{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,11]],"date-time":"2025-11-11T13:11:06Z","timestamp":1762866666964,"version":"build-2065373602"},"reference-count":17,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2015,7,6]],"date-time":"2015-07-06T00:00:00Z","timestamp":1436140800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"VisionGate, LLC"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancer Cytopathology"],"published-print":{"date-parts":[[2015,9]]},"abstract":"<jats:sec><jats:title>BACKGROUND<\/jats:title><jats:p>The LuCED Lung Test comprises an automated 3\u2010dimensional morphologic analysis of epithelial cells in sputum. For each cell, 594 morphology\u2010based features are measured to drive algorithmic classifiers that quantitatively assess whether neoplastic cells are present. The current interim clinical study involves sputum samples from patients with known benign and malignant outcomes to assess the feasibility of LuCED as an adjunctive test after suspicious low\u2010dose computed tomography (LDCT) results or as an independent screening test for lung cancer.<\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS<\/jats:title><jats:p>Sputum samples were fixed, enriched for epithelial cells, and analyzed with a 3\u2010dimensional cell scanner called Cell\u2010CT. Candidate abnormal cells were identified by the classifiers for manual review. The sensitivity, specificity, and negative and positive predictive values were calculated for the detection of neoplastic cases.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>A total of 91 sputum samples from patients with confirmed lung cancer (49 patients) and patients with no known malignancy (42 patients) were evaluated. After cytology review, sensitivity in the positive group was 91.8%, and specificity was 95.2%. Specificity was not 100% because there were 2 cases in which abnormal cells were identified by the Cell\u2010CT that were confirmed as such at the time of manual cytology review. However, at the time of last follow\u2010up, malignancy had not been detected in these 2 cases. Modeling in a population with a 1% prevalence of lung cancer, the positive and negative predictive values would be 95.4% and 99.9%, respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSIONS<\/jats:title><jats:p>LuCED testing is highly sensitive and specific for the detection of lung cancer and has potential value as an adjunctive test after suspicious LDCT findings or as a primary screening test in which LuCED\u2010positive cases would be triaged to diagnostic CT. Further prospective studies currently are underway to evaluate its full usefulness. <jats:bold><jats:italic>Cancer (Cancer Cytopathol)<\/jats:italic> 2015;123:548\u2013556.<\/jats:bold> \u00a9 <jats:italic>2015 American Cancer Society.<\/jats:italic><\/jats:p><\/jats:sec>","DOI":"10.1002\/cncy.21565","type":"journal-article","created":{"date-parts":[[2015,7,6]],"date-time":"2015-07-06T09:18:55Z","timestamp":1436174335000},"page":"548-556","source":"Crossref","is-referenced-by-count":12,"title":["Automated 3\u2010dimensional morphologic analysis of sputum specimens for lung cancer detection: Performance characteristics support use in lung cancer screening"],"prefix":"10.1002","volume":"123","author":[{"given":"David C.","family":"Wilbur","sequence":"first","affiliation":[{"name":"VisionGate Inc Phoenix Arizona"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael G.","family":"Meyer","sequence":"additional","affiliation":[{"name":"VisionGate Inc Phoenix Arizona"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chris","family":"Presley","sequence":"additional","affiliation":[{"name":"VisionGate Inc Phoenix Arizona"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ralph W.","family":"Aye","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology Swedish Hospital Seattle Washington"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul","family":"Zarogoulidis","sequence":"additional","affiliation":[{"name":"Department of Pulmonary Medicine Aristotle University  Thessaloniki Greece"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Douglas W.","family":"Johnson","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology Baptist Cancer Institute Jacksonville Florida"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nir","family":"Peled","sequence":"additional","affiliation":[{"name":"Thoracic Cancer Unit Davidoff Cancer Center, Rabin Medical Center Petach Tiqwa Israel."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alan C.","family":"Nelson","sequence":"additional","affiliation":[{"name":"VisionGate Inc Phoenix Arizona"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2015,7,6]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1159\/000331549"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1309\/AJCP8VE7AWBZCVQT"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/cncy.21576"},{"volume-title":"Cancer Facts and Figures 2015","year":"2015","author":"American Cancer Society","key":"e_1_2_7_5_1"},{"key":"e_1_2_7_6_1","first-page":"649","article-title":"Sputum cytology for the diagnosis of carcinoma of the lung","volume":"26","author":"Pilotti S","year":"1982","journal-title":"Acta Cytol"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1159\/000332531"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.5588\/ijtld.13.0806"},{"volume-title":"National coverage determination (NCD) for screening for lung cancer with low dose computed tomography (LDCT) [press release]","year":"2015","author":"Centers for Medicare & Medicaid Services","key":"e_1_2_7_9_1"},{"key":"e_1_2_7_10_1","unstructured":"Radiology Info.org. Lung Cancer Screening. Oakbrook IL: Radiologic Society of North America\/American College of Radiology; 2015. Available at:http:\/\/www.radiologyinfo.org\/en\/info.cfm?pg=screening\u2010lung. Accessed March 10 2015."},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.7326\/M13-2771"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1102873"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2012.5521"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1093\/biomet\/26.4.404"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.287.18.2382"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.7326\/M14-2086"},{"key":"e_1_2_7_17_1","first-page":"37","article-title":"Diagnosis of bronchial carcinoma on sections of paraffin\u2010embedded sputum. 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