Abstract: The present invention includes methods and biomarkers for diagnosing or detecting colorectal cancer metastasis in a human subject by comparing the Alu repeat methylation level in the biological sample to an Alu repeat methylation control level from a normal non-cancerous sample from the human subject, wherein a decrease in the Alu repeat methylation level is indicative of colorectal cancer and colorectal cancer metastasis.

Abstract: Embodiments provide methods and compositions related to determining treatments for colorectal cancer patients by detection and analysis of the expression level of miRNA such as miR-320e in the patients.

Abstract: Embodiments provide methods and compositions related to determining treatments for colorectal cancer patients by detection and analysis of the expression level of miRNA such as miR-320e in the patients. Embodiments provide predictive, prognostic and/or diagnostics methods by identifying miRNAs that are useful for clinical management of cancer patients, particularly colorectal cancer patients or patients at risk or determined to have colorectal cancer. Methods and compositions are based, in part, on the discovery that expression of certain miRNAs in cancer patients is associated with advancing cancer stages and/or can predict the responsiveness of cancer therapy, and can, therefore, provide basis for designing treatment strategies. In particular embodiments, the miRNA molecule is miR-320, particularly miR-320e.

Abstract: Embodiments provide methods and compositions related to detecting neoplasia in ulcerative colitis patients by detection and analysis of the methylation state of miR-1, -9, -124, miR-137 and/or miR-34b/c in samples from UC patients.

Abstract: Embodiments provide methods and compositions related to detecting neoplasia in ulcerative colitis patients by detection and analysis of the methylation state of miR-1, -9, -124, miR-137 and/or miR-34b/c in samples from UC patients.

Abstract: Methods and compositions for the diagnosis, prognosis and classification of cancer, especially colorectal cancer, are provided. For example, in certain aspects methods for cancer prognosis using expression or methylation analysis of selected biomarkers are described. Particular aspects of the present invention may include methods and biomarkers for diagnosing or detecting colorectal cancer or metastasis in a subject by measuring a level of expression of biomarker miRNA such as miR-885-5p in the sample from the subject and evaluating the risk of developing cancer or metastasis in the subject.

Abstract: Embodiments provide methods and compositions related to detecting neoplasia in ulcerative colitis patients by detection and analysis of the methylation state of miR-1, -9, -124, miR-137 and/or miR-34b/c in samples from UC patients.

Abstract: Embodiments provide methods and compositions related to determining treatments for colorectal cancer patients by detection and analysis of the expression level of miRNA such as miR-320e in the patients. Embodiments provide predictive, prognostic and/or diagnostics methods by identifying miRNAs that are useful for clinical management of cancer patients, particularly colorectal cancer patients or patients at risk or determined to have colorectal cancer. Methods and compositions are based, in part, on the discovery that expression of certain miRNAs in cancer patients is associated with advancing cancer stages and/or can predict the responsiveness of cancer therapy, and can, therefore, provide basis for designing treatment strategies. In particular embodiments, the miRNA molecule is miR-320, particularly miR-320e.

Abstract: Embodiments provide methods and compositions related to detecting neoplasia in ulcerative colitis patients by detection and analysis of the methylation state of miR-1, -9, -124, miR-137 and/or miR-34b/c in samples from UC patients.

Abstract: The present invention includes methods and biomarkers for diagnosing or detecting colorectal cancer metastasis in a human subject by comparing the Alu repeat methylation level in the biological sample to an Alu repeat methylation control level from a normal non-cancerous sample from the human subject, wherein a decrease in the Alu repeat methylation level is indicative of colorectal cancer and colorectal cancer metastasis.

Abstract: A simple, rapid, inexpensive, and promising commercial biomarker assay method for multiple diseases is described herein. The present invention detects miRNA-based biomarkers in human stool specimens. The method of the present invention amplifies miRNA directly from stool specimens without any prior miRNA extraction. Differential expression of specific microRNAs in stool of colorectal cancer CRC and adenoma patients suggest fecal microRNAs as a novel potential biomarker for colorectal neoplasia detection. The method of the present invention has diagnostic, prognostic, and therapeutic relevance for gastroenterological cancers/colorectal cancer and as well as further acquired or hereditary GI diseases.

