Research Papers:

Comparative analysis of diagnostic performance, feasibility and cost of different test-methods for thyroid nodules with indeterminate cytology

Salvatore Sciacchitano _, Luca Lavra, Alessandra Ulivieri, Fiorenza Magi, Gian Paolo De Francesco, Carlo Bellotti, Leila B. Salehi, Maria Trovato, Carlo Drago and Armando Bartolazzi

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Oncotarget. 2017; 8:49421-49442. https://doi.org/10.18632/oncotarget.17220

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Salvatore Sciacchitano1,2, Luca Lavra2, Alessandra Ulivieri2, Fiorenza Magi2, Gian Paolo De Francesco3, Carlo Bellotti4, Leila B. Salehi2,5, Maria Trovato6, Carlo Drago7 and Armando Bartolazzi8,9

1Department of Clinical and Molecular Medicine, Sapienza University, 00161 Rome, Italy

2Laboratory of Biomedical Research, Niccolò Cusano University Foundation, 00166 Rome, Italy

3Department of Oncological Science, Breast Unit, St Andrea University Hospital, 00189 Rome, Italy

4Operative Unit Surgery of Thyroid and Parathyroid, Sapienza University of Rome, St Andrea Hospital, 00189 Rome, Italy

5Department of Biopathology and Diagnostic Imaging, Tor Vergata University, 00133 Rome, Italy

6Department of Clinical and Experimental Medicine, Pad D 2° piano-AOU Policlinico “G. Martino”, 98125 Messina, Italy

7Department of Economics, Niccolò Cusano University, 00166 Rome, Italy

8Laboratory of Surgical and Experimental Pathology, St Andrea University Hospital, 00189 Rome, Italy

9Department of Oncology-Pathology, Cancer Center Karolinska Universitetssjukhuset Solna, S-17176 Stockholm, Sweden

Correspondence to:

Salvatore Sciacchitano, email: [email protected]

Keywords: thyroid FNA cytology, indeterminate thyroid nodules, systematic review, meta-analysis, diagnostic performance

Received: January 27, 2017     Accepted: March 22, 2017     Published: April 19, 2017


Since it is impossible to recognize malignancy at fine needle aspiration (FNA) cytology in indeterminate thyroid nodules, surgery is recommended for all of them. However, cancer rate at final histology is <30%. Many different test-methods have been proposed to increase diagnostic accuracy in such lesions, including Galectin-3-ICC (GAL-3-ICC), BRAF mutation analysis (BRAF), Gene Expression Classifier (GEC) alone and GEC+BRAF, mutation/fusion (M/F) panel, alone, M/F panel+miRNA GEC, and M/F panel by next generation sequencing (NGS), FDG-PET/CT, MIBI-Scan and TSHR mRNA blood assay.

We performed systematic reviews and meta-analyses to compare their features, feasibility, diagnostic performance and cost. GEC, GEC+BRAF, M/F panel+miRNA GEC and M/F panel by NGS were the best in ruling-out malignancy (sensitivity = 90%, 89%, 89% and 90% respectively). BRAF and M/F panel alone and by NGS were the best in ruling-in malignancy (specificity = 100%, 93% and 93%). The M/F by NGS showed the highest accuracy (92%) and BRAF the highest diagnostic odds ratio (DOR) (247). GAL-3-ICC performed well as rule-out (sensitivity = 83%) and rule-in test (specificity = 85%), with good accuracy (84%) and high DOR (27) and is one of the cheapest (113 USD) and easiest one to be performed in different clinical settings.

In conclusion, the more accurate molecular-based test-methods are still expensive and restricted to few, highly specialized and centralized laboratories. GAL-3-ICC, although limited by some false negatives, represents the most suitable screening test-method to be applied on a large-scale basis in the diagnostic algorithm of indeterminate thyroid lesions.

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