Detection of colorectal serrated polyps by stool DNA testing: comparison with fecal immunochemical testing for occult blood (FIT)

Precursors to 1/3 of colorectal cancer (CRC), serrated polyps have been under-detected by screening due to their inconspicuous, non-hemorrhagic, and proximal nature. A new multi-target stool DNA test (multi-target sDNA) shows high sensitivity for both CRC and advanced adenomas. Screen detection of s...

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Veröffentlicht in:	PloS one 2014-01, Vol.9 (1), p.e85659-e85659
Hauptverfasser:	Heigh, Russell I, Yab, Tracy C, Taylor, William R, Hussain, Fareeda T N, Smyrk, Thomas C, Mahoney, Douglas W, Domanico, Michael J, Berger, Barry M, Lidgard, Graham P, Ahlquist, David A
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Sprache:	eng
Schlagworte:	Actin Adults Aged Analysis Analytical methods Blood Blood tests Colon Colonic Polyps - diagnosis Colonoscopy Colorectal cancer Colorectal carcinoma Defecation Deoxyribonucleic acid DNA DNA - analysis DNA testing Feces Feces - chemistry Female Gastroenterology Genetic markers Genetic testing Hemoglobin Hemoglobins Hemopoiesis Hemorrhage Hepatology Humans K-Ras protein Male Markers Mass Screening - methods Medical screening Medicine Middle Aged Muscle proteins Occult Blood Polyps Population Prospective Studies Sensitivity Sensitivity and Specificity Surveillance Tumors
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creator	Heigh, Russell I Yab, Tracy C Taylor, William R Hussain, Fareeda T N Smyrk, Thomas C Mahoney, Douglas W Domanico, Michael J Berger, Barry M Lidgard, Graham P Ahlquist, David A
description	Precursors to 1/3 of colorectal cancer (CRC), serrated polyps have been under-detected by screening due to their inconspicuous, non-hemorrhagic, and proximal nature. A new multi-target stool DNA test (multi-target sDNA) shows high sensitivity for both CRC and advanced adenomas. Screen detection of serrated polyps by this approach requires further validation. We sought to assess and compare noninvasive detection of sessile serrated polyps (SSP) ≥ 1 cm by sDNA and an occult blood fecal immunochemical test (FIT). In a blinded prospective study, a single stool sample used for both tests was collected from 456 asymptomatic adults prior to screening or surveillance colonoscopy (criterion standard). All 29 patients with SSP ≥ 1 cm were included as cases and all 232 with no neoplastic findings as controls. Buffered stool samples were processed and frozen on receipt; Exact Sciences performed sDNA in batches using optimized analytical methods. The sDNA multi-marker panel targets methylated BMP3 (mBMP3) and NDRG4, mutant KRAS, β-actin, and hemoglobin. FIT (Polymedco OC-FIT Check) was performed in separate lab ≤ 2 days post defecation and evaluated at cutoffs of 50 (FIT-50) and 100 ng/ml (FIT-100). MEDIAN AGES: cases 61 (range 57-77), controls 62 (52-70), p = NS. Women comprised 59% and 51%, p = NS, respectively. SSP median size was 1.2 cm (1-3 cm), 93% were proximal, and 64% had synchronous diminutive polyps. Among multi-target sDNA markers, mBMP3 proved highly discriminant for detection of SSP ≥ 1 cm (AUC = 0.87, p
doi_str_mv	10.1371/journal.pone.0085659
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A new multi-target stool DNA test (multi-target sDNA) shows high sensitivity for both CRC and advanced adenomas. Screen detection of serrated polyps by this approach requires further validation. We sought to assess and compare noninvasive detection of sessile serrated polyps (SSP) ≥ 1 cm by sDNA and an occult blood fecal immunochemical test (FIT). In a blinded prospective study, a single stool sample used for both tests was collected from 456 asymptomatic adults prior to screening or surveillance colonoscopy (criterion standard). All 29 patients with SSP ≥ 1 cm were included as cases and all 232 with no neoplastic findings as controls. Buffered stool samples were processed and frozen on receipt; Exact Sciences performed sDNA in batches using optimized analytical methods. The sDNA multi-marker panel targets methylated BMP3 (mBMP3) and NDRG4, mutant KRAS, β-actin, and hemoglobin. FIT (Polymedco OC-FIT Check) was performed in separate lab ≤ 2 days post defecation and evaluated at cutoffs of 50 (FIT-50) and 100 ng/ml (FIT-100). MEDIAN AGES: cases 61 (range 57-77), controls 62 (52-70), p = NS. Women comprised 59% and 51%, p = NS, respectively. SSP median size was 1.2 cm (1-3 cm), 93% were proximal, and 64% had synchronous diminutive polyps. Among multi-target sDNA markers, mBMP3 proved highly discriminant for detection of SSP ≥ 1 cm (AUC = 0.87, p<0.00001); other DNA markers provided no incremental sensitivity. Hemoglobin alone showed no discrimination (AUC = 0.50, p = NS). At matched specificities, detection of SSP ≥ 1 cm by stool mBMP3 was significantly greater than by FIT-50 (66% vs 10%, p = 0.0003) or FIT-100 (63% vs 0%, p<0.0001). In a screening and surveillance setting, SSP ≥ 1 cm can be detected noninvasively by stool assay of exfoliated DNA markers, especially mBMP3. FIT appears to have no value in SSP detection.