obtained from the subject prior to administration of Coenzyme Q10,
 wherein the subject is determined to be afflicted with an oncological disorder in a Coenzyme Q10 responsive state when the level of expression of the at least one marker in the biological sample is modulated relative to the level of expression of the at least one marker in the control sample and 
   (3) continuing administration of Coenzyme Q10 to a subject determined to be afflicted with an oncological disorder in a Coenzyme Q10 responsive state.   
     
     
         2 - 14 . (canceled) 
     
     
         15 . A method of identifying and treating a subject afflicted with an oncological disorder in a Coenzyme Q10 responsive state, the method comprising:
 (1) detecting the level of expression of at least one marker present in a tumor sample or component thereof obtained from a subject having an oncological disorder, wherein the tumor sample or component thereof has been exposed to Coenzyme Q10 ex vivo, and wherein the at least one marker comprises one or more marker proteins listed in Tables 2-4 & 6-29;   (2) detecting the level of expression of the at least one marker present in a control sample or component thereof obtained from the subject, wherein the control sample is a tumor sample or component thereof that has not been exposed to Coenzyme Q10;   (3) comparing the level of expression of the at least one marker in the tumor sample to the level of expression of the at least one marker present in the control sample,
 wherein the subject is determined to be afflicted with an oncological disorder in a Coenzyme Q10 responsive state, when the level of expression of the at least one marker in the biological sample is modulated relative to the level of expression of the at least one marker in the control; and 
   (4) administering Coenzyme Q10 to a subject determined to be afflicted with an oncological disorder in a Coenzyme Q10 responsive state.   
     
     
         16 - 18 . (canceled) 
     
     
         19 . The method of  claim 1 , wherein the oncological disorder is selected from the group consisting of: a leukemia, a lymphoma, a melanoma, a carcinoma and a sarcoma. 
     
     
         20 . (canceled) 
     
     
         21 . The method of  claim 1 , wherein the sample comprises a fluid obtained from the subject. 
     
     
         22 . The method of  claim 21 , wherein the fluid is selected from the group consisting of blood fluids, vomit, saliva, lymph, cystic fluid, urine, fluids collected by bronchial lavage, fluids collected by peritoneal rinsing, and gynecological fluids. 
     
     
         23 . The method of  claim 22 , wherein the sample is a blood sample or a component thereof. 
     
     
         24 . The method of  claim 1 , wherein the sample comprises a tumor tissue or component thereof obtained from the subject. 
     
     
         25 . (canceled) 
     
     
         26 . The method of  claim 1 , wherein the subject is a human. 
     
     
         27 . The method of  claim 1 , wherein the level of expression of the at least one marker in the biological sample is determined by assaying a transcribed polynucleotide or a portion thereof in the sample. 
     
     
         28 . The method of  claim 27 , wherein assaying the transcribed polynucleotide comprises amplifying the transcribed polynucleotide. 
     
     
         29 . The method of  claim 1 , wherein the level of expression of the at least one marker in the subject sample is determined by assaying a protein or a portion thereof in the sample. 
     
     
         30 . The method of  claim 1 , wherein the protein is assayed using a detection reagent which specifically binds with the protein. 
     
     
         31 . (canceled) 
     
     
         32 . The method of  claim 30 , wherein the detection reagent is selected from the group consisting of an antibody and an antigen-binding antibody fragment. 
     
     
         33 . The method of  claim 1 , wherein the level of expression of the at least one marker in the sample is determined using a technique selected from the group consisting of polymerase chain reaction (PCR) amplification reaction, reverse-transcriptase PCR analysis, single-strand conformation polymorphism analysis (SSCP), mismatch cleavage detection, heteroduplex analysis, Southern blot analysis, Northern blot analysis, in situ hybridization, array analysis, deoxyribonucleic acid sequencing, restriction fragment length polymorphism analysis, and combinations or sub-combinations thereof, of said sample. 
     
     
         34 . The method of  claim 1 , wherein the level of expression of the at least one marker in the sample is determined using a technique selected from the group consisting of Western blot analysis, immunohistochemistry, immunocytochemistry, flow cytometry, ELISA and mass spectrometry. 
     
     
         35 - 39 . (canceled) 
     
     
         40 . The method of  claim 1 , wherein the at least one marker comprises two, three, four, five, ten, twenty, thirty, forty or fifty of the marker proteins listed in Tables 2-4 & 6-29. 
     
     
         41 - 65 . (canceled) 
     
     
         66 . The method of  claim 19 , wherein the oncological disorder is an aggressive carcinoma or melanoma. 
     
     
         67 . The method of  claim 15 , wherein the oncological disorder is selected from the group consisting of: a leukemia, a lymphoma, a melanoma, a carcinoma and a sarcoma. 
     
     
         68 . The method of  claim 67 , wherein the oncological disorder is an aggressive carcinoma or melanoma. 
     
     
         69 . The method of  claim 15 , wherein the subject is a human. 
     
     
         70 . The method of  claim 15 , wherein the level of expression of the at least one marker in the tumor sample is determined by assaying a transcribed polynucleotide or a portion thereof in the sample. 
     
     
         71 . The method of  claim 70 , wherein assaying the transcribed polynucleotide comprises amplifying the transcribed polynucleotide. 
     
     
         72 . The method of  claim 15 , wherein the level of expression of the at least one marker in the subject sample is determined by assaying a protein or a portion thereof in the sample. 
     
     
         73 . The method of  claim 15 , wherein the protein is assayed using a detection reagent which specifically binds with the protein. 
     
     
         74 . The method of  claim 73 , wherein the detection reagent is selected from the group consisting of an antibody and an antigen-binding antibody fragment. 
     
     
         75 . The method of  claim 15 , wherein the level of expression of the at least one marker in the sample is determined using a technique selected from the group consisting of polymerase chain reaction (PCR) amplification reaction, reverse-transcriptase PCR analysis, single-strand conformation polymorphism analysis (SSCP), mismatch cleavage detection, heteroduplex analysis, Southern blot analysis, Northern blot analysis, in situ hybridization, array analysis, deoxyribonucleic acid sequencing, restriction fragment length polymorphism analysis, and combinations or sub-combinations thereof, of said sample. 
     
     
         76 . The method of  claim 15 , wherein the level of expression of the at least one marker in the sample is determined using a technique selected from the group consisting of Western blot analysis, immunohistochemistry, immunocytochemistry, flow cytometry, ELISA and mass spectrometry. 
     
     
         77 . The method of  claim 15 , wherein the at least one marker comprises two, three, four, five, ten, twenty, thirty, forty or fifty of the marker proteins listed in Tables 2-4 & 6-29.