Impact of the Afirma Gene Expression Classifier Result on the Surgical Management of Thyroid Nodules with Category III/IV Cytology and Its Correlation with Surgical Outcome

2016 ◽  
Vol 60 (3) ◽  
pp. 205-210 ◽  
Author(s):  
Shweta Chaudhary ◽  
Yanjun Hou ◽  
Rulong Shen ◽  
Shveta Hooda ◽  
Zaibo Li
Keyword(s):  
Gene Expression ◽  
Predictive Value ◽  
Surgical Outcome ◽  
Thyroid Nodules ◽  
Needle Aspiration ◽  
Follicular Neoplasm ◽  
Molecular Test ◽  
Gene Expression Classifier ◽  
Sensitivity Specificity ◽  
Undetermined Significance

Objective: The Afirma gene expression classifier (GEC) is a molecular test to further classify indeterminate fine-needle aspiration (FNA) as benign or suspicious for malignancy. Study Design: A total of 158 FNAs with Bethesda category III/IV cytology were sent for an Afirma GEC test. We correlated the Afirma GEC results with surgical outcome and also compared the data after Afirma's implementation with the data before. Results: Among the 158 FNAs, the Afirma result was benign in 63 (40%), suspicious in 85 (54%) and unsatisfactory in 10 (6%). In total, 73 (86%) suspicious Afirma cases had surgery and 28 (38%) showed carcinoma. In contrast, only 8 (13%) benign Afirma cases had surgery and all of them were benign. The sensitivity, specificity, negative predictive value and positive predictive value (PPV) of Afirma were 100, 15, 100 and 38%, respectively. The PPV was 20% in cases with follicular lesion of undetermined significance, but was 50% in cases suspicious for follicular neoplasm (SFN). The surgical excisional rate was significantly decreased in SFN cases after the Afirma test. Conclusions: The Afirma GEC is useful for further risk stratifying SFN cases.

Diagnostic Accuracy of Fine Needle Aspiration in Thyroid Nodules Arising in Patients with Graves Disease

2017 ◽  
Vol 61 (2) ◽  
pp. 117-124 ◽  
Author(s):  
Jen-Fan Hang ◽  
Mohammed T. Lilo ◽  
Justin A. Bishop ◽  
Syed Z. Ali
Keyword(s):  
Predictive Value ◽  
Thyroid Nodules ◽  
Follicular Adenoma ◽  
Clinical Information ◽  
Needle Aspiration ◽  
Follicular Neoplasm ◽  
Graves Disease ◽  
Fine Needle ◽  
Cellular Atypia ◽  
Sensitivity Specificity

Objective: Cytopathologic interpretation in Graves disease (GD) is considered challenging due to significant cellular atypia. Study Design: We retrospectively identified 55 fine needle aspirations (FNAs) from 43 patients with GD that subsequently underwent thyroidectomy from 1995 to 2016. Results: There were 5 patients with papillary thyroid carcinoma (PTC) and 4 with follicular adenoma (FA). Of the 5 patients with PTC, FNA was interpreted as PTC in 3, atypia of undetermined significance (AUS) in 1, and adenomatoid nodule (AN) in 1 (with a 0.5-cm incidental microcarcinoma). Of the 4 patients with FA, FNA was interpreted as follicular neoplasm (FN) in 2, AUS in 1, and AN in 1. Of the 46 nonneoplastic nodules, FNA was interpreted as nondiagnostic in 2, benign in 26, AUS in 15, FN in 1, and suspicious for PTC in 2. None was diagnosed as malignant. The sensitivity, specificity, positive predictive value, and negative predictive value of PTC diagnosis in FNA were 60, 100, 100, and 96.2%, respectively. Conclusion: FNA is a useful tool for identifying neoplastic nodules arising in GD. However, cytologic atypia often leads to indeterminate diagnoses (18/46, 39.1%). Awareness of clinical information regarding prior treatment for GD may be helpful to avoid overinterpretation.

The Bethesda System for Reporting Thyroid Fine-Needle Aspiration Cytology: A Kuwaiti Experience - A Cytohistopathological Study of 374 Cases

2015 ◽  
Vol 59 (2) ◽  
pp. 133-138 ◽  
Author(s):  
Kusum Kapila ◽  
Laila Qadan ◽  
Rola H. Ali ◽  
Mohammed Jaragh ◽  
Sara S. George ◽  
...  
Keyword(s):  
Predictive Value ◽  
Needle Aspiration ◽  
Follicular Neoplasm ◽  
Thyroid Fine Needle Aspiration ◽  
Risk Of Malignancy ◽  
Bethesda System ◽  
Needle Aspiration Cytology ◽  
Sensitivity Specificity ◽  
The Bethesda System ◽  
Undetermined Significance

Introduction: The Bethesda System for Reporting Thyroid Cytopathology (TBSRTC) identifies 6 diagnostic categories in which the risk of malignancy increases respectively. The aim of our study was to assess TBSRTC reporting in our hospital and to evaluate its specificity based on cytohistological correlation. Methods: A histological diagnosis was available in 374 (110 males and 264 females) out of 7,809 thyroid aspirates examined at Mubarak Al-Kabeer Hospital, Kuwait, from 2004 to 2012. The aspirates were classified in accordance with TBSRTC. Results: Thyroid aspirates were classified as nondiagnostic (n = 18; 4.8%), benign (n = 114; 30.5%); atypia of undetermined significance/follicular lesion of undetermined significance (AUS/FLUS; n = 59; 15.8%), follicular neoplasm/suspicious for follicular neoplasm (FN/SFN; n = 17; 4.5%), suspicious for malignancy (SM; n = 80; 21.4%), or malignant (n = 86; 23.0%). In 75 of 86 malignant cases, a papillary carcinoma was detected. There were 3 (1.6%) false-positive aspirates and the sensitivity, specificity, negative predictive value, and positive predictive value were 91.0, 61.9, 84.2, and 75.3%, respectively. Conclusions: Our results are fairly comparable to those of various previous studies in the SM, AUS/FLUS, and SFN categories. The higher rates observed in the nondiagnostic and benign categories were possibly due to limited guided aspirations and a lack of on-site evaluation for all cases.

scholarly journals Thyroid Cytopathology Reporting by the Bethesda System: A Two-Year Prospective Study in an Academic Institution

2015 ◽  
Vol 2015 ◽  
pp. 1-11 ◽  
Author(s):  
Payal Mehra ◽  
Anand Kumar Verma
Keyword(s):  
Prospective Study ◽  
Predictive Value ◽  
Thyroid Nodules ◽  
Needle Aspiration ◽  
Follicular Neoplasm ◽  
Fine Needle ◽  
Bethesda System ◽  
Thyroid Cytopathology ◽  
The Bethesda System ◽  
Undetermined Significance

Background. The Bethesda System for Reporting Thyroid Cytopathology (TBSRTC) has attempted to standardize reporting and cytological criteria in aspiration smears. Aims. The objective of this study was to analyze the thyroid cytology smears by TBSRTC, to determine the distribution of diagnostic categories and subcategories, to analyze cytological features, and to correlate the cytopathology with histopathology, wherever surgery was done. Materials and Methods. This was a prospective study of 225 fine needle aspirations (FNA) of thyroid nodules. All fine needle aspiration cytology (FNAC) diagnoses were classified according to the features given in the monograph of TBSRTC into nondiagnostic/unsatisfactory (ND/UNS), benign, atypia of undetermined significance/follicular lesion of undetermined significance (AUS/FLUS), follicular neoplasm/suspicious of a follicular neoplasm (FN/SFN), suspicious for malignancy (SFM), and malignant. Cytohistological correlation was done, when surgical material was available. Results. The distribution of various categories from 225 evaluated thyroid nodules was as follows: 7.2% ND/UNS, 80.0% benign, 4.9% AUS/FLUS, 2.2% FN, 3.5% SFM, and 2.2% malignant. Sensitivity, specificity, positive predictive value, and negative predictive value were calculated. Conclusions. TBSRTC is an excellent reporting system for thyroid FNA. It also provides clear management guidelines to clinicians to go for follow-up FNA or surgery and also the extent of surgery.

scholarly journals The Diagnostic Performance of Afirma Gene Expression Classifier for the Indeterminate Thyroid Nodules: A Meta-Analysis

2019 ◽  
Vol 2019 ◽  
pp. 1-11
Author(s):  
Ying Liu ◽  
Bihui Pan ◽  
Li Xu ◽  
Da Fang ◽  
Xianghua Ma ◽  
...  
Keyword(s):  
Gene Expression ◽  
Predictive Value ◽  
Diagnostic Performance ◽  
Thyroid Nodules ◽  
Meta Analysis ◽  
High Sensitivity ◽  
Diagnostic Odds Ratio ◽  
Needle Aspiration ◽  
Summary Receiver Operating Characteristic ◽  
Gene Expression Classifier

