Introduction

Mucositis affects the oral cavity/oropharynx. Erythema, edema and ulcer characterize it. It generates pain, debilitates and affects the quality of life of a patient. 40% of chemotherapy patients and almost all of those affected by HNC (Head and Neck) tumors develop it: 16% are hospitalized to manage it, amongst these 11% stop treatments. The invention proposes a diagnosis on the levels of 6 microRNAs in biological fluids. Currently, there are no specific therapies for the treatment of mucositis; the current ones are only as support to alleviate the symptoms. There are recommendations to prevent it whose effectiveness, however, is reduced. Diagnosis today is made following the guidelines for measuring the degree of mucositis.

Technical features

As a solution, a simple and non-invasive molecular test is now proposed which allows the early identification of the process, making patient management rapid based on the clinical picture/anamnestic. Pathogenesis is characterized by 5 stages: initiation of tissue damage, signal transmission, signal amplification, ulