Comparison of the performances of the ADXBLADDER test and urinary cytology in the follow‐up of non‐muscle‐invasive bladder cancer: a blinded prospective multicentric study
Objective To compare directly the performance of the ADXBLADDER test with that of cytology in the detection of non‐muscle‐invasive bladder cancer (NMIBC) recurrences. Background ADXBLADDER is a urine test based on the detection of MCM5, a DNA licensing factor expressed in all cells capable of dividi...
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| Veröffentlicht in: | BJU international 2021-02, Vol.127 (2), p.198-204 |
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| creator | Gontero, Paulo Montanari, Emanuele Roupret, Morgan Longo, Fabrizio Stockley, Jacqueline Kennedy, Ashleigh Rodriguez, Oscar McCracken, Stuart R.C. Dudderidge, Tim Sieverink, Caroline Vanié, Felicien Allasia, Marco Witjes, J. Alfred Sylvester, Richard Colombel, Marc Palou, Juan |
| description | Objective
To compare directly the performance of the ADXBLADDER test with that of cytology in the detection of non‐muscle‐invasive bladder cancer (NMIBC) recurrences.
Background
ADXBLADDER is a urine test based on the detection of MCM5, a DNA licensing factor expressed in all cells capable of dividing. Expression is usually restricted to the basal stem cell compartment; however, in malignancy, MCM5‐expressing cells can be found throughout the epithelium. Detection of MCM5 in urine sediment can be indicative of the presence of a bladder tumour.
Patients and Methods
A multicentre prospective, blinded study was carried out from August 2017 and July 2019 at 21 European Union centres, 14 of which collected matching cytology data. Urine was collected from patients prior to cystoscopy. Urine cytology and ADXBLADDER were performed and compared to the diagnosis obtained by cystoscopy. The performance of cytology and ADXBLADDER were then compared.
Results
The overall performance of ADXBLADDER demonstrated a sensitivity of 51.9%, a specificity of 66.4%, and a negative predictive value (NPV) of 92%. The sensitivity of ADXBLADDER for low‐ and high‐grade recurrences was 44.1% and 58.8%, respectively. By contrast, cytology sensitivity was 16.7%, specificity was 98% and NPV was 90.7%. Cytology sensitivity for both low‐ and high‐grade disease was 17.6%.
Conclusions
ADXBLADDER detection of both low‐ and high‐grade NMIBC recurrence is superior to that of cytology, with ADXBLADDER able to exclude the presence of high‐grade recurrence in 97.8% of cases compared to 97.1% with cytology. These results show that ADXBLADDER has promise as a more reliable alternative to urine cytology in the follow‐up of NMIBC. |
| doi_str_mv | 10.1111/bju.15194 |
| format | Article |
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To compare directly the performance of the ADXBLADDER test with that of cytology in the detection of non‐muscle‐invasive bladder cancer (NMIBC) recurrences.
Background
ADXBLADDER is a urine test based on the detection of MCM5, a DNA licensing factor expressed in all cells capable of dividing. Expression is usually restricted to the basal stem cell compartment; however, in malignancy, MCM5‐expressing cells can be found throughout the epithelium. Detection of MCM5 in urine sediment can be indicative of the presence of a bladder tumour.
Patients and Methods
A multicentre prospective, blinded study was carried out from August 2017 and July 2019 at 21 European Union centres, 14 of which collected matching cytology data. Urine was collected from patients prior to cystoscopy. Urine cytology and ADXBLADDER were performed and compared to the diagnosis obtained by cystoscopy. The performance of cytology and ADXBLADDER were then compared.
Results
The overall performance of ADXBLADDER demonstrated a sensitivity of 51.9%, a specificity of 66.4%, and a negative predictive value (NPV) of 92%. The sensitivity of ADXBLADDER for low‐ and high‐grade recurrences was 44.1% and 58.8%, respectively. By contrast, cytology sensitivity was 16.7%, specificity was 98% and NPV was 90.7%. Cytology sensitivity for both low‐ and high‐grade disease was 17.6%.
