51. Clinical validation of 13-gene DNA methylation analysis in oral brushing samples for detection of oral carcinoma: an Italian multicenter study
- Author
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Antonia Marcianò, Daniela Adamo, Rodolfo Mauceri, Salvatore Crimi, Paolo Vescovi, Lucio Montebugnoli, Michele D. Mignogna, Alberto Bianchi, Dario Di Stasio, Achille Tarsitano, Maria Pia Foschini, Marco Meleti, Claudio Marchetti, Andrea Santarelli, Luca Morandi, Giuseppina Campisi, Roberto De Luca, Umberto Romeo, Davide Bartolomeo Gissi, Monica Pentenero, Giacomo Oteri, Gianluca Tenore, Giuseppe Colella, Rosario Serpico, Gissi, D. B., Morandi, L., Colella, G., De Luca, R., Campisi, G., Mauceri, R., Romeo, U., Tenore, G., Mignogna, M. D., Adamo, D., Oteri, G., Marciano, A., Vescovi, P., Meleti, M., Serpico, R., Di Stasio, D., Pentenero, M., Santarelli, A., Bianchi, A., Crimi, S., Marchetti, C., Tarsitano, A., Foschini, M. P., Montebugnoli, L., Gissi D.B., Morandi L., Colella G., De Luca R., Campisi G., Mauceri R., Romeo U., Tenore G., Mignogna M.D., Adamo D., Oteri G., Marciano A., Vescovi P., Meleti M., Serpico R., Di Stasio D., Pentenero M., Santarelli A., Bianchi A., Crimi S., Marchetti C., Tarsitano A., Foschini M.P., and Montebugnoli L.
- Subjects
0301 basic medicine ,medicine.medical_specialty ,Bisulfite sequencing ,algorithm ,bisulfite sequencing ,diagnostic test ,oral brushing ,oral squamous cell carcinoma ,quantitative DNA methylation analysis ,Gastroenterology ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Healthy volunteers ,Carcinoma ,medicine ,Humans ,Mouth neoplasm ,business.industry ,DNA Methylation ,medicine.disease ,Dna amplification ,stomatognathic diseases ,030104 developmental biology ,Italy ,Otorhinolaryngology ,Multicenter study ,Head and Neck Neoplasms ,030220 oncology & carcinogenesis ,DNA methylation ,Carcinoma, Squamous Cell ,Mouth Neoplasms ,business ,Oral medicine - 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.
- Published
- 2021