An efficient strategy for evaluating new non-invasive screening tests for colorectal cancer: the guiding principles
Objective: New screening tests for colorectal cancer (CRC) are rapidly emerging. Conducting trials with mortality reduction as the end point supporting their adoption is challenging. We re-examined the principles underlying evaluation of new non-invasive tests in view of technological developments a...
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| Format: | Journal Article |
| Language: | English |
| Published: |
2024
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| Subjects: | |
| Online Access: | https://hdl.handle.net/10356/174162 |
| _version_ | 1826111285445525504 |
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| author | Bresalier, Robert S. Senore, Carlo Young, Graeme P. Allison, James Benamouzig, Robert Benton, Sally Bossuyt, Patrick M. M. Caro, Luis Carvalho, Beatriz Chiu, Han-Mo Coupé, Veerle M. H. de Klaver, Willemijn de Klerk, Clasine Maria Dekker, Evelien Dolwani, Sunil Fraser, Callum G. Grady, William Guittet, Lydia Gupta, Samir Halloran, Stephen P. Haug, Ulrike Hoff, Geir Itzkowitz, Steven Kortlever, Tim Koulaouzidis, Anastasios Ladabaum, Uri Lauby-Secretan, Beatrice Leja, Mārcis Levin, Bernard Levin, Theodore Robert Macrae, Finlay Meijer, Gerrit A. Melson, Joshua O'Morain, Colm Parry, Susan Rabeneck, Linda Ransohoff, David F. Sáenz, Roque Saito, Hiroshi Sanduleanu-Dascalescu, Silvia Schoen, Robert E. Selby, Kevin Singh, Harminder Steele, Robert J. C. Sung, Joseph Jao Yiu Symonds, Erin Leigh Winawer, Sidney J. |
| author2 | Lee Kong Chian School of Medicine (LKCMedicine) |
| author_facet | Lee Kong Chian School of Medicine (LKCMedicine) Bresalier, Robert S. Senore, Carlo Young, Graeme P. Allison, James Benamouzig, Robert Benton, Sally Bossuyt, Patrick M. M. Caro, Luis Carvalho, Beatriz Chiu, Han-Mo Coupé, Veerle M. H. de Klaver, Willemijn de Klerk, Clasine Maria Dekker, Evelien Dolwani, Sunil Fraser, Callum G. Grady, William Guittet, Lydia Gupta, Samir Halloran, Stephen P. Haug, Ulrike Hoff, Geir Itzkowitz, Steven Kortlever, Tim Koulaouzidis, Anastasios Ladabaum, Uri Lauby-Secretan, Beatrice Leja, Mārcis Levin, Bernard Levin, Theodore Robert Macrae, Finlay Meijer, Gerrit A. Melson, Joshua O'Morain, Colm Parry, Susan Rabeneck, Linda Ransohoff, David F. Sáenz, Roque Saito, Hiroshi Sanduleanu-Dascalescu, Silvia Schoen, Robert E. Selby, Kevin Singh, Harminder Steele, Robert J. C. Sung, Joseph Jao Yiu Symonds, Erin Leigh Winawer, Sidney J. |
| author_sort | Bresalier, Robert S. |
| collection | NTU |
| description | Objective: New screening tests for colorectal cancer (CRC) are rapidly emerging. Conducting trials with mortality reduction as the end point supporting their adoption is challenging. We re-examined the principles underlying evaluation of new non-invasive tests in view of technological developments and identification of new biomarkers. Design: A formal consensus approach involving a multidisciplinary expert panel revised eight previously established principles. Results: Twelve newly stated principles emerged. Effectiveness of a new test can be evaluated by comparison with a proven comparator non-invasive test. The faecal immunochemical test is now considered the appropriate comparator, while colonoscopy remains the diagnostic standard. For a new test to be able to meet differing screening goals and regulatory requirements, flexibility to adjust its positivity threshold is desirable. A rigorous and efficient four-phased approach is proposed, commencing with small studies assessing the test's ability to discriminate between CRC and non-cancer states (phase I), followed by prospective estimation of accuracy across the continuum of neoplastic lesions in neoplasia-enriched populations (phase II). If these show promise, a provisional test positivity threshold is set before evaluation in typical screening populations. Phase III prospective studies determine single round intention-to-screen programme outcomes and confirm the test positivity threshold. Phase IV studies involve evaluation over repeated screening rounds with monitoring for missed lesions. Phases III and IV findings will provide the real-world data required to model test impact on CRC mortality and incidence. Conclusion: New non-invasive tests can be efficiently evaluated by a rigorous phased comparative approach, generating data from unbiased populations that inform predictions of their health impact. |
| first_indexed | 2024-10-01T02:48:30Z |
| format | Journal Article |
| id | ntu-10356/174162 |
| institution | Nanyang Technological University |
| language | English |
| last_indexed | 2024-10-01T02:48:30Z |
| publishDate | 2024 |
| record_format | dspace |
