Details

Autor(en) / Beteiligte

• 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 J Y
• Symonds, Erin Leigh
• Winawer, Sidney J

Titel

An efficient strategy for evaluating new non-invasive screening tests for colorectal cancer: the guiding principles

Ist Teil von

• Gut, 2023-10, Vol.72 (10), p.1904

Ort / Verlag

England

Erscheinungsjahr

2023

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• 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. A formal consensus approach involving a multidisciplinary expert panel revised eight previously established principles. 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 ( ), followed by prospective estimation of accuracy across the continuum of neoplastic lesions in neoplasia-enriched populations ( ). If these show promise, a provisional test positivity threshold is set before evaluation in typical screening populations. prospective studies determine single round intention-to-screen programme outcomes and confirm the test positivity threshold. 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. 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.