Clinical Validation of 13-gene DNA Methylation Analysis from Oral Brushing: A Non Invasive Sampling Procedure for Early Detection of Oral Squamous Cell Carcinoma. A Multicentric Study †
by
, , , and
Davide B. Gissi
1,*
,
Umberto Romeo
2,
Gianluca Tenore
2, 
Monica Pentenero
3,
Giuseppina Campisi
4, 
Rodolfo Mauceri
4,
Giuseppe Colella
5,
Roberto De Luca
5,
Rosario Serpico
6,
Dario Di Stasio
6, 
Giacomo Oteri
7,
Paolo Vescovi
8,
Michele D. Mignogna
9,
Noemi Coppola
9,
Andrea Santarelli
10,
Luca Morandi
11 and
Lucio Montebugnoli
1 1
Department of Biomedical and Neuromotor Sciences, Section of Oral Sciences, University of Bologna, 40159 Bologna, Italy
2
Department of Oral and Maxillofacial Sciences, “Sapienza” University of Rome, 00100 Rome, Italy
3
Oral Medicine and Oral Oncology Unit, Department of Oncology, University of Turin, 10043 Orbassano, Italy
4
Department of Surgical, Oncological and Stomatological Disciplines, Sector of Oral Medicine, University of Palermo, 90127 Palermo, Italy
5
Multidisciplinary department of Medical, Surgical and Dental Specialty, Maxillofacial Surgery Unit, University of Campania “Luigi Vanvitelli”, 80100 Naples, Italy
6
Multidisciplinary Department of Medical-Surgical and Dental Specialties, University of Campania “Luigi Vanvitelli”, 80100 Naples, Italy
7
Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, University Hospital “Gaetano Martino”, 98124 Messina, Italy
8
Department of Medicine and Surgery, Oral Medicine and Laser Surgery Unit, University of Parma, 43100 Parma, Italy
9
Head & Neck Clinical Section, Department of Neuroscience, Reproductive and Odontostomatological Sciences, Federico II University of Naples, 80138 Naples, Italy
10
Department of Clinical Sciences and Stomatology, Marche Polytechnic University, 60121 Ancona, Italy
11
Department of Biomedical and Neuromotor Sciences, Functional MR Unit, IRCCS Istituto delle Scienze Neurologiche di Bologna, University of Bologna, 40139 Bologna, Italy
*
Author to whom correspondence should be addressed.
†
Presented at the XV National and III International Congress of the Italian Society of Oral Pathology and Medicine (SIPMO), 17–19 October 2019, Bari, Italy.
Proceedings 2019, 35(1), 27; https://doi.org/10.3390/proceedings2019035027
Published: 11 December 2019
(This article belongs to the Proceedings of The XV National and III International Congress of the Italian Society of Oral Pathology and Medicine)
1. Introduction
In a recent study our research group described a non-invasive sampling procedure based on DNA methylation analysis of a set of 13 genes with a high level of accuracy (sensitivity 96.6%, specificity 100%) in the detection of squamous cell carcinoma of the oral cavity (OSCC) [1].
The purpose of the present study was to test the diagnostic performance of this non invasive sampling procedure in an italian multicentric study.
2. Materials and Methods
Oral brushing specimens were collected in ten different italian units of oral medicine. Each oral medicine unit collected blindly 10 brushing specimens from patients affected by OSCC and an equal number of age and sex-matched healthy controls. 13-gene DNA methylation analysis was performed and each sample was considered positive or negative in relation to a predefined cut-off value.
3. Results
181 out of 200 planned specimens were analyzed. DNA could not be amplified in 4 cases (2.2%). 86/93 (92.5%) specimens derived from OSCC patients were detected as positive and 70/84 (83.3%) specimens derived from healthy donors showed a negative score.
4. Conclusions
Data from multicentric study confirmed a high level of sensitivity of our procedure whereas level of specificity is slightly lower if compared to our previous study. These data suggest that our procedure may be proposed as a first level diagnostic test with the aim to avoid a diagnostic delay in Oral Squamous Cell Carcinoma.
Conflicts of Interest
As a possible conflict of interest, L. Morandi and D.B.G. submitted a patent (the applicant is the University of Bologna) in November 2016 to the National Institute of 398 Industrial Property; however, we believe that this is a natural step of translational research (bench-to-bedside) 399 and guarantee that the scientific results are true. The remaining authors declare that they have no competing 400 interest.
Reference
- Morandi, L.; Gissi, D.; Tarsitano, A.; Asioli, S.; Gabusi, A.; Marchetti, C.; Montebugnoli, L.; Foschini, M.P. CpG location and methylation level are crucial factors for the early detection of oral squamous cell carcinoma in brushing samples using bisulfite sequencing of a 13-gene panel. Clin. Epigenet. 2017, 9, 85. [Google Scholar] [CrossRef] [PubMed]
© 2019 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
Share and Cite
MDPI and ACS Style
Gissi, D.B.; Romeo, U.; Tenore, G.; Pentenero, M.; Campisi, G.; Mauceri, R.; Colella, G.; Luca, R.D.; Serpico, R.; Stasio, D.D.; et al. Clinical Validation of 13-gene DNA Methylation Analysis from Oral Brushing: A Non Invasive Sampling Procedure for Early Detection of Oral Squamous Cell Carcinoma. A Multicentric Study. Proceedings 2019, 35, 27. https://doi.org/10.3390/proceedings2019035027
AMA Style
Gissi DB, Romeo U, Tenore G, Pentenero M, Campisi G, Mauceri R, Colella G, Luca RD, Serpico R, Stasio DD, et al. Clinical Validation of 13-gene DNA Methylation Analysis from Oral Brushing: A Non Invasive Sampling Procedure for Early Detection of Oral Squamous Cell Carcinoma. A Multicentric Study. Proceedings. 2019; 35(1):27. https://doi.org/10.3390/proceedings2019035027
Chicago/Turabian StyleGissi, Davide B., Umberto Romeo, Gianluca Tenore, Monica Pentenero, Giuseppina Campisi, Rodolfo Mauceri, Giuseppe Colella, Roberto De Luca, Rosario Serpico, Dario Di Stasio, and et al. 2019. "Clinical Validation of 13-gene DNA Methylation Analysis from Oral Brushing: A Non Invasive Sampling Procedure for Early Detection of Oral Squamous Cell Carcinoma. A Multicentric Study" Proceedings 35, no. 1: 27. https://doi.org/10.3390/proceedings2019035027
