Skip to Main Content

An official website of the United States government

Government Funding Lapse

Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit  cc.nih.gov. Updates regarding government operating status and resumption of normal operations can be found at OPM.gov.

Clinical validation of a blood-based classifier for diagnostic evaluation of asymptomatic individuals with pulmonary nodules.

About this Publication
Title
Clinical validation of a blood-based classifier for diagnostic evaluation of asymptomatic individuals with pulmonary nodules.
Pubmed ID
28694742 (View this publication on the PubMed website)
Publication
Clin Proteomics. 2017; Volume 14: Pages 25
Authors
Birse CE, Tomic JL, Pass HI, Rom WN, Lagier RJ
Affiliations
  • Quest Diagnostics, Research and Development, 33608 Ortega Highway, San Juan Capistrano, CA 92675 USA.
  • Department of Cardiothoracic Surgery, NYU Langone Medical Center, 530 First Avenue, New York, NY 10016 USA.
  • Division of Pulmonary, Critical Care, and Sleep Medicine, NYU School of Medicine, New York, NY 10016 USA.
Abstract

BACKGROUND: The number of pulmonary nodules detected in the US is expected to increase substantially following recent recommendations for nationwide CT-based lung cancer screening. Given the low specificity of CT screening, non-invasive adjuvant methods are needed to differentiate cancerous lesions from benign nodules to help avoid unnecessary invasive procedures in the asymptomatic population. We have constructed a serum-based multi-biomarker panel and assessed its clinical accuracy in a retrospective analysis of samples collected from participants with suspicious radiographic findings in the Prostate, Lung, Chest and Ovarian (PLCO) cancer screening trial.

METHODS: Starting with a set of 9 candidate biomarkers, we identified 8 that exhibited limited pre-analytical variability with increasing clotting time, a key pre-analytical variable associated with the collection of serum. These 8 biomarkers were evaluated in a training study consisting of 95 stage I NSCLC patients and 186 smoker controls where a 5-biomarker pulmonary nodule classifier (PNC) was selected. The clinical accuracy of the PNC was determined in a blinded study of asymptomatic individuals comprising 119 confirmed malignant nodule cases and 119 benign nodule controls selected from the PLCO screening trial.

RESULTS: A PNC comprising 5 biomarkers: CEA, CYFRA 21-1, OPN, SCC, and TFPI, was selected in the training study. In an independent validation study, the PNC resolved lung cancer cases from benign nodule controls with an AUC of 0.653 (p < 0.0001). CEA and CYFRA 21-1, two of the markers included in the PNC, also accurately distinguished malignant lesions from benign controls.

CONCLUSIONS: A 5-biomarker blood test has been developed for the diagnostic evaluation of asymptomatic individuals with solitary pulmonary nodules.

Related CDAS Studies
Related CDAS Projects