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. 2010;5(2):62-65.
doi: 10.1159/000303956. Epub 2010 Apr 21.

Biomarkers for Early Cancer Detection - Methodological Aspects

Paolo Verderio  1 , Anita Mangia, Chiara M Ciniselli, Paola Tagliabue, Angelo Paradiso
Affiliations

Biomarkers for Early Cancer Detection - Methodological Aspects

Paolo Verderio et al. Breast Care (Basel). 2010.

Abstract
in English, German

The development of a new breast cancer biomarker for early detection is a process that begins with biomarker discovery, followed by a rigorous definition and evaluation of the whole process of biomarker determination (analytical validation). It terminates with the assessment of the impact of the biomarker on clinical practice (clinical validation). A 4-phase scheme for the analytical validation process of the biomarkers for early diagnosis has recently been proposed with the aim of covering the need for standardized operating procedures as well as the need for monitoring and maintaining their quality. As far as clinical validation of biomarkers for early diagnosis is concerned, however, a well established phased approach exists, and guidelines are available for both planning studies and reporting results. Although analytical and clinical validation should be logically linked, often this is not the case in real-word practice, especially in the early phases of biomarker development. This is also the case with breast cancer biomarkers for early detection.

Der Prozess der Entwicklung neuer Biomarker für die Brustkrebsfrüherkennung beginnt mit der Entdeckung des Biomarkers, gefolgt von einer strengen Definition und Bewertung des Gesamtprozesses der Biomarker-Ermittlung (analytische Validierung). Der Vorgang endet mit der Einschätzung der Auswirkung des Biomarkers auf die klinische Praxis (klinische Validierung). Vor kurzem ist ein 4-Phasen-Schema für die analytische Validierung von Biomarkern für die Früherkennung vorgeschlagen worden, mit dem Ziel, den Bedarf an standardisierten Operating Procedures zu decken und deren Überwachung und langfristige Qualität zu gewährleisten. Für die klinische Validierung von Biomarkern für die Frühdiagnose existiert dagegen bereits ein etabliertes schrittweises Verfahren, und es sind Richtlinien für sowohl die Studienplanung als auch das Berichten von Ergebnissen vorhanden. Die analytische und die klinische Validierung sollten in logischer Folge miteinander gekoppelt sein, aber in der Praxis ist dies oft nicht der Fall, insbesondere in den frühen Phasen der Biomarkerentwicklung. Dies trifft auch auch die Biomarker für die Brustkrebsfrüherkennung zu.

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