ThyroSeq v3 Clinical Validation Details

👉Clinical validation of ThyroSeq v3 performed in the recently completed prospective double-blind multicenter international study (ClinicalTrials.gov identifier NCT02352766). 

👉Patients were enrolled in the study at 10 medical centers, 9 located in the U.S. and 1 in Singapore.

👉Totally, 782 patients with one or more thyroid nodules sampled by FNA (1013 samples) were enrolled.

👉Of those, 257 FNA samples from 234 patients had Bethesda III-V cytology, underwent surgery, and had FNA samples sufficient for molecular analysis.

👉These 257 FNA samples comprised a final validation set that determined ThyroSeq v3 performance.

👉The study had no post-unblinding sample exclusion. 

👉Performance of ThyroSeq v3 in the prospective double-blind multicenter study was recently published in JAMA Oncology. (Steward, DL et al. JAMA Oncol. 2018.) 

👉In this multicenter study, clinical performance of ThyroSeq v3 was validated in all main types of thyroid cancer, including Hurthle cell (oncocytic) cancer.

👉In fact, the study included 10 Hurthle cell carcinomas, 34 Hurthle cell adenomas, and 5 hyperplastic nodules with Hurthle cell predominance. 

👉The performance of ThyroSeq v3 allowed to detect all Hurthle cell carcinomas (sensitivity, 100%; 95%CI:69.2-100%), with all 5 hyperplastic nodules with Hurthle cell predominance classified as Negative, and overall test specificity of 66.7% (95%CI: 49.8-80.9%).

👉In the study, the majority of nodules with false-positive test results were clonal neoplasms and not hyperplastic nodules.

👉There were 5 missed cancers (3%) that were all intrathyroidal and low stage. 

👉Additionally, ThyroSeq performance in Hurthle cell lesions was assessed in an independent study from NYUthat included 188 indeterminate Hurthle cell predominant thyroid FNAs that had ThyroSeq v2/v3 results.

👉Surgical follow up was available for 33 cases:

  • The study found that the majority of cases (61%) were negative by ThyroSeq, meaning ThyroSeq had a 61% negative call rate in Hurthle cell lesions in this study.
  • Five of the ThyroSeq-negative cases went for surgery and all were benign on histology, which means ThyroSeq had 100% NPV for Hurthle cell lesions that went to surgery in this study. 
  • 28 samples were ThyroSeq-positive and went for surgery with 18 diagnosed as cancer or NIFTP on final histology, meaning ThyroSeq had a 64% PPV for cancer/NIFTP in Hurthle cell nodules in this study.
  • 👉Please see the table below for details. 
    • Rodrigo Arrangoiz MS, MD, FACS a head and neck surgeon / endocrine surgeon / surgical oncologist and is a member of Sociedad QuirĂşrgica S.C at the America British Cowdray Medical Center in Mexico City:

     

    prof_739_20190417135234

    • Rodrigo Arrangoiz MS, MD, FACS:
      • Is a member of the American Head and Neck Society

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      • He is a member of the American Thyroid Association:

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    Training:

    • General surgery:

    • Michigan State University:

    • 2004 al 2010

    • Surgical Oncology / Head and Neck Surgery / Endocrine Surgery:

    • Fox Chase Cancer Center (Filadelfia):

    • 2010 al 2012

    • Masters in Science (Clinical research for health professionals):

    • Drexel University (Filadelfia):

    • 2010 al 2012

    • Surgical Oncology / Head and Neck Surgery / Endocrine Surgery:

    • IFHNOS / Memorial Sloan Kettering Cancer Center:

    • 2014 al 2016

     

    #Arrangoiz

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    #ThyroidCancer

    #PapillaryThyroidCancer

    #SurgicalOncologist

    #CirujanoOncologo

    #CancerSurgeon

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    #HeadandNeckSurgeon

    #CirugiaEndocrina

    #CirujanodeTumoresdeCabezayCuello

    #OralCavityCancer

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