Background. Approximately 15 to 30% of thyroid nodules evaluated by fine-needle aspiration (FNA) were classified as indeterminate; the accurate diagnostic molecular tests of these nodules remain a challenge. We aimed to evaluate the diagnostic performance of Afirma gene expression classifier (GEC) for the indeterminate thyroid nodules (ITNs). Methods. Studies published from January 2005 to December 2018 were systematically reviewed. The gold reference standard relied on the histopathologic results diagnosis from thyroidectomy surgical specimens. MetaDisc software was used to investigate the pooled sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), diagnostic odds ratio (DOR), and summary receiver operating characteristic (SROC) curves. Results. A total of 18 studies involving 5290 patients with 3290 cases of ITNs were included. Collected data revealed that the pooled sensitivity of GEC was 95.5% (95% CI 93.3%–97.0%, p < 0.001), the specificity was 22.1% (95% CI 19.4%-24.9%, p < 0.001), the NPV was 88.2% (95% CI 0.833–0.921, p < 0.001), the PPV was 44.3% (95% CI 0.416–0.471, p < 0.001), and the DOR was 5.25 (95% CI 3.42–8.04, p= 0.855). Conclusion. The GEC has quite high sensitivity of 95.5% but low specificity of 22.1%. The high sensitivity makes it probable to rule out malignant nodules. Thus, over half of nodules with GEC-suspicious results still require further validation like molecular markers, diagnostic surgery, or long follow-up, which limits its use in future clinical practice.

scholarly journals An Independent Study of a Gene Expression Classifier (Afirma) in the Evaluation of Cytologically Indeterminate Thyroid Nodules

2014 ◽  
Vol 99 (11) ◽  
pp. 4069-4077 ◽  
Author(s):  
Bryan McIver ◽  
M. Regina Castro ◽  
John C. Morris ◽  
Victor Bernet ◽  
Robert Smallridge ◽  
...  
Keyword(s):  
Gene Expression ◽  
Medical Center ◽  
Academic Medical Center ◽  
Needle Aspiration ◽  
Follicular Neoplasm ◽  
Fine Needle ◽  
Academic Medical ◽  
Gene Expression Classifier ◽  
Thyroid Fine Needle Aspiration ◽  
Undetermined Significance

Context: Molecular markers hold the promise of improved diagnostic yield in thyroid fine-needle biopsy. The Afirma gene expression classifier (GEC), available commercially, reports a negative predictive value of 94% in the diagnosis of benign nodules after indeterminate cytology. However, there are currently no independent studies of the performance of this assay. Objective: The aim was to assess the performance of the Afirma GEC in an academic medical center. Design: Samples for the GEC were collected according to the manufacturer's recommended protocol from patients undergoing thyroid fine-needle aspiration. We requested GEC analysis on nodules reported cytologically as follicular neoplasm or atypia or follicular lesion of undetermined significance from patients willing to defer surgery. Patients: All patients undergoing thyroid fine-needle aspiration during the study period, whose cytology was reported as follicular neoplasm or atypia of undetermined significance/follicular lesion of undetermined significance, were offered access to the test and recruited to this study. Intervention: Patients whose GEC was “benign” were offered ultrasound follow-up in lieu of surgery. Those with a “suspicious” GEC were advised to undergo diagnostic lobectomy. Setting: The study was conducted at a large academic medical center. Main Outcome Measure: We measured the rate of benign and suspicious calls from the Afirma GEC and histological diagnosis after surgery. Results: A total of 72 nucleic acid samples were sent for GEC analysis. In 12 (17%) of these samples, there was insufficient mRNA, leaving 60 Afirma results for analysis. Of these, 16 (27%) were benign, whereas 44 (73%) were suspicious. The rate of confirmed malignancy in GEC-suspicious nodules was only 17%. Conclusion: The Afirma GEC demonstrates a lower than expected rate of benign reports in follicular or Hürthle cell neoplasm and a lower than anticipated malignancy rate within GEC-suspicious nodules. These data suggest that the positive predictive value of the GEC is lower than previously reported and call into question the performance of the test when applied in the context of specialized academic cytopathology.

scholarly journals The value of routine measurement of serum calcitonin on insufficient, indeterminate, and suspicious thyroid nodule cytology

2021 ◽  
Author(s):  
Murat Çalapkulu ◽  
Muhammed Erkam Sencar ◽  
Sema Hepsen ◽  
Hayri Bostan ◽  
Davut Sakiz ◽  
...  
Keyword(s):  
Thyroid Disease ◽  
Thyroid Nodules ◽  
Medullary Thyroid Cancer ◽  
Fine Needle Aspiration Biopsy ◽  
Needle Aspiration ◽  
Follicular Neoplasm ◽  
Serum Calcitonin ◽  
Routine Measurement ◽  
Number Of Patients ◽  
Undetermined Significance