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0085659</identifier><identifier>PMID: 24465639</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Actin ; Adults ; Aged ; Analysis ; Analytical methods ; Blood ; Blood tests ; Colon ; Colonic Polyps - diagnosis ; Colonoscopy ; Colorectal cancer ; Colorectal carcinoma ; Defecation ; Deoxyribonucleic acid ; DNA ; DNA - analysis ; DNA testing ; Feces ; Feces - chemistry ; Female ; Gastroenterology ; Genetic markers ; Genetic testing ; Hemoglobin ; Hemoglobins ; Hemopoiesis ; Hemorrhage ; Hepatology ; Humans ; K-Ras protein ; Male ; Markers ; Mass Screening - methods ; Medical screening ; Medicine ; Middle Aged ; Muscle proteins ; Occult Blood ; Polyps ; Population ; Prospective Studies ; Sensitivity ; Sensitivity and Specificity ; Surveillance ; Tumors</subject><ispartof>PloS one, 2014-01, Vol.9 (1), p.e85659-e85659</ispartof><rights>COPYRIGHT 2014 Public Library of Science</rights><rights>2014 Heigh et al. 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Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2014 Heigh et al 2014 Heigh et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c585t-b8cab3db36673d08d9cc3ebc9295b457842c8ee419147185bbb855fa402d2f0b3</citedby><cites>FETCH-LOGICAL-c585t-b8cab3db36673d08d9cc3ebc9295b457842c8ee419147185bbb855fa402d2f0b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3896420/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3896420/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2096,2915,23845,27901,27902,53766,53768,79569,79570</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24465639$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Heigh, Russell I</creatorcontrib><creatorcontrib>Yab, Tracy C</creatorcontrib><creatorcontrib>Taylor, William R</creatorcontrib><creatorcontrib>Hussain, Fareeda T N</creatorcontrib><creatorcontrib>Smyrk, Thomas C</creatorcontrib><creatorcontrib>Mahoney, Douglas W</creatorcontrib><creatorcontrib>Domanico, Michael J</creatorcontrib><creatorcontrib>Berger, Barry M</creatorcontrib><creatorcontrib>Lidgard, Graham P</creatorcontrib><creatorcontrib>Ahlquist, David A</creatorcontrib><title>Detection of colorectal serrated polyps by stool DNA testing: comparison with fecal immunochemical testing for occult blood (FIT)</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>Precursors to 1/3 of colorectal cancer (CRC), serrated polyps have been under-detected by screening due to their inconspicuous, non-hemorrhagic, and proximal nature. A new multi-target stool DNA test (multi-target sDNA) shows high sensitivity for both CRC and advanced adenomas. Screen detection of serrated polyps by this approach requires further validation. We sought to assess and compare noninvasive detection of sessile serrated polyps (SSP) ≥ 1 cm by sDNA and an occult blood fecal immunochemical test (FIT). In a blinded prospective study, a single stool sample used for both tests was collected from 456 asymptomatic adults prior to screening or surveillance colonoscopy (criterion standard). All 29 patients with SSP ≥ 1 cm were included as cases and all 232 with no neoplastic findings as controls. Buffered stool samples were processed and frozen on receipt; Exact Sciences performed sDNA in batches using optimized analytical methods. The sDNA multi-marker panel targets methylated BMP3 (mBMP3) and NDRG4, mutant KRAS, β-actin, and hemoglobin. 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FIT appears to have no value in SSP detection.