Conclusions
ADXBLADDER detection of both low‐ and high‐grade NMIBC recurrence is superior to that of cytology, with ADXBLADDER able to exclude the presence of high‐grade recurrence in 97.8% of cases compared to 97.1% with cytology. These results show that ADXBLADDER has promise as a more reliable alternative to urine cytology in the follow‐up of NMIBC.</description><identifier>ISSN: 1464-4096</identifier><identifier>EISSN: 1464-410X</identifier><identifier>DOI: 10.1111/bju.15194</identifier><identifier>PMID: 32745350</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>Aged ; biomarker ; Biomarkers, Tumor - urine ; Bladder cancer ; BladderCancer ; blcsm ; Cellular biology ; Cystoscopy - methods ; Cytology ; cytology MCM5 ; Epithelium ; Female ; Follow-Up Studies ; follow‐up ; Humans ; Invasiveness ; Life Sciences ; Male ; Malignancy ; non‐muscle‐invasive bladder cancer ; Original ; Prospective Studies ; Reproducibility of Results ; Stem cells ; surveillance ; Tumors ; Urinalysis - methods ; Urinary Bladder Neoplasms - diagnosis ; Urinary Bladder Neoplasms - urine ; Urine ; uroonc ; utuc</subject><ispartof>BJU international, 2021-02, Vol.127 (2), p.198-204</ispartof><rights>2020 The Authors BJU International published by John Wiley & Sons Ltd on behalf of BJU International</rights><rights>2020 The Authors BJU International published by John Wiley & Sons Ltd on behalf of BJU International.</rights><rights>2020. This article is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4774-a519b4454ba7e0cef651235d00b1fac1de072b1f361f4e4b36692926b2a580603</citedby><cites>FETCH-LOGICAL-c4774-a519b4454ba7e0cef651235d00b1fac1de072b1f361f4e4b36692926b2a580603</cites><orcidid>0000-0001-6668-4423 ; 0000-0001-6601-5107</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fbju.15194$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fbju.15194$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,780,784,885,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32745350$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.sorbonne-universite.fr/hal-03213155$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Gontero, Paulo</creatorcontrib><creatorcontrib>Montanari, Emanuele</creatorcontrib><creatorcontrib>Roupret, Morgan</creatorcontrib><creatorcontrib>Longo, Fabrizio</creatorcontrib><creatorcontrib>Stockley, Jacqueline</creatorcontrib><creatorcontrib>Kennedy, Ashleigh</creatorcontrib><creatorcontrib>Rodriguez, Oscar</creatorcontrib><creatorcontrib>McCracken, Stuart R.C.</creatorcontrib><creatorcontrib>Dudderidge, Tim</creatorcontrib><creatorcontrib>Sieverink, Caroline</creatorcontrib><creatorcontrib>Vanié, Felicien</creatorcontrib><creatorcontrib>Allasia, Marco</creatorcontrib><creatorcontrib>Witjes, J. Alfred</creatorcontrib><creatorcontrib>Sylvester, Richard</creatorcontrib><creatorcontrib>Colombel, Marc</creatorcontrib><creatorcontrib>Palou, Juan</creatorcontrib><title>Comparison of the performances of the ADXBLADDER test and urinary cytology in the follow‐up of non‐muscle‐invasive bladder cancer: a blinded prospective multicentric study</title><title>BJU international</title><addtitle>BJU Int</addtitle><description>Objective
To compare directly the performance of the ADXBLADDER test with that of cytology in the detection of non‐muscle‐invasive bladder cancer (NMIBC) recurrences.
Background
ADXBLADDER is a urine test based on the detection of MCM5, a DNA licensing factor expressed in all cells capable of dividing. Expression is usually restricted to the basal stem cell compartment; however, in malignancy, MCM5‐expressing cells can be found throughout the epithelium. Detection of MCM5 in urine sediment can be indicative of the presence of a bladder tumour.
