Audit of the autoantibody test, EarlyCDT®-Lung, in 1600 patients: An evaluation of its performance in routine clinical practice

Jett, James R.; Peek, Laura J.; Fredericks, Lynn; Jewell, William; Pingleton, William W.; ROBERTSON, JOHN

Abstract

Objectives
EarlyCDT®-Lung may enhance detection of early stage lung cancer by aiding physicians in assessing high-risk patients through measurement of biological markers (i.e., autoantibodies). The test's performance characteristics in routine clinical practice were evaluated by auditing clinical outcomes of 1613 US patients deemed at high risk for lung cancer by their physician, who ordered the EarlyCDT-Lung test for their patient.
Methods
Clinical outcomes for all 1613 patients who provided HIPAA authorization are reported. Clinical data were collected from each patient's treating physician. Pathology reports when available were reviewed for diagnostic classification. Staging was assessed on histology, otherwise on imaging.
Results
Six month follow-up for the positives/negatives was 99%/93%. Sixty-one patients (4%) were identified with lung cancer, 25 of whom tested positive by EarlyCDT-Lung (sensitivity = 41%). A positive EarlyCDT-Lung test on the current panel was associated with a 5.4-fold increase in lung cancer incidence versus a negative. Importantly, 57% (8/14) of non-small cell lung cancers detected as positive (where stage was known) were stage I or II.
Conclusions
EarlyCDT-Lung has been extensively tested and validated in case–control settings and has now been shown in this audit to perform in routine clinical practice as predicted. EarlyCDT-Lung may be a complementary tool to CT for detection of early lung cancer.

Citation

Jett, J. R., Peek, L. J., Fredericks, L., Jewell, W., Pingleton, W. W., & ROBERTSON, J. (2014). Audit of the autoantibody test, EarlyCDT®-Lung, in 1600 patients: An evaluation of its performance in routine clinical practice. Lung Cancer, 83(1), 51-55. https://doi.org/10.1016/j.lungcan.2013.10.008

• Journal Article Type: Article
• Acceptance Date: Oct 14, 2013
• Online Publication Date: Nov 25, 2013
• Publication Date: Jan 1, 2014
• Deposit Date: Sep 8, 2017
• Publicly Available Date: Aug 3, 2020
• Journal: Lung Cancer
• Electronic ISSN: 1872-8332
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 83
• Issue: 1
• Pages: 51-55
• DOI: https://doi.org/10.1016/j.lungcan.2013.10.008
• Public URL: https://nottingham-repository.worktribe.com/output/1118295
• Publisher URL: https://www.lungcancerjournal.info/article/S0169-5002(13)00452-2/fulltext
• PMID: 00033015