Abstract: Methods and compositions for the diagnosis, prognosis and classification of cancer, especially colorectal cancer, are provided. For example, in certain aspects methods for cancer prognosis using expression or methylation analysis of selected biomarkers are described. Particular aspects of the present invention may include methods and biomarkers for diagnosing or detecting colorectal cancer or metastasis in a subject by measuring a level of expression of biomarker miRNA such as miR-885-5p in the sample from the subject and evaluating the risk of developing cancer or metastasis in the subject.

Abstract: Use of a CAT25 mononucleotide marker in a novel tetraplex PCR for the detection of MSH6-defective colorectal cancers (CRCs) is described herein. The tetraplex PCR of the present invention offers a facile, robust, less expensive (compared to the original pentaplex assay), highly sensitive, and specific assay for the identification of microsatellite instability (MSI) in CRCs.

Abstract: The present invention includes methods, kits and biomarkers for detecting and determining the development of colorectal cancer (CRC) metastasis based on changes in the expression pattern of one or more microRNAs (miR) or miR clusters that include the miR-200/141 family.

Abstract: The present invention includes biomarkers and methods for predicting recurrence-free survival and determination of risk for colorectal liver metastasis (LM) by determining a level of microsatellite instability at tetranucleotide repeats (EMAST) and at mono- and a dinucleotide repeat loci (MSI-L) or a SMARCA2R-LOH in colorectal cancer (CRC) patients. Results obtained indicate that stage II and III patients with MSI-M had a shorter recurrence-free survival than the rest of patients with high levels of MSI (MSI-H) or with highly stable microsatellites, and that MSI-M is an independent predictor for recurrent distant metastasis in primary stage II and III CRCs. It was found that SMARCA2R-LOH and MSI-M are found in stage IV primary CRC and LM tissues.

Abstract: A method for determining a colorectal cancer metastasis in a human subject suffering from a primary colorectal cancer (CRC) is described herein. The method of the present invention comprises the steps of: i) identifying the human subject suffering from the primary CRC, ii) obtaining one or more biological samples from the human subject, iii) detecting a methylation level of Alu, LINE-1, or both in the one or more biological samples, and iv) increasing the level of the colorectal metastatic stage in the human subject when the methylation level of Alu, LINE-1 is lower compared to a corresponding control methylation level of Alu, LINE-1.

Abstract: A method for detecting an early-onset of colorectal cancer in a human subject is disclosed herein. The method comprises the steps of: (i) identifying the human subject suspected of suffering from a colorectal cancer, (ii) obtaining one or more biological samples from the human subject; (iii) determining a LINE-1 methylation level for the one or more biological samples; and (iv) comparing the LINE-1 methylation level to a LINE-1 methylation control level, wherein a higher degree of the LINE-1 methylation level is indicative of an early-onset colorectal cancer.

Abstract: Methods for treating a patient at risk for or diagnosed with colorectal cancer are disclosed herein. The method of the present invention determines the overall expression of MSH3 in cells suspected of being colorectal cancer cells from the patient and predicting the efficacy of therapy with a genotoxic anti-neoplastic agent for treating the patient, wherein a decrease in the overall expression of MSH3 in the patient cells when compared to the expression of MSH3 in normal colorectal cells indicates a predisposition to responsiveness to genotoxic anti-neoplastic agent therapy, wherein the therapy comprises administering an effective amount of the genotoxic anti-neoplastic agent therapy to patients.

Abstract: A technique for the analysis of global miRNA signatures including a larger panel of miRNAs in various groups of well-characterized colorectal cancers (CRCs) is described in the instant invention. The results presented herein provide a large list of miRNAs that are dysregulated in CRC compared to the normal colonic tissue, and, more importantly, the present invention shows for the first time that Lynch syndrome and sporadic MSI tumors exhibit a different miRNA signature that distinguishes them.

Abstract: A simple, rapid, inexpensive, and promising commercial biomarker assay method for multiple diseases is described herein. The present invention detects miRNA-based biomarkers in human stool specimens. The method of the present invention amplifies miRNA directly from stool specimens without any prior miRNA extraction. Differential expression of specific microRNAs in stool of colorectal cancer CRC and adenoma patients suggest fecal microRNAs as a novel potential biomarker for colorectal neoplasia detection. The method of the present invention has diagnostic, prognostic, and therapeutic relevance for gastroenterological cancers/colorectal cancer and as well as further acquired or hereditary GI diseases.