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Development of a better screening test for bowel cancer.


ABSTRACT: Interventions: Colorectal cancer (CRC) is the second leading cause of death from cancer despite the fact that the disease is curable when detected in its early stages. Furthermore, CRC is preventable by a number of methods which include adenoma detection and removal Studies of faecal occult blood testing have demonstrated that annual screening with such tests leads to a reduction in mortality Studies clearly show that screening can also lower cancer incidence through the early detection and removal of precancerous polyps including adenomas. Based on this evidence, to effectively decrease incidence at the population level, we need to identify and remove adenomas. The current methods for identifying people likely to have adenomas are largely ad hoc and limited. Conversely, a sensitive and specific marker with strong positive predictive value for colorectal adenomas would provide an effective selection process for individuals to undergo colonoscopy, and polypectomy when an adenoma is found. The literature now describes a number of molecular characteristics of adenomas that may be useful in this setting but none of these has been explored for its value in blood or faeces. In addition, preliminary molecular studies here at Flinders University using materials from the tissue bank have identified approximately 67 genes that show promise differentiating adenomas from normal tissue. We now have a need to establish a clinical bank of relevant target clinical materials (specifically faeces and blood), that would allow us to determine the presence of these markers in faeces and blood and to relate them to the neoplastic status of patients. Phase 1 research and research by others has identified several colorectal neoplasia-associated biomarkers in Primary outcome(s): To evaluate the accuracy of a panel of blood-based candidate biomarkers for detection of screen-relevant colorectal neoplasia, relative findings at colonoscopy, a commercial blood based test for CRC and to a proven faecal occult blood test (FOBT).[two years];The goal/objective is: To develop a more accurate screening test for CRC. The aim is to determine whether a blood based gene test is as accurate as an FOBT in determining whether a person is at high risk of having curable CRC or advanced adenoma, relative to colonoscopy as the gold standard There are specific aims relating to each of the potential new marker ie is SEPT9 as accurate as FIT. The primary outcomes are the specific measurement used. These will be the levels of gene expression in each genetic marker in the panel of markers and the haemoglobin level in the FOBT. Relative accuracy is determined by comparison of each of the blood based genetic markers and the FOBT result versus colonoscopy[two years];Phase 2b) To determine whether there is potential for recurrent cancers to be detected earlier with the new biomarker panel than the currently available blood tests (such as CEA). [Two years] Study Design: Purpose: Screening;Duration: Cross-sectional;Selection: Defined population;Timing: Prospective

DISEASE(S): Colorectal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)

PROVIDER: 2456781 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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