Patients and Methods
A multicentre prospective, blinded study was carried out from August 2017 and July 2019 at 21 European Union centres, 14 of which collected matching cytology data. Urine was collected from patients prior to cystoscopy. Urine cytology and ADXBLADDER were performed and compared to the diagnosis obtained by cystoscopy. The performance of cytology and ADXBLADDER were then compared.
Results
The overall performance of ADXBLADDER demonstrated a sensitivity of 51.9%, a specificity of 66.4%, and a negative predictive value (NPV) of 92%. The sensitivity of ADXBLADDER for low‐ and high‐grade recurrences was 44.1% and 58.8%, respectively. By contrast, cytology sensitivity was 16.7%, specificity was 98% and NPV was 90.7%. Cytology sensitivity for both low‐ and high‐grade disease was 17.6%.
Conclusions
ADXBLADDER detection of both low‐ and high‐grade NMIBC recurrence is superior to that of cytology, with ADXBLADDER able to exclude the presence of high‐grade recurrence in 97.8% of cases compared to 97.1% with cytology. These results show that ADXBLADDER has promise as a more reliable alternative to urine cytology in the follow‐up of NMIBC.</description><subject>Aged</subject><subject>biomarker</subject><subject>Biomarkers, Tumor - urine</subject><subject>Bladder cancer</subject><subject>BladderCancer</subject><subject>blcsm</subject><subject>Cellular biology</subject><subject>Cystoscopy - methods</subject><subject>Cytology</subject><subject>cytology MCM5</subject><subject>Epithelium</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>follow‐up</subject><subject>Humans</subject><subject>Invasiveness</subject><subject>Life Sciences</subject><subject>Male</subject><subject>Malignancy</subject><subject>non‐muscle‐invasive bladder cancer</subject><subject>Original</subject><subject>Prospective Studies</subject><subject>Reproducibility of Results</subject><subject>Stem cells</subject><subject>surveillance</subject><subject>Tumors</subject><subject>Urinalysis - methods</subject><subject>Urinary Bladder Neoplasms - diagnosis</subject><subject>Urinary Bladder Neoplasms - urine</subject><subject>Urine</subject><subject>uroonc</subject><subject>utuc</subject><issn>1464-4096</issn><issn>1464-410X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>EIF</sourceid><recordid>eNp1kstu1DAUhiMEoqWw4AWQJTawmNaOL5mwQJrOFAoaCQlRqTvLcZyOR46d2vFU2fUR-iq8Ek-CM9MpUAlvfPT7838uOln2GsFjlM5JtY7HiKKSPMkOEWFkQhC8fLqPYckOshchrCFMAqPPswOcF4RiCg-zn3PXdsLr4CxwDehXCnTKN863wkoV9tpscXm6nC0WZ99Br0IPhK1B9NoKPwA59M64qwFou2UbZ4y7-XV7F7vxu3U2xW0M0qgUaLsRQW8UqIyoa-WBHBP5D0AkRdta1aDzLnRK9iPVRtNrqWzvtQShj_XwMnvWCBPUq_v7KLv4dPZjfj5Zfvv8ZT5bTiQpCjIRaR4VIZRUolBQqoZRlGNaQ1ihRkhUK1jkKcQMNUSRCjNW5mXOqlzQKWQQH2Ufd75drFpVb2sQhndet6lr7oTm_75YveJXbsOLaYkwniaD9zuD1aNv57MlHzWIc4QRpRuU2Hf3yby7jmnCvNVBKmOEVS4GnhMMcYGLokjo20fo2kVv0ygSNWUsn0JS_kku0zCDV81DBQjycWl4Whq-XZrEvvm70wdyvyUJONkBN9qo4f9O_PTrxc7yN5Yw0Pk</recordid><startdate>202102</startdate><enddate>202102</enddate><creator>Gontero, Paulo</creator><creator>Montanari, Emanuele</creator><creator>Roupret, Morgan</creator><creator>Longo, Fabrizio</creator><creator>Stockley, Jacqueline</creator><creator>Kennedy, Ashleigh</creator><creator>Rodriguez, Oscar</creator><creator>McCracken, Stuart R.C.