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  • Soletormos, Gyorgy (author)

Design of Tumor Biomarker-Monitoring Trials : A Proposal by the European Group on Tumor Markers

  • Article/chapterEnglish2013

Publisher, publication year, extent ...

  • 2013-01-01
  • Oxford University Press (OUP),2013
  • printrdacarrier

Numbers

  • LIBRIS-ID:oai:DiVA.org:uu-194755
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-194755URI
  • https://doi.org/10.1373/clinchem.2011.180778DOI

Supplementary language notes

  • Language:English
  • Summary in:English

Part of subdatabase

Classification

  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • A major application of tumor biomarkers is in serial monitoring of cancer patients, but there are no published guidelines on how to evaluate biomarkers for this purpose. The European Group on Tumor Markers has convened a multidisciplinary panel of scientists to develop guidance on the design of such monitoring trials. The panel proposes a 4-phase model for biomarker-monitoring trials analogous to that in use for the investigation of new drugs. In phase I, biomarker kinetics and correlation with tumor burden are assessed. Phase II evaluates the ability of the biomarker to identify, exclude, and/or predict a change in disease status. In phase III, the effectiveness of tumor biomarker guided intervention is assessed by measuring patient outcome in randomized trials. Phase IV consists of an audit of the long-term effects after biomarker monitoring has been included into standard patient care. Systematic well-designed evaluations of biomarkers for monitoring may provide a stronger evidence base that might enable their earlier use in evaluating responses to cancer therapy.

Added entries (persons, corporate bodies, meetings, titles ...)

  • Duffy, Michael J. (author)
  • Hayes, Daniel F. (author)
  • Sturgeon, Catharine M. (author)
  • Barak, Vivian (author)
  • Bossuyt, Patrick M. (author)
  • Diamandis, Eleftherios P. (author)
  • Gion, Massimo (author)
  • Hyltoft-Petersen, Per (author)
  • Lamerz, Rolf M. (author)
  • Nielsen, Dorte L. (author)
  • Sibley, Paul (author)
  • Tholander, BengtUppsala universitet,Enheten för onkologi(Swepub:uu)betho227 (author)
  • Tuxen, Malgorzata K. (author)
  • Bonfrer, Johannes M. G. (author)
  • Uppsala universitetEnheten för onkologi (creator_code:org_t)

Related titles

  • In:Clinical Chemistry: Oxford University Press (OUP)59:1, s. 52-590009-91471530-8561

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