| 000 | 04545nam a22005537a 4500 | ||
|---|---|---|---|
| 008 | 181116s20192019 xxu||||| |||| 00| 0 eng d | ||
| 022 | _a2374-2437 | ||
| 024 | _a10.1001/jamaoncol.2018.4616 [doi] | ||
| 024 | _a2713846 [pii] | ||
| 040 | _aOvid MEDLINE(R) | ||
| 099 | _a30419129 | ||
| 245 | _aPerformance of a Multigene Genomic Classifier in Thyroid Nodules With Indeterminate Cytology: A Prospective Blinded Multicenter Study. | ||
| 251 | _aNeonatology. 115(2):108-115, 2019. | ||
| 252 | _aNeonatology. 115(2):108-115, 2019. | ||
| 253 | _aJAMA oncology | ||
| 260 | _c2019 | ||
| 260 | _fFY2019 | ||
| 265 | _saheadofprint | ||
| 265 | _sppublish | ||
| 266 | _d2018-11-16 | ||
| 520 | _aConclusions and Relevance: In this prospective, blinded, multicenter study, the multigene GC test demonstrated a high sensitivity/NPV and reasonably high specificity/PPV, which may obviate diagnostic surgery in up to 61% of patients with Bethesda III to IV indeterminate nodules, and up to 82% of all benign nodules with indeterminate cytology. Information on specific genetic alterations obtained from FNA may help inform individualized treatment of patients with a positive test result. | ||
| 520 | _aDesign, Setting, and Participants: Prospective, blinded cohort study conducted at 10 medical centers, with 782 patients with 1013 nodules enrolled. Eligibility criteria were met in 256 patients with 286 nodules; central pathology review was performed on 274 nodules. | ||
| 520 | _aImportance: Approximately 20% of fine-needle aspirations (FNA) of thyroid nodules have indeterminate cytology, most frequently Bethesda category III or IV. Diagnostic surgeries can be avoided for these patients if the nodules are reliably diagnosed as benign without surgery. | ||
| 520 | _aInterventions: A total of 286 FNA samples from thyroid nodules underwent molecular analysis using the multigene GC (ThyroSeq v3). | ||
| 520 | _aMain Outcomes and Measures: The primary outcome was diagnostic accuracy of the test for thyroid nodules with Bethesda III and IV cytology. The secondary outcome was prediction of cancer by specific genetic alterations in Bethesda III to V nodules. | ||
| 520 | _aObjective: To determine the diagnostic accuracy of a multigene classifier (GC) test (ThyroSeq v3) for cytologically indeterminate thyroid nodules. | ||
| 520 | _aResults: Of the 286 cytologically indeterminate nodules, 206 (72%) were benign, 69 (24%) malignant, and 11 (4%) noninvasive follicular thyroid neoplasms with papillary-like nuclei (NIFTP). A total of 257 (90%) nodules (154 Bethesda III, 93 Bethesda IV, and 10 Bethesda V) had informative GC analysis, with 61% classified as negative and 39% as positive. In Bethesda III and IV nodules combined, the test demonstrated a 94% (95% CI, 86%-98%) sensitivity and 82% (95% CI, 75%-87%) specificity. With a cancer/NIFTP prevalence of 28%, the negative predictive value (NPV) was 97% (95% CI, 93%-99%) and the positive predictive value (PPV) was 66% (95% CI, 56%-75%). The observed 3% false-negative rate was similar to that of benign cytology, and the missed cancers were all low-risk tumors. Among nodules testing positive, specific groups of genetic alterations had cancer probabilities varying from 59% to 100%. | ||
| 546 | _aEnglish | ||
| 650 | _a*Drugs, Generic/sd [Supply & Distribution] | ||
| 650 | _a*Intensive Care Units, Neonatal/sn [Statistics & Numerical Data] | ||
| 650 | _a*Intensive Care, Neonatal/st [Standards] | ||
| 650 | _a*Prescription Drugs/sd [Supply & Distribution] | ||
| 650 | _aHumans | ||
| 650 | _aInfant, Newborn | ||
| 650 | _aIntensive Care Units, Neonatal/td [Trends] | ||
| 650 | _aIntensive Care, Neonatal/og [Organization & Administration] | ||
| 650 | _aNeonatologists | ||
| 650 | _aUnited States | ||
| 651 | _aMedStar Washington Hospital Center | ||
| 656 | _aMedicine/Endocrinology | ||
| 657 | _aJournal Article | ||
| 700 | _aBurman, Kenneth D | ||
| 700 | _aChiosea, Simion I | ||
| 700 | _aGomes-Lima, Cristiane | ||
| 700 | _aKundra, Priya | ||
| 790 | _aBaloch ZW, Burman KD, Carty SE, Chiosea SI, Ferris RL, Figge JJ, Folek JM, Gomes-Lima C, Gooding WE, Haugen BR, Khawaja RA, Kundra P, Lloyd RV, Loh KS, Mandel S, Marshall CB, Mayson S, McCoy KL, Nga ME, Ngiam KY, Nikiforov YE, Nikiforova MN, Poehls JL, Ringel MD, Seethala RR, Sipos JA, Sippel RS, Sosa JA, Steward DL, Yang H, Yang SP, Yip L | ||
| 856 |
_uhttps://dx.doi.org/10.1001/jamaoncol.2018.4616 _zhttps://dx.doi.org/10.1001/jamaoncol.2018.4616 |
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| 942 |
_cART _dArticle |
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| 999 |
_c3901 _d3901 |
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