Exploring the utility and acceptability of Faecal immunochemical testing : a single-arm, prospective, multi-centre, non-randomised study
Lynch Syndrome (LS) is an inherited cancer predisposition syndrome defined by pathogenic variants in the mismatch repair (MMR) or EPCAM genes. In the United Kingdom, people with LS are advised to undergo biennial colonoscopy from as early as 25 until 75 years of age to mitigate a high lifetime color...
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description | Lynch Syndrome (LS) is an inherited cancer predisposition syndrome defined by pathogenic variants in the mismatch repair (MMR) or EPCAM genes. In the United Kingdom, people with LS are advised to undergo biennial colonoscopy from as early as 25 until 75 years of age to mitigate a high lifetime colorectal cancer (CRC) risk, though the consideration of additional surveillance intervention(s) through the application of non-invasive diagnostic devices has yet to be longitudinally observed in LS patients. In this study, we will examine the role of annual faecal immunochemical testing (FIT) alongside biennial colonoscopy for CRC surveillance in people with LS. In this single-arm, prospective, non-randomised study, 400 LS patients will be recruited across 11 National Health Service (NHS) Trusts throughout the United Kingdom. Study inclusion requires a LS diagnosis, between 25 and 73 years old, and a routine surveillance colonoscopy scheduled during the recruitment period. Eligible patients will receive a baseline OC-Sensor[TM] FIT kit ahead of their colonoscopy, and annually for 3 years thereafter. A pre-paid envelope addressed to the central lab will be included within all patient mailings for the return of FIT kits and relevant study documents. A questionnaire assessing attitudes and perception of FIT will also be included at baseline. All study samples received by the central lab will be assayed on an OC-Sensor[TM] PLEDIA Analyser. Patients with FIT results of [greater than or equal to]6 [mu]g of Haemoglobin per gram of faeces (f-Hb) at Years 1 and/or 3 will be referred for colonoscopy via an urgent colonoscopy triage pathway. FIT may have clinical utility alongside colonoscopic surveillance in people with LS. We have designed a longitudinal study to examine the efficacy of FIT as a non-invasive modality. Potential limitations of this method will be assessed, including false negative or false positive FIT results related to specific morphological features of LS neoplasia or the presence of post-resection anastomotic inflammation. The potential for additional colonoscopies in a subset of participants may also impact on colonoscopic resources and patient acceptability. |
doi_str_mv | 10.1186/s12885-022-10217-y |
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In the United Kingdom, people with LS are advised to undergo biennial colonoscopy from as early as 25 until 75 years of age to mitigate a high lifetime colorectal cancer (CRC) risk, though the consideration of additional surveillance intervention(s) through the application of non-invasive diagnostic devices has yet to be longitudinally observed in LS patients. In this study, we will examine the role of annual faecal immunochemical testing (FIT) alongside biennial colonoscopy for CRC surveillance in people with LS. In this single-arm, prospective, non-randomised study, 400 LS patients will be recruited across 11 National Health Service (NHS) Trusts throughout the United Kingdom. Study inclusion requires a LS diagnosis, between 25 and 73 years old, and a routine surveillance colonoscopy scheduled during the recruitment period. Eligible patients will receive a baseline OC-Sensor[TM] FIT kit ahead of their colonoscopy, and annually for 3 years thereafter. A pre-paid envelope addressed to the central lab will be included within all patient mailings for the return of FIT kits and relevant study documents. A questionnaire assessing attitudes and perception of FIT will also be included at baseline. All study samples received by the central lab will be assayed on an OC-Sensor[TM] PLEDIA Analyser. Patients with FIT results of [greater than or equal to]6 [mu]g of Haemoglobin per gram of faeces (f-Hb) at Years 1 and/or 3 will be referred for colonoscopy via an urgent colonoscopy triage pathway. FIT may have clinical utility alongside colonoscopic surveillance in people with LS. We have designed a longitudinal study to examine the efficacy of FIT as a non-invasive modality. Potential limitations of this method will be assessed, including false negative or false positive FIT results related to specific morphological features of LS neoplasia or the presence of post-resection anastomotic inflammation. The potential for additional colonoscopies in a subset of participants may also impact on colonoscopic resources and patient acceptability.</description><identifier>ISSN: 1471-2407</identifier><identifier>EISSN: 1471-2407</identifier><identifier>DOI: 10.1186/s12885-022-10217-y</identifier><language>eng</language><publisher>BioMed Central Ltd</publisher><subject>Care and treatment ; Colonoscopy ; Colorectal cancer ; Development and progression ; Genetic aspects ; Methods</subject><ispartof>BMC cancer, 2022-11, Vol.22 (1)</ispartof><rights>COPYRIGHT 2022 BioMed Central Ltd.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,864,27924,27925</link.rule.ids></links><search><creatorcontrib>Lincoln, Anne</creatorcontrib><creatorcontrib>Benton, Sally</creatorcontrib><creatorcontrib>Piggott, Carolyn</creatorcontrib><creatorcontrib>North, Bernard V</creatorcontrib><creatorcontrib>Rigney, Jane</creatorcontrib><creatorcontrib>Young, Caroline</creatorcontrib><creatorcontrib>Quirke, Philip</creatorcontrib><creatorcontrib>Sasieni, Peter</creatorcontrib><creatorcontrib>Monahan, Kevin J</creatorcontrib><title>Exploring the utility and acceptability of Faecal immunochemical testing : a single-arm, prospective, multi-centre, non-randomised study</title><title>BMC cancer</title><description>Lynch Syndrome (LS) is an inherited cancer predisposition syndrome defined by pathogenic variants in the mismatch repair (MMR) or EPCAM genes. In the United Kingdom, people with LS are advised to undergo biennial colonoscopy from as early as 25 until 75 years of age to mitigate a high lifetime colorectal cancer (CRC) risk, though the consideration of additional surveillance intervention(s) through the application of non-invasive diagnostic devices has yet to be longitudinally observed in LS patients. In this study, we will examine the role of annual faecal immunochemical testing (FIT) alongside biennial colonoscopy for CRC surveillance in people with LS. In this single-arm, prospective, non-randomised study, 400 LS patients will be recruited across 11 National Health Service (NHS) Trusts throughout the United Kingdom. Study inclusion requires a LS diagnosis, between 25 and 73 years old, and a routine surveillance colonoscopy scheduled during the recruitment period. Eligible patients will receive a baseline OC-Sensor[TM] FIT kit ahead of their colonoscopy, and annually for 3 years thereafter. A pre-paid envelope addressed to the central lab will be included within all patient mailings for the return of FIT kits and relevant study documents. A questionnaire assessing attitudes and perception of FIT will also be included at baseline. All study samples received by the central lab will be assayed on an OC-Sensor[TM] PLEDIA Analyser. Patients with FIT results of [greater than or equal to]6 [mu]g of Haemoglobin per gram of faeces (f-Hb) at Years 1 and/or 3 will be referred for colonoscopy via an urgent colonoscopy triage pathway. FIT may have clinical utility alongside colonoscopic surveillance in people with LS. We have designed a longitudinal study to examine the efficacy of FIT as a non-invasive modality. Potential limitations of this method will be assessed, including false negative or false positive FIT results related to specific morphological features of LS neoplasia or the presence of post-resection anastomotic inflammation. The potential for additional colonoscopies in a subset of participants may also impact on colonoscopic resources and patient acceptability.</description><subject>Care and treatment</subject><subject>Colonoscopy</subject><subject>Colorectal cancer</subject><subject>Development and progression</subject><subject>Genetic aspects</subject><subject>Methods</subject><issn>1471-2407</issn><issn>1471-2407</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><recordid>eNptT8tKAzEUDaJgrf6Aq4AroalJJjNJ3ZXSaqEg-FiXNLkzjcyLSUbaP_CzTamLCnIX95zDOfeB0C2jY8ZU9uAZVyollHPCKGeS7M_QgAnJCBdUnp_gS3Tl_SelTCqqBuh7vmvLpnN1gcMWcB9c6cIe69pibQy0QW-OSpPjhQajS-yqqq8bs4XKHWgAHw7xR6yxj6AEortqhNuu8S2Y4L5ghKu-DI4YqEMXWd3UpIsrmsp5sNiH3u6v0UWuSw83v32IPhbz99kzWb08LWfTFSkYZRMiIJUMlNA0T6QUPNmIBDKAlOZcM24za2UqjZV0wxKbaqMzDTRRygopDM2SIbo7zi10CWtX503otImHmPVU8jRL2YROomv8jyuWPXzd1JC7qP8J3P8JRE-AXSh07_16-fZ66v0BXB-D4w</recordid><startdate>20221107</startdate><enddate>20221107</enddate><creator>Lincoln, Anne</creator><creator>Benton, Sally</creator><creator>Piggott, Carolyn</creator><creator>North, Bernard V</creator><creator>Rigney, Jane</creator><creator>Young, Caroline</creator><creator>Quirke, Philip</creator><creator>Sasieni, Peter</creator><creator>Monahan, Kevin J</creator><general>BioMed Central Ltd</general><scope>ISR</scope></search><sort><creationdate>20221107</creationdate><title>Exploring the utility and acceptability of Faecal immunochemical testing : a single-arm, prospective, multi-centre, non-randomised study</title><author>Lincoln, Anne ; Benton, Sally ; Piggott, Carolyn ; North, Bernard V ; Rigney, Jane ; Young, Caroline ; Quirke, Philip ; Sasieni, Peter ; Monahan, Kevin J</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-g1019-4e571e84a0f377423b43e6ee50f2a12d6dd757cd70b13d5aca6ae0388d474c063</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Care and treatment</topic><topic>Colonoscopy</topic><topic>Colorectal cancer</topic><topic>Development and progression</topic><topic>Genetic aspects</topic><topic>Methods</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lincoln, Anne</creatorcontrib><creatorcontrib>Benton, Sally</creatorcontrib><creatorcontrib>Piggott, Carolyn</creatorcontrib><creatorcontrib>North, Bernard V</creatorcontrib><creatorcontrib>Rigney, Jane</creatorcontrib><creatorcontrib>Young, Caroline</creatorcontrib><creatorcontrib>Quirke, Philip</creatorcontrib><creatorcontrib>Sasieni, Peter</creatorcontrib><creatorcontrib>Monahan, Kevin J</creatorcontrib><collection>Gale In Context: Science</collection><jtitle>BMC cancer</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lincoln, Anne</au><au>Benton, Sally</au><au>Piggott, Carolyn</au><au>North, Bernard V</au><au>Rigney, Jane</au><au>Young, Caroline</au><au>Quirke, Philip</au><au>Sasieni, Peter</au><au>Monahan, Kevin J</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Exploring the utility and acceptability of Faecal immunochemical testing : a single-arm, prospective, multi-centre, non-randomised study</atitle><jtitle>BMC cancer</jtitle><date>2022-11-07</date><risdate>2022</risdate><volume>22</volume><issue>1</issue><issn>1471-2407</issn><eissn>1471-2407</eissn><abstract>Lynch Syndrome (LS) is an inherited cancer predisposition syndrome defined by pathogenic variants in the mismatch repair (MMR) or EPCAM genes. In the United Kingdom, people with LS are advised to undergo biennial colonoscopy from as early as 25 until 75 years of age to mitigate a high lifetime colorectal cancer (CRC) risk, though the consideration of additional surveillance intervention(s) through the application of non-invasive diagnostic devices has yet to be longitudinally observed in LS patients. In this study, we will examine the role of annual faecal immunochemical testing (FIT) alongside biennial colonoscopy for CRC surveillance in people with LS. In this single-arm, prospective, non-randomised study, 400 LS patients will be recruited across 11 National Health Service (NHS) Trusts throughout the United Kingdom. Study inclusion requires a LS diagnosis, between 25 and 73 years old, and a routine surveillance colonoscopy scheduled during the recruitment period. Eligible patients will receive a baseline OC-Sensor[TM] FIT kit ahead of their colonoscopy, and annually for 3 years thereafter. A pre-paid envelope addressed to the central lab will be included within all patient mailings for the return of FIT kits and relevant study documents. A questionnaire assessing attitudes and perception of FIT will also be included at baseline. All study samples received by the central lab will be assayed on an OC-Sensor[TM] PLEDIA Analyser. Patients with FIT results of [greater than or equal to]6 [mu]g of Haemoglobin per gram of faeces (f-Hb) at Years 1 and/or 3 will be referred for colonoscopy via an urgent colonoscopy triage pathway. FIT may have clinical utility alongside colonoscopic surveillance in people with LS. We have designed a longitudinal study to examine the efficacy of FIT as a non-invasive modality. Potential limitations of this method will be assessed, including false negative or false positive FIT results related to specific morphological features of LS neoplasia or the presence of post-resection anastomotic inflammation. The potential for additional colonoscopies in a subset of participants may also impact on colonoscopic resources and patient acceptability.</abstract><pub>BioMed Central Ltd</pub><doi>10.1186/s12885-022-10217-y</doi></addata></record> |
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subjects | Care and treatment Colonoscopy Colorectal cancer Development and progression Genetic aspects Methods |
title | Exploring the utility and acceptability of Faecal immunochemical testing : a single-arm, prospective, multi-centre, non-randomised study |
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