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Multicenter Study
. 2021 May;43(5):1563-1573.
doi: 10.1002/hed.26624. Epub 2021 Jan 28.

Clinical validation of 13-gene DNA methylation analysis in oral brushing samples for detection of oral carcinoma: Italian multicenter study

Davide B Gissi  1 , Luca Morandi  2 , Giuseppe Colella  3 , Roberto De Luca  3 , Giuseppina Campisi  4 , Rodolfo Mauceri  4 , Umberto Romeo  5 , Gianluca Tenore  5 , Michele D Mignogna  6 , Daniela Adamo  6 , Giacomo Oteri  7 , Antonia Marcianò  7 , Paolo Vescovi  8 , Marco Meleti  8 , Rosario Serpico  3 , Dario Di Stasio  3 , Monica Pentenero  9 , Andrea Santarelli  10 , Alberto Bianchi  11 , Salvatore Crimi  11 , Claudio Marchetti  12 , Achille Tarsitano  12 , Maria Pia Foschini  13 , Lucio Montebugnoli  1
Affiliations
Multicenter Study

Clinical validation of 13-gene DNA methylation analysis in oral brushing samples for detection of oral carcinoma: Italian multicenter study

Davide B Gissi et al. Head Neck. 2021 May.

Abstract

Background: The aim of this Italian multicenter study was to evaluate the diagnostic performance of a minimally invasive method for the detection of oral squamous cell carcinoma (OSCC) based on 13-gene DNA methylation analysis in oral brushing samples.

Methods: Oral brushing specimens were collected in 11 oral medicine centers across Italy. Twenty brushing specimens were collected by each center, 10 from patients with OSCC, and 10 from healthy volunteers. DNA methylation analysis was performed in blindness, and each sample was determined as positive or negative based on a predefined cutoff value.

Results: DNA amplification failed in 4 of 220 (1.8%) samples. Of the specimens derived from patients with OSCC, 93.6% (103/110) were detected as positive, and 84.9% (90/106) of the samples from healthy volunteers were negative.

Conclusion: These data confirmed the diagnostic performance of our novel procedure in a large cohort of brushing specimens collected from 11 different centers and analyzed in blindness.

Keywords: algorithm; bisulfite sequencing; diagnostic test; oral brushing; oral squamous cell carcinoma; quantitative DNA methylation analysis.

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References

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