{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T02:21:04Z","timestamp":1793326864065,"version":"4.5.0"},"reference-count":20,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2020,5,1]],"date-time":"2020-05-01T00:00:00Z","timestamp":1588291200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2020,5,1]],"date-time":"2020-05-01T00:00:00Z","timestamp":1588291200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Thyroid\u00ae"],"published-print":{"date-parts":[[2020,5]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Although most thyroid nodules with indeterminate cytology are benign, in most of the world, surgery remains as the most frequent diagnostic approach. We have previously reported a 10-gene thyroid genetic classifier, which accurately predicts benign thyroid nodules. The assay is a prototype diagnostic kit suitable for reference laboratory testing and could potentially avoid unnecessary diagnostic surgery in patients with indeterminate thyroid cytology.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Classifier performance was tested in two independent, ethnically diverse, prospective multicenter trials (TGCT-1\/Chile and TGCT-2\/USA). A total of 4061 fine-needle aspirations were collected from 15 institutions, of which 897 (22%) were called indeterminate. The clinical site was blind to the classifier score and the clinical laboratory blind to the pathology report. A matched surgical pathology and valid classifier score was available for 270 samples.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Cohorts showed significant differences, including (i) clinical site patient source (academic, 43% and 97% for TGCT-1 and -2, respectively); (ii) ethnic diversity, with a greater proportion of the Hispanic population (40% vs. 3%) for TGCT-1 and a greater proportion of African American (11% vs. 0%) and Asian (10% vs. 1%) populations for TGCT-2; and (iii) tumor size (mean of 1.7 and 2.5\u2009cm for TGCT-1 and -2, respectively). Overall, there were no differences in the histopathological profile between cohorts. Forty-one of 155 and 45 of 115 nodules were malignant (cancer prevalence of 26% and 39% for TGCT-1 and -2, respectively). The classifier predicted 37 of 41 and 41 of 45 malignant nodules, yielding a sensitivity of 90% [95% confidence interval; CI 77\u201397] and 91% [95% CI 79\u201398] for TGCT-1 and -2, respectively. One hundred one of 114 and 61 of 70 nodules were correctly predicted as benign, yielding a specificity of 89% [95% CI 82\u201394] and 87% [95% CI 77\u201394], respectively. The negative predictive values for TGCT-1 and TGCT-2 were 96% and 94%, respectively, whereas the positive predictive values were 74% and 82%, respectively. The overall accuracy for both cohorts was 89%.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Clinical validation of the classifier demonstrates equivalent performance in two independent and ethnically diverse cohorts, accurately predicting benign thyroid nodules that can undergo surveillance as an alternative to diagnostic surgery.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/thy.2019.0490","type":"journal-article","created":{"date-parts":[[2020,1,7]],"date-time":"2020-01-07T15:48:50Z","timestamp":1578412130000},"page":"704-712","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":32,"title":["A Thyroid Genetic Classifier Correctly Predicts Benign Nodules with Indeterminate Cytology: Two Independent, Multicenter, Prospective Validation Trials"],"prefix":"10.1177","volume":"30","author":[{"given":"Mark","family":"Zafereo","sequence":"first","affiliation":[{"name":"Department of Head and Neck Surgery, University of Texas MD Anderson Cancer Center, Houston, Texas, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bryan","family":"McIver","sequence":"additional","affiliation":[{"name":"Department of Head and Neck\u2013Endocrine Oncology, Moffitt Cancer Center, Tampa, Florida, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sergio","family":"Vargas-Salas","sequence":"additional","affiliation":[{"name":"Department of Surgical Oncology, Pontificia Universidad Cat\u00f3lica de Chile, Santiago, Chile."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9 Miguel","family":"Dom\u00ednguez","sequence":"additional","affiliation":[{"name":"Department of Endocrinology, Pontificia Universidad Cat\u00f3lica de Chile, Santiago, Chile."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David L.","family":"Steward","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology, Head and Neck Surgery; University of Cincinnati Medical Center, Cincinnati, Ohio, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"F. Christopher","family":"Holsinger","sequence":"additional","affiliation":[{"name":"Division of Head and Neck Surgery, Department of Otolaryngology; Palo Alto, California, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emad","family":"Kandil","sequence":"additional","affiliation":[{"name":"Department of Surgery, School of Medicine, Tulane University, New Orleans, Louisiana, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelle","family":"Williams","sequence":"additional","affiliation":[{"name":"Division of Pathology\/Lab Medicine, Department of Pathology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francisco","family":"Cruz","sequence":"additional","affiliation":[{"name":"Department of Radiology, Faculty of Medicine, Pontificia Universidad Catolica de Chile, Santiago, Chile."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Soledad","family":"Loyola","sequence":"additional","affiliation":[{"name":"Department of Radiology, Faculty of Medicine, Pontificia Universidad Catolica de Chile, Santiago, Chile."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonieta","family":"Solar","sequence":"additional","affiliation":[{"name":"Department of Pathology, Faculty of Medicine, Pontificia Universidad Catolica de Chile, Santiago, Chile."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan Carlos","family":"Roa","sequence":"additional","affiliation":[{"name":"Department of Pathology, Faculty of Medicine, Pontificia Universidad Catolica de Chile, Santiago, Chile."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Augusto","family":"Le\u00f3n","sequence":"additional","affiliation":[{"name":"Department of Surgical Oncology, Pontificia Universidad Cat\u00f3lica de Chile, Santiago, Chile."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicol\u00e1s","family":"Droppelman","sequence":"additional","affiliation":[{"name":"Department of Surgical Oncology, Pontificia Universidad Cat\u00f3lica de Chile, Santiago, Chile."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maite","family":"Lobos","sequence":"additional","affiliation":[{"name":"Centro Diagnostico Plaza Italia, Santiago, Chile."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatiana","family":"Arias","sequence":"additional","affiliation":[{"name":"Clinica UC San Carlos, Santiago, Chile."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina S.","family":"Kong","sequence":"additional","affiliation":[{"name":"Department of Pathology; Stanford University, Palo Alto, California, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naifa","family":"Busaidy","sequence":"additional","affiliation":[{"name":"Department of Endocrine Neoplasia, University of Texas MD Anderson Cancer Center, Houston, Texas, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth G.","family":"Grubbs","sequence":"additional","affiliation":[{"name":"Department of Surgical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Graham","sequence":"additional","affiliation":[{"name":"Department of Surgical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Stewart","sequence":"additional","affiliation":[{"name":"Division of Pathology\/Lab Medicine, Department of Pathology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alice","family":"Tang","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology, Head and Neck Surgery; 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