Evaluating molecular biomarkers for the early detection of lung cancer: When is a biomarker ready for clinical use? An official American Thoracic Society Policy Statement

Peter J. Mazzone, Catherine Sears, Doug A. Arenberg, Mina Gaga, Michael K. Gould, Pierre P. Massion, Vish S. Nair, Charles A. Powell, Gerard A. Silvestri, Anil Vachani, Renda Soylemez Wiener

Research output: Contribution to journalReview article

18 Citations (Scopus)

Abstract

Background: Molecular biomarkers have the potential to improve the current state of early lung cancer detection. The goal of this project was to develop a policy statement that provides guidance about the level of evidence required to determine that a molecular biomarker, used to support early lung cancer detection, is appropriate for clinical use. Methods: An ad hoc project steering committee was formed, to include individuals with expertise in the early detection of lung cancer and molecular biomarker development, from inside and outside of the Assembly on Thoracic Oncology. Key questions, generated from the results of a survey of the project steering committee, were discussed at an in-person meeting. Results of the discussion were summarized in a policy statement that was circulated to the steering committee and revised multiple times to achieve consensus. Results: With a focus on the clinical applications of lung cancer screening and lung nodule evaluation, the policy statement outlines categories of results that should be reported in the early phases of molecular biomarker development, discusses the level of evidence that would support study of the clinical utility, describes the outcomes that should be proven to consider a molecular biomarker clinically useful, and suggests study designs capable of assessing these outcomes. Conclusions: The application of molecular biomarkers to assist with the early detection of lung cancer has the potential to substantially improve our ability to select patients for lung cancer screening, and to assist with the characterization of indeterminate lung nodules. We have described relevant considerations and have suggested standards to apply when determining whether a molecular biomarker for the early detection of lung cancer is ready for clinical use.

Original languageEnglish (US)
Pages (from-to)e15-e29
JournalAmerican Journal of Respiratory and Critical Care Medicine
Volume196
Issue number7
DOIs
StatePublished - Oct 1 2017
Externally publishedYes

Fingerprint

Early Detection of Cancer
Lung Neoplasms
Biomarkers
Tumor Biomarkers
Thorax
Lung

Keywords

  • Clinical utility
  • Lung cancer screening
  • Lung nodules
  • Outcomes
  • Study design

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Critical Care and Intensive Care Medicine

Cite this

Evaluating molecular biomarkers for the early detection of lung cancer : When is a biomarker ready for clinical use? An official American Thoracic Society Policy Statement. / Mazzone, Peter J.; Sears, Catherine; Arenberg, Doug A.; Gaga, Mina; Gould, Michael K.; Massion, Pierre P.; Nair, Vish S.; Powell, Charles A.; Silvestri, Gerard A.; Vachani, Anil; Wiener, Renda Soylemez.

In: American Journal of Respiratory and Critical Care Medicine, Vol. 196, No. 7, 01.10.2017, p. e15-e29.

Research output: Contribution to journalReview article

Mazzone, Peter J. ; Sears, Catherine ; Arenberg, Doug A. ; Gaga, Mina ; Gould, Michael K. ; Massion, Pierre P. ; Nair, Vish S. ; Powell, Charles A. ; Silvestri, Gerard A. ; Vachani, Anil ; Wiener, Renda Soylemez. / Evaluating molecular biomarkers for the early detection of lung cancer : When is a biomarker ready for clinical use? An official American Thoracic Society Policy Statement. In: American Journal of Respiratory and Critical Care Medicine. 2017 ; Vol. 196, No. 7. pp. e15-e29.
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