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Validation of an Alternative Biological Test to Increase the Detection Sensitivity of a Colon Tumour

ABSTRACT: Screening campaigns for colorectal cancer (CRC) involve two steps: the detection of occult blood in stools using a Hemoccult GAIAC test (FOBT) on three consecutive stool samples, followed by colonoscopy if the result is positive. The information quality of the Hemoccult test, however, is poor: in the asymptomatic 50 to 74 year-old population, the detection sensitivity of polyps more than 1 cm in diameter is of the order of 10 to 30% and is 35 to 50% for detecting colorectal cancers; specificity is 94 to 98% that of a complete colonoscopy. The I-FOBTs based on immunological detection and quantification of occult blood in stools are currently being evaluated; based on the threshold it can be more sensitive than FOBT, but enhances useless colonoscopies. Alternatively, with highest threshold of blood in stools, it may become highly specific and miss less advanced polyps. Faecal molecular tests based on the detection of human DNA anomalies (point gene mutations, methylation disorders of CG islets) appear to be more sensitive than the detection of occult blood in stools with no loss of specificity, but they are very expensive, thereby limiting their generalisation to the scale of population screening. A formal methylated DNA test has been validated in stools as well as in blood in a cohort of symptomatic individuals having undergone colonoscopy. The aim of the present study is to validate this test by taking advantage of the biotechnical expertise from renowned academic research teams and mass screening organisation.

DISEASE(S): Colorectal Cancer,Colorectal Neoplasms

PROVIDER: 2100326 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description: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

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Validation of an Alternative Biological Test to Increase the Detection Sensitivity of a Colon Tumour

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