</creator><creator>Dudderidge, Tim</creator><creator>Sieverink, Caroline</creator><creator>Vanié, Felicien</creator><creator>Allasia, Marco</creator><creator>Witjes, J. Alfred</creator><creator>Sylvester, Richard</creator><creator>Colombel, Marc</creator><creator>Palou, Juan</creator><general>Wiley Subscription Services, Inc</general><general>Wiley</general><general>John Wiley and Sons Inc</general><scope>24P</scope><scope>WIN</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QP</scope><scope>7X8</scope><scope>1XC</scope><scope>VOOES</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-6668-4423</orcidid><orcidid>https://orcid.org/0000-0001-6601-5107</orcidid></search><sort><creationdate>202102</creationdate><title>Comparison of the performances of the ADXBLADDER test and urinary cytology in the follow‐up of non‐muscle‐invasive bladder cancer: a blinded prospective multicentric study</title><author>Gontero, Paulo ; Montanari, Emanuele ; Roupret, Morgan ; Longo, Fabrizio ; Stockley, Jacqueline ; Kennedy, Ashleigh ; Rodriguez, Oscar ; McCracken, Stuart R.C. ; Dudderidge, Tim ; Sieverink, Caroline ; Vanié, Felicien ; Allasia, Marco ; Witjes, J. Alfred ; Sylvester, Richard ; Colombel, Marc ; Palou, Juan</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4774-a519b4454ba7e0cef651235d00b1fac1de072b1f361f4e4b36692926b2a580603</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Aged</topic><topic>biomarker</topic><topic>Biomarkers, Tumor - urine</topic><topic>Bladder cancer</topic><topic>BladderCancer</topic><topic>blcsm</topic><topic>Cellular biology</topic><topic>Cystoscopy - methods</topic><topic>Cytology</topic><topic>cytology MCM5</topic><topic>Epithelium</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>follow‐up</topic><topic>Humans</topic><topic>Invasiveness</topic><topic>Life Sciences</topic><topic>Male</topic><topic>Malignancy</topic><topic>non‐muscle‐invasive bladder cancer</topic><topic>Original</topic><topic>Prospective Studies</topic><topic>Reproducibility of Results</topic><topic>Stem cells</topic><topic>surveillance</topic><topic>Tumors</topic><topic>Urinalysis - methods</topic><topic>Urinary Bladder Neoplasms - diagnosis</topic><topic>Urinary Bladder Neoplasms - urine</topic><topic>Urine</topic><topic>uroonc</topic><topic>utuc</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Gontero, Paulo</creatorcontrib><creatorcontrib>Montanari, Emanuele</creatorcontrib><creatorcontrib>Roupret, Morgan</creatorcontrib><creatorcontrib>Longo, Fabrizio</creatorcontrib><creatorcontrib>Stockley, Jacqueline</creatorcontrib><creatorcontrib>Kennedy, Ashleigh</creatorcontrib><creatorcontrib>Rodriguez, Oscar</creatorcontrib><creatorcontrib>McCracken, Stuart R.C.</creatorcontrib><creatorcontrib>Dudderidge, Tim</creatorcontrib><creatorcontrib>Sieverink, Caroline</creatorcontrib><creatorcontrib>Vanié, Felicien</creatorcontrib><creatorcontrib>Allasia, Marco</creatorcontrib><creatorcontrib>Witjes, J. Alfred</creatorcontrib><creatorcontrib>Sylvester, Richard</creatorcontrib><creatorcontrib>Colombel, Marc</creatorcontrib><creatorcontrib>Palou, Juan</creatorcontrib><collection>Wiley Online Library Open Access</collection><collection>Wiley Online Library (Open Access Collection)</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><collection>Hyper Article en Ligne (HAL) (Open Access)</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BJU international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Gontero, Paulo</au><au>Montanari, Emanuele</au><au>Roupret, Morgan</au><au>Longo, Fabrizio</au><au>Stockley, Jacqueline</au><au>Kennedy, Ashleigh</au><au>Rodriguez, Oscar</au><au>McCracken, Stuart R.C.