Routine calcitonin measurement in patients with nodular thyroid disease is rather controversial. The aim of this study was to evaluate the contribution of serum calcitonin measurement in the diagnostic evaluation of thyroid nodules with insufficient, indeterminate, or suspicious cytology. Out of 1668 patients who underwent thyroidectomy with the diagnosis of nodular thyroid disease and were screened, 873 patients with insufficient, indeterminate, or suspicious fine needle aspiration biopsy results were included in the study. From the total number of patients in this study, 10 (1.1%) were diagnosed as medullary thyroid cancer (MTC) using histopathology. The calcitonin level was detected to be above the assay-specific cut-off in 23 (2.6%) patients ranging between 6.5 - 4450 pg/mL. While hypercalcitoninemia was detected in all 10 MTC patients, a false positive elevation of serum calcitonin was detected in 13 patients (1.5%). Of the MTC group, 7 patients had cytology results that were suspicious for malignancy (Bethesda V), one patient’s cytology showed atypia of undetermined significance (Bethesda III) and two patient’s cytology results were suspicious for follicular neoplasm (Bethesda IV). Among the cases with non-diagnostic cytology (Bethesda I), none of the patients were diagnosed with MTC. In conclusion, routine serum calcitonin measurement can be performed in selected cases rather than in all nodular thyroid patients. While it is reasonable to perform routine calcitonin measurement in patients with Bethesda IV and Bethesda V, this measurement was not useful in Bethesda I patients. In Bethesda III patients, patient-based decisions can be made according to their calcitonin measurement. Read more in PDF.

scholarly journals Surgical Outcome of Thyroid Nodules with Atypia of Undetermined Significance and Follicular Lesion of Undetermined Significance in Fine Needle Aspiration Biopsy

2017 ◽  
Vol 9 (3) ◽  
pp. 100-103
Author(s):  
Saad Alqahtani ◽  
Saif Alsobhi ◽  
Riyadh I Alsalloum ◽  
Saleh N Najjar ◽  
Hindi N Al-Hindi
Keyword(s):  
Fine Needle Aspiration ◽  
Surgical Outcome ◽  
Thyroid Nodules ◽  
Fine Needle Aspiration Biopsy ◽  
Needle Aspiration ◽  
Aspiration Biopsy ◽  
Fine Needle ◽  
Risk Of Malignancy ◽  
Needle Aspiration Biopsy ◽  
Undetermined Significance

ABSTRACT Aim To correlate selected clinical and ultrasonographic (US) characteristics with the final histopathological diagnosis in patients with atypia of undetermined significance (AUS) and follicular lesion of undetermined significance (FLUS), and whether this information can be used in planning the surgical approach. Materials and methods It is a retrospective study including the operated cases of AUS/FLUS from 2011 to 2014 treated at one center. Results This cohort included 87 women and 28 men. To test for independence between categorical variables, the chi-square test was used. There was no significant correlation between age or US variables and final pathological diagnosis. However, final diagnosis of malignancy was higher in men compared with women (64.3 and 41.4% respectively; p = 0.035). Furthermore, a significant association between the diagnosis of repeated fine needle aspiration biopsy (FNAB) and the final pathological diagnosis was noted (benign vs malignant, p = 0.005). Conclusion The FNAB has a significant role in the assessment of thyroid nodules. Our results showed no correlation between age, US variables, and the risk of malignancy. Male gender is associated with higher risk of malignancy. Clinical significance Determining the risk of malignancy and prediction of surgical outcome may help triaging cases for repeat FNA or proceeding to surgery. How to cite this article Alqahtani S, Alsobhi S, Alsalloum RI, Najjar SN, Al-Hindi HN. Surgical Outcome of Thyroid Nodules with Atypia of Undetermined Significance and Follicular Lesion of Undetermined Significance in Fine Needle Aspiration Biopsy. World J Endoc Surg 2017;9(3):100-103.

scholarly journals Correlation study of thyroid nodule cytopathology and histopathology at two institutions in Jordan

CytoJournal ◽  
2018 ◽  
Vol 15 ◽  
pp. 24 ◽  
Author(s):  
Niveen Abdullah ◽  
Manar Hajeer ◽  
Loay Abudalu ◽  
Maher Sughayer
Keyword(s):  
Test Performance ◽  
Predictive Value ◽  
Diagnostic Category ◽  
Needle Aspiration ◽  
Correlation Study ◽  
Follicular Neoplasm ◽  
Risk Of Malignancy ◽  
Thyroid Fna ◽  
Undetermined Significance

