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1、BackgroundBackground CRC: major cause of death and disease BackgroundBackground Processes of colorectal carcinogenesis lend themselves to screening BackgroundBackground A substantial proportion never tested! Screening for CRC is cost- effective A simple, noninvasive test might improve clinical out-

2、comes 28% BackgroundBackground Colorectal cancer arises from accumulated genetic and epigenetic alterations AimAim Evaluate the multitarget stool DNA test as a tool for screening AimAim Primary aim: DNA test in the detection of CRC Secondary aims: DNA test in the detection of advanced precancerous l

3、esions and to compare it with a commercially available fecal immunochemical test (FIT) DNA test VS MethodsMethods Study Population: l 2011.6-2012.11 90 sites Asymptomatic persons Ages of 50 to 84 at average risk for CRC Scheduled to undergo screeningcolonoscopy MethodsMethods Excluded l personal his

4、tory : colorectal neoplasia, digestive cancer, or inflammatory bowel disease l previous colonoscopy , barium enema, CT ,sigmoidoscopy l positive results on fecal blood testing, rectal bleeding l undergone colorectal resection l family history MethodsMethods Primary and Secondary Outcomes lCRC, stage

5、 determined with the use of the AJCC staging system l Advanced precancerous lesions: Advanced adenomas high-grade dysplasia with 25% villous histologic features measure 1cm in the greatest dimension Sessile serrated polyps measuring 1 cm or more in diameter aberrantly methylated BMP3 and NDRG4promot

6、er regions mutant KRAS immunoche mical assay for human hemoglobin FIT Multitarget stool DNA test ResultsResults 12776 0.7% 7.6% ResultsResults ResultsResults ResultsResults Figure 3.Receiver Operating Characteristic (ROC) Curves Comparing DNA Testing and FIT for the Detection of Colorectal Cancer an

7、d Advanced Colorectal Neoplasia. ResultsResults Multitarget DNA testing detected clinically significant lesions more efficiently than FIT. ConclusionsConclusions A stool test combining altered human DNA and fecal hemoglobin showed higher sensitivity than a commercial FIT for both CRC and advanced pr

8、ecancerous lesions, although with lower specificity. Translational ResearchTranslational Research Aug. 12, 2014 FDA Approves Cologuard First and Only Stool DNA Noninvasive Colorectal Cancer Screening Test Received a proposed cove- rage memorandum from the Centers for Medicare and Medicaid Services (

9、CMS) People at average risk for colorectal cancer An easy-to-use screen- ing test 599$ BackgroundBackground A substantial proportion never tested! Screening for CRC is cost- effective A simple, noninvasive test might improve clinical out- comes 28% MethodsMethods Study Population: l 2011.6-2012.11 9

10、0 sites Asymptomatic persons Ages of 50 to 84 at average risk for CRC Scheduled to undergo screeningcolonoscopy MethodsMethods Primary and Secondary Outcomes lCRC, stage determined with the use of the AJCC staging system l Advanced precancerous lesions: Advanced adenomas high-grade dysplasia with 25

11、% villous histologic features measure 1cm in the greatest dimension Sessile serrated polyps measuring 1 cm or more in diameter ResultsResults Figure 3.Receiver Operating Characteristic (ROC) Curves Comparing DNA Testing and FIT for the Detection of Colorectal Cancer and Advanced Colorectal Neoplasia. ConclusionsConclusions A stool test com