</au><au>Dudderidge, Tim</au><au>Sieverink, Caroline</au><au>Vanié, Felicien</au><au>Allasia, Marco</au><au>Witjes, J. Alfred</au><au>Sylvester, Richard</au><au>Colombel, Marc</au><au>Palou, Juan</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Comparison of the performances of the ADXBLADDER test and urinary cytology in the follow‐up of non‐muscle‐invasive bladder cancer: a blinded prospective multicentric study</atitle><jtitle>BJU international</jtitle><addtitle>BJU Int</addtitle><date>2021-02</date><risdate>2021</risdate><volume>127</volume><issue>2</issue><spage>198</spage><epage>204</epage><pages>198-204</pages><issn>1464-4096</issn><eissn>1464-410X</eissn><abstract>Objective
To compare directly the performance of the ADXBLADDER test with that of cytology in the detection of non‐muscle‐invasive bladder cancer (NMIBC) recurrences.
Background
ADXBLADDER is a urine test based on the detection of MCM5, a DNA licensing factor expressed in all cells capable of dividing. Expression is usually restricted to the basal stem cell compartment; however, in malignancy, MCM5‐expressing cells can be found throughout the epithelium. Detection of MCM5 in urine sediment can be indicative of the presence of a bladder tumour.
Patients and Methods
A multicentre prospective, blinded study was carried out from August 2017 and July 2019 at 21 European Union centres, 14 of which collected matching cytology data. Urine was collected from patients prior to cystoscopy. Urine cytology and ADXBLADDER were performed and compared to the diagnosis obtained by cystoscopy. The performance of cytology and ADXBLADDER were then compared.
Results
The overall performance of ADXBLADDER demonstrated a sensitivity of 51.9%, a specificity of 66.4%, and a negative predictive value (NPV) of 92%. The sensitivity of ADXBLADDER for low‐ and high‐grade recurrences was 44.1% and 58.8%, respectively. By contrast, cytology sensitivity was 16.7%, specificity was 98% and NPV was 90.7%. Cytology sensitivity for both low‐ and high‐grade disease was 17.6%.
Conclusions
ADXBLADDER detection of both low‐ and high‐grade NMIBC recurrence is superior to that of cytology, with ADXBLADDER able to exclude the presence of high‐grade recurrence in 97.8% of cases compared to 97.1% with cytology. These results show that ADXBLADDER has promise as a more reliable alternative to urine cytology in the follow‐up of NMIBC.</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>32745350</pmid><doi>10.1111/bju.15194</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0001-6668-4423</orcidid><orcidid>https://orcid.org/0000-0001-6601-5107</orcidid><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; Access via Wiley Online Library |
| subjects | Aged biomarker Biomarkers, Tumor - urine Bladder cancer BladderCancer blcsm Cellular biology Cystoscopy - methods Cytology cytology MCM5 Epithelium Female Follow-Up Studies follow‐up Humans Invasiveness Life Sciences Male Malignancy non‐muscle‐invasive bladder cancer Original Prospective Studies Reproducibility of Results Stem cells surveillance Tumors Urinalysis - methods Urinary Bladder Neoplasms - diagnosis Urinary Bladder Neoplasms - urine Urine uroonc utuc |
| title | Comparison of the performances of the ADXBLADDER test and urinary cytology in the follow‐up of non‐muscle‐invasive bladder cancer: a blinded prospective multicentric study |
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