</description><subject>Actin</subject><subject>Adults</subject><subject>Aged</subject><subject>Analysis</subject><subject>Analytical methods</subject><subject>Blood</subject><subject>Blood tests</subject><subject>Colon</subject><subject>Colonic Polyps - diagnosis</subject><subject>Colonoscopy</subject><subject>Colorectal cancer</subject><subject>Colorectal carcinoma</subject><subject>Defecation</subject><subject>Deoxyribonucleic acid</subject><subject>DNA</subject><subject>DNA - analysis</subject><subject>DNA testing</subject><subject>Feces</subject><subject>Feces - chemistry</subject><subject>Female</subject><subject>Gastroenterology</subject><subject>Genetic markers</subject><subject>Genetic testing</subject><subject>Hemoglobin</subject><subject>Hemoglobins</subject><subject>Hemopoiesis</subject><subject>Hemorrhage</subject><subject>Hepatology</subject><subject>Humans</subject><subject>K-Ras protein</subject><subject>Male</subject><subject>Markers</subject><subject>Mass Screening - 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Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Heigh, Russell I</au><au>Yab, Tracy C</au><au>Taylor, William R</au><au>Hussain, Fareeda T N</au><au>Smyrk, Thomas C</au><au>Mahoney, Douglas W</au><au>Domanico, Michael J</au><au>Berger, Barry M</au><au>Lidgard, Graham P</au><au>Ahlquist, David A</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Detection of colorectal serrated polyps by stool DNA testing: comparison with fecal immunochemical testing for occult blood (FIT)</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2014-01-20</date><risdate>2014</risdate><volume>9</volume><issue>1</issue><spage>e85659</spage><epage>e85659</epage><pages>e85659-e85659</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>Precursors to 1/3 of colorectal cancer (CRC), serrated polyps have been under-detected by screening due to their inconspicuous, non-hemorrhagic, and proximal nature. A new multi-target stool DNA test (multi-target sDNA) shows high sensitivity for both CRC and advanced adenomas. Screen detection of serrated polyps by this approach requires further validation. We sought to assess and compare noninvasive detection of sessile serrated polyps (SSP) ≥ 1 cm by sDNA and an occult blood fecal immunochemical test (FIT). In a blinded prospective study, a single stool sample used for both tests was collected from 456 asymptomatic adults prior to screening or surveillance colonoscopy (criterion standard). All 29 patients with SSP ≥ 1 cm were included as cases and all 232 with no neoplastic findings as controls. Buffered stool samples were processed and frozen on receipt; Exact Sciences performed sDNA in batches using optimized analytical methods. The sDNA multi-marker panel targets methylated BMP3 (mBMP3) and NDRG4, mutant KRAS, β-actin, and hemoglobin. FIT (Polymedco OC-FIT Check) was performed in separate lab ≤ 2 days post defecation and evaluated at cutoffs of 50 (FIT-50) and 100 ng/ml (FIT-100). MEDIAN AGES: cases 61 (range 57-77), controls 62 (52-70), p = NS. Women comprised 59% and 51%, p = NS, respectively. SSP median size was 1.2 cm (1-3 cm), 93% were proximal, and 64% had synchronous diminutive polyps. Among multi-target sDNA markers, mBMP3 proved highly discriminant for detection of SSP ≥ 1 cm (AUC = 0.87, p<0.00001); other DNA markers provided no incremental sensitivity. Hemoglobin alone showed no discrimination (AUC = 0.50, p = NS). At matched specificities, detection of SSP ≥ 1 cm by stool mBMP3 was significantly greater than by FIT-50 (66% vs 10%, p = 0.0003) or FIT-100 (63% vs 0%, p<0.0001). In a screening and surveillance setting, SSP ≥ 1 cm can be detected noninvasively by stool assay of exfoliated DNA markers, especially mBMP3. FIT appears to have no value in SSP detection.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>24465639</pmid><doi>10.1371/journal.pone.0085659</doi><oa>free_for_read</oa></addata></record>
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identifier	ISSN: 1932-6203
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subjects	Actin Adults Aged Analysis Analytical methods Blood Blood tests Colon Colonic Polyps - diagnosis Colonoscopy Colorectal cancer Colorectal carcinoma Defecation Deoxyribonucleic acid DNA DNA - analysis DNA testing Feces Feces - chemistry Female Gastroenterology Genetic markers Genetic testing Hemoglobin Hemoglobins Hemopoiesis Hemorrhage Hepatology Humans K-Ras protein Male Markers Mass Screening - methods Medical screening Medicine Middle Aged Muscle proteins Occult Blood Polyps Population Prospective Studies Sensitivity Sensitivity and Specificity Surveillance Tumors
title	Detection of colorectal serrated polyps by stool DNA testing: comparison with fecal immunochemical testing for occult blood (FIT)
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