138 chapter 2 Table 17. Baseline characteristics of included studies investigating PAX8/PPARγ rearrangement reference country study design ntot ni included cytology other inclusion and exclusion criteria FNAC sample molecular technique French 2008 USA PS 24 13 (suspicious for) follicular neoplasm TN n.o.s. Thin prep FNAC sample FISH Cantara 2010 Italy PS 235 41 indeterminate TN; histological f/u available additional pre-operative US-FNAC n.o.s. primary and nested PCR amplification Nikiforov 2011 USA PS 1,056 461 Bethesda III or IV TN; FNAC with sufficient epithelial cells and nucleic acids for molecular analysis; histological f/u available residual material and FNAC needle washout miRInform® Thyroid Test Mancini 2012 Italy n.s. 260 48 Thy3 suspicious TN >5mm, FNAC sample positive for thyroglobulin FNAC needle wash-out real-time PCR and FMCA Ohori 2013 USA RS 483 424 Bethesda IV, excluding SHCN/ HCN TN; no Hürthle cell cytology; histological f/u available FNAC needle wash-out miRInform® Thyroid Test BeaudenonHuibregtse 2014 USA PS 806 80 Bethesda III or IV adult with TN ≥1cm; FNAC with sufficient nucleic acids for molecular analysis; correct specimen handling and shipping; no duplicate or contaminated specimen additional FNAC aspirate miRInform® Thyroid Test Eszlinger 2014 (1) Denmark RS 310 164 indeterminate TN; air-dried FNAC slide available; histological f/u and FFPE samples available for mutation analysis air-dried FNAC smears multiplex qPCR Eszlinger 2014 (2) Germany PS 154 125 follicular neoplasm or microfollicular proliferation TN n.o.s. air-dried FNAC smears multiplex qPCR Nikiforov 2014 USA PS 143 143 Bethesda IV TN; sufficient nucleic acids for molecular analysis; histological f/u available residual material from two FNAC passes ThyroSeq® v2 Eszlinger 2015 Italy RS 347 163 Thy3 TN >1cm; histological f/u available air-dried FNAC smears multiplex RT-qPCR and FMCA Giovanella 2015 Switzerland PS 61 61 Bethesda IV adult with solitary cold TN ≥10mm; suspicious on US; normal TSH and calcitonin; histologic f/u available representative archived FNAC slide RT-PCR Nikiforov 2015 USA PS 465 462 Bethesda III TN n.o.s. residual material from 1 or 2 FNAC passes ThyroSeq® v2.1 Valderrabano 2016 USA RS 116 105 Bethesda III or IV TN n.o.s. n.s. miRInform® Thyroid Test TOTAL 4,460 2,290 FFPE: formalin-fixed paraffin embedded. FISH: fluorescence in situ hybridization. FMCA: fluorescence melting curve analysis. f/u: follow-up. ni: total number of indeterminate thyroid nodules included in our analysis. n.o.s.: not otherwise specified. n.s.: not specified. ntot: total number of thyroid nodules in study. PS: prospective. PCR: polymerase chain reaction. qPCR: quantitative PCR. RS: retrospective. RT-PCR: reverse transcription PCR. SHCN/HCN: cytology (suspicious for a) Hürthle cell neoplasm. TN: thyroid nodule.
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