Baylor Research Institute

C Richard Boland

Ajay Goel

Yuji Toiyama

Yoshinaga Okugawa

Keun Hur

Lucia Perez-Carbonell

Alexander Link

Francesc Balaguer

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. The invention also includes methods and biomarkers for diagnosing or detecting colorectal cancer (CRC) metastasis in a human subject by determining a level of expression of let-7i, miR-10b, miR-320a, and miR-221 in the sample from the one or more biological samples; and comparing the level of expression of let-7i, miR-10b, miR-320a, and miR-221 in the sample with the level of expression of let-7i, miR-10b, miR-320a, and miR-221 from normal colorectal tissue, wherein high expression of at least on of let-7i or miR-320a is indicative of a good prognosis for the CRC, while the low expression of at least one of miR-10b or miR-221 is indicative of a good prognosis for the CRC or CRC metastasis.

Identification of metastasis-specific miRNA and hypomethylation signatures in human colorectal cancer

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.

MiR-320e and colorectal cancer

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.

Ulcerative colitis (UC)-associated colorectal neoplasia markers

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.

Tissue and blood-based miRNA biomarkers for the diagnosis, prognosis and metastasis-predictive potential in colorectal cancer

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.

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Dallas, TX, United States of America

C Richard Boland