Background: Fine-needle aspiration (FNA) plays a fundamental role in determining the appropriate management for patients presenting with thyroid nodules. Aims: The aims of this study are to evaluate thyroid FNA test performance parameters through a cytohistological correlation. Materials and Methods: A retrospective analysis of all thyroid FNAs received over a period of 18 months was carried out. The findings were compared to their subsequent definite diagnoses on surgical specimens as well as to their follow-up repeat FNA results. A total of 499 thyroid FNAs were collected and reviewed against The Bethesda System for Reporting Thyroid Cytopathology (TBSRTC). The percentage of each diagnostic category was calculated, and the implied risk of malignancy was determined by comparing the cytology results to their definite diagnoses obtained on the resection specimens. Analytical procedures were performed using Microsoft Excel. Results: Out of 499 thyroid FNAs, a benign interpretation was found in 273 patients (54.7%), atypia of undetermined significance in 81 (16.2%), follicular neoplasm in 20 (4%), suspicious for malignancy in 36 (7.2%), malignant in 32 (6.4%) and were nondiagnostic in 57 patients (11.4%). Only 101 patients (20.2%) underwent surgical resection and 47 (9.4%) underwent a follow-up FNA. After cytohistological correlation, FNA test performance, calculated by excluding the inadequate and undetermined categories revealed test sensitivity, specificity, and diagnostic accuracy of 95.6%, 54.8%, and 78.9%, respectively. The positive predictive value was 75.4%, and the negative predictive value was 89.5%. Conclusions: Our results are comparable to those previously published figures. The rate of atypia of undetermined significance/follicular lesion of undetermined significance is higher than what is currently recommended in TBSRTC.

scholarly journals The Bethesda System for Reporting Thyroid Cytopathology: A Cytohistological Study

2020 ◽  
Vol 2020 ◽  
pp. 1-8 ◽  
Author(s):  
Bakiarathana Anand ◽  
Anita Ramdas ◽  
Marie Moses Ambroise ◽  
Nirmal P. Kumar
Keyword(s):  
Positive Predictive Value ◽  
Predictive Value ◽  
Follicular Neoplasm ◽  
Risk Of Malignancy ◽  
Bethesda System ◽  
Sensitivity Specificity ◽  
Thyroid Cytopathology ◽  
The Bethesda System ◽  
Undetermined Significance

Introduction. The Bethesda System for Reporting Thyroid Cytopathology (TBSRTC) is a significant step to standardize the reporting of thyroid fine needle aspiration (FNA). It has high predictive value, reproducibility, and improved clinical significance. Aim. The study was aimed to evaluate the diagnostic utility and reproducibility of “TBSRTC” at our institute. Methods and Material. The study included 646 thyroid FNAs which were reviewed by three pathologists and classified according to TBSRTC. Cytohistological correlation was done for 100 cases with surgical follow-up and the sensitivity, specificity, positive predictive value, negative predictive value, diagnostic accuracy, and risk of malignancy (ROM) were calculated. The interobserver variation among three pathologists was also assessed. Results. The distribution of cases in various TBSRTC categories is as follows: I—nondiagnostic 13.8%, II—benign 75.9%, III—atypia of undetermined significance (AUS)/follicular lesion of undetermined significance (FLUS) 1.2%, IV—follicular neoplasm (FN)/suspicious for follicular neoplasm (SFN) 3.7%, V—suspicious for malignancy (SM) 2.6%, and VI—malignant 2.8%. The sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy are 72.4%, 94.3%, 84%, 89.2%, and 87.9%, respectively. The ROM of various TBSRTC categories were II—8.5%; III—66.7%; IV—63.6%; and V and VI—100%. Cohen’s Weighted Kappa score was 0.99 which indicates almost perfect agreement among the three pathologists. Conclusions. Our study substantiates greater reproducibility among pathologists using TBSRTC to arrive at a precise diagnosis with an added advantage of predicting the risk of malignancy which enables the clinician to plan for follow-up or surgery and also the extent of surgery.

UTILITY OF ULTRASOUND VERSUS GENE EXPRESSION CLASSIFIER IN THYROID NODULES WITH ATYPIA OF UNDETERMINED SIGNIFICANCE

2016 ◽  
Vol 22 (10) ◽  
pp. 1199-1203 ◽  
Author(s):  
Carmen V. Villabona ◽  
Vineeth Mohan ◽  
Karla M. Arce ◽  
Julia Diacovo ◽  
Alisha Aggarwal ◽  
...  
Keyword(s):  
Gene Expression ◽  
Thyroid Nodules ◽  
Versus Gene ◽  
Gene Expression Classifier ◽  
Undetermined Significance
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