| spelling | ntu-10356/1741622024-03-24T15:38:32Z An efficient strategy for evaluating new non-invasive screening tests for colorectal cancer: the guiding principles Bresalier, Robert S. Senore, Carlo Young, Graeme P. Allison, James Benamouzig, Robert Benton, Sally Bossuyt, Patrick M. M. Caro, Luis Carvalho, Beatriz Chiu, Han-Mo Coupé, Veerle M. H. de Klaver, Willemijn de Klerk, Clasine Maria Dekker, Evelien Dolwani, Sunil Fraser, Callum G. Grady, William Guittet, Lydia Gupta, Samir Halloran, Stephen P. Haug, Ulrike Hoff, Geir Itzkowitz, Steven Kortlever, Tim Koulaouzidis, Anastasios Ladabaum, Uri Lauby-Secretan, Beatrice Leja, Mārcis Levin, Bernard Levin, Theodore Robert Macrae, Finlay Meijer, Gerrit A. Melson, Joshua O'Morain, Colm Parry, Susan Rabeneck, Linda Ransohoff, David F. Sáenz, Roque Saito, Hiroshi Sanduleanu-Dascalescu, Silvia Schoen, Robert E. Selby, Kevin Singh, Harminder Steele, Robert J. C. Sung, Joseph Jao Yiu Symonds, Erin Leigh Winawer, Sidney J. Lee Kong Chian School of Medicine (LKCMedicine) Medicine, Health and Life Sciences Colorectal adenomas Colorectal cancer Objective: New screening tests for colorectal cancer (CRC) are rapidly emerging. Conducting trials with mortality reduction as the end point supporting their adoption is challenging. We re-examined the principles underlying evaluation of new non-invasive tests in view of technological developments and identification of new biomarkers. Design: A formal consensus approach involving a multidisciplinary expert panel revised eight previously established principles. Results: Twelve newly stated principles emerged. Effectiveness of a new test can be evaluated by comparison with a proven comparator non-invasive test. The faecal immunochemical test is now considered the appropriate comparator, while colonoscopy remains the diagnostic standard. For a new test to be able to meet differing screening goals and regulatory requirements, flexibility to adjust its positivity threshold is desirable. A rigorous and efficient four-phased approach is proposed, commencing with small studies assessing the test's ability to discriminate between CRC and non-cancer states (phase I), followed by prospective estimation of accuracy across the continuum of neoplastic lesions in neoplasia-enriched populations (phase II). If these show promise, a provisional test positivity threshold is set before evaluation in typical screening populations. Phase III prospective studies determine single round intention-to-screen programme outcomes and confirm the test positivity threshold. Phase IV studies involve evaluation over repeated screening rounds with monitoring for missed lesions. Phases III and IV findings will provide the real-world data required to model test impact on CRC mortality and incidence. Conclusion: New non-invasive tests can be efficiently evaluated by a rigorous phased comparative approach, generating data from unbiased populations that inform predictions of their health impact. Published version 2024-03-18T04:49:45Z 2024-03-18T04:49:45Z 2023 Journal Article Bresalier, R. S., Senore, C., Young, G. P., Allison, J., Benamouzig, R., Benton, S., Bossuyt, P. M. M., Caro, L., Carvalho, B., Chiu, H., Coupé, V. M. H., de Klaver, W., de Klerk, C. M., Dekker, E., Dolwani, S., Fraser, C. G., Grady, W., Guittet, L., Gupta, S., ...Winawer, S. J. (2023). An efficient strategy for evaluating new non-invasive screening tests for colorectal cancer: the guiding principles. Gut, 72(10), 1904-1918. https://dx.doi.org/10.1136/gutjnl-2023-329701 0017-5749 https://hdl.handle.net/10356/174162 10.1136/gutjnl-2023-329701 37463757 2-s2.0-85166413371 10 72 1904 1918 en Gut © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. application/pdf |
| spellingShingle | Medicine, Health and Life Sciences Colorectal adenomas Colorectal cancer Bresalier, Robert S. Senore, Carlo Young, Graeme P. Allison, James Benamouzig, Robert Benton, Sally Bossuyt, Patrick M. M. Caro, Luis Carvalho, Beatriz Chiu, Han-Mo Coupé, Veerle M. H. de Klaver, Willemijn de Klerk, Clasine Maria Dekker, Evelien Dolwani, Sunil Fraser, Callum G. Grady, William Guittet, Lydia Gupta, Samir Halloran, Stephen P. Haug, Ulrike Hoff, Geir Itzkowitz, Steven Kortlever, Tim Koulaouzidis, Anastasios Ladabaum, Uri Lauby-Secretan, Beatrice Leja, Mārcis Levin, Bernard Levin, Theodore Robert Macrae, Finlay Meijer, Gerrit A. Melson, Joshua O'Morain, Colm Parry, Susan Rabeneck, Linda Ransohoff, David F. Sáenz, Roque Saito, Hiroshi Sanduleanu-Dascalescu, Silvia Schoen, Robert E. Selby, Kevin Singh, Harminder Steele, Robert J. C. Sung, Joseph Jao Yiu Symonds, Erin Leigh Winawer, Sidney J. An efficient strategy for evaluating new non-invasive screening tests for colorectal cancer: the guiding principles |
| title | An efficient strategy for evaluating new non-invasive screening tests for colorectal cancer: the guiding principles |
| title_full | An efficient strategy for evaluating new non-invasive screening tests for colorectal cancer: the guiding principles |
| title_fullStr | An efficient strategy for evaluating new non-invasive screening tests for colorectal cancer: the guiding principles |
| title_full_unstemmed | An efficient strategy for evaluating new non-invasive screening tests for colorectal cancer: the guiding principles |
| title_short | An efficient strategy for evaluating new non-invasive screening tests for colorectal cancer: the guiding principles |
| title_sort | efficient strategy for evaluating new non invasive screening tests for colorectal cancer the guiding principles |
| topic | Medicine, Health and Life Sciences Colorectal adenomas Colorectal cancer |
| url | https://hdl.handle.net/10356/174162 |
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