Introduction

The invention relates to an in vitro method for early detection of head and neck squamous carcinoma (OSCC). The diagnosis is based on the quantitative evaluation of the methylation status of a panel consisting of 13 genes, starting from a sample taken with a small brush. The method also allows to predict any relapses and a bad prognosis in areas adjacent to those already surgically treated.

Technical features

Oral cancers are nowadays diagnosed on the basis of  biopsy implying an invasive surgical approach. Non-invasive methods to detect malignant oral lesions, including those at an early stage, are of the sure interest to increase patient adherence and, consequently, reduce mortality from this type of cancer. The invention consists of a method for the early identification of patients at high risk of developing an OSCC or its precursors such as, for example, high-grade dysplasias, through the quantitative assessment of the DNA methylation level using the Bisulfite Next Generation Sequencing. The test includes the oral mucosa cells collection with a small brush, and the laboratory analysis of 13 markers whose altered level of methylation is linked with the onset of OSCC.

Possible Applications

• Early diagnosis of OSCC;
• Prediction of prognosis in patients operated for an OSCC.

Advantages

• High specificity and high sensitivity of diagnosis;
• Non-invasiveness;
• Greater patient adherence;
• Reduction of mortality from OSCC;
• Impartiality of the test.