Performance of a Multigene Genomic Classifier in Thyroid Nodules With Indeterminate Cytology: A Prospective Blinded Multicenter Study. (Record no. 3901)

MARC details
000 -LEADER
fixed length control field 04545nam a22005537a 4500
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 181116s20192019 xxu||||| |||| 00| 0 eng d
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER
International Standard Serial Number 2374-2437
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code 10.1001/jamaoncol.2018.4616 [doi]
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code 2713846 [pii]
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
PMID 30419129
245 ## - TITLE STATEMENT
Title Performance of a Multigene Genomic Classifier in Thyroid Nodules With Indeterminate Cytology: A Prospective Blinded Multicenter Study.
251 ## - Source
Source Neonatology. 115(2):108-115, 2019.
252 ## - Abbreviated Source
Abbreviated source Neonatology. 115(2):108-115, 2019.
253 ## - Journal Name
Journal name JAMA oncology
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Year 2019
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Manufacturer FY2019
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE]
Publication status aheadofprint
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE]
Publication status ppublish
266 ## - Date added to catalog
Date added to catalog 2018-11-16
520 ## - SUMMARY, ETC.
Abstract Conclusions 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 ## - SUMMARY, ETC.
Abstract Design, 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 ## - SUMMARY, ETC.
Abstract Importance: 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 ## - SUMMARY, ETC.
Abstract Interventions: A total of 286 FNA samples from thyroid nodules underwent molecular analysis using the multigene GC (ThyroSeq v3).
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Abstract Main 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 ## - SUMMARY, ETC.
Abstract Objective: To determine the diagnostic accuracy of a multigene classifier (GC) test (ThyroSeq v3) for cytologically indeterminate thyroid nodules.
520 ## - SUMMARY, ETC.
Abstract Results: 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 ## - LANGUAGE NOTE
Language note English
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Topical term or geographic name entry element *Drugs, Generic/sd [Supply & Distribution]
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Topical term or geographic name entry element *Intensive Care Units, Neonatal/sn [Statistics & Numerical Data]
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Topical term or geographic name entry element *Intensive Care, Neonatal/st [Standards]
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Topical term or geographic name entry element *Prescription Drugs/sd [Supply & Distribution]
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Topical term or geographic name entry element Humans
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Topical term or geographic name entry element Infant, Newborn
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Topical term or geographic name entry element Intensive Care Units, Neonatal/td [Trends]
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Topical term or geographic name entry element Intensive Care, Neonatal/og [Organization & Administration]
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Topical term or geographic name entry element Neonatologists
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Topical term or geographic name entry element United States
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Institution MedStar Washington Hospital Center
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Department Medicine/Endocrinology
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Medline publication type Journal Article
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Local Authors Burman, Kenneth D
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Local Authors Chiosea, Simion I
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Local Authors Gomes-Lima, Cristiane
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Kundra, Priya
790 ## - Authors
All authors Baloch 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 ## - ELECTRONIC LOCATION AND ACCESS
DOI <a href="https://dx.doi.org/10.1001/jamaoncol.2018.4616">https://dx.doi.org/10.1001/jamaoncol.2018.4616</a>
Public note https://dx.doi.org/10.1001/jamaoncol.2018.4616
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
Item type description Article
Holdings
Withdrawn status Lost status Damaged status Not for loan Collection Home library Current library Date acquired Total Checkouts Full call number Barcode Date last seen Price effective from Koha item type
          MedStar Authors Catalog MedStar Authors Catalog 11/16/2018   30419129 30419129 11/16/2018 11/16/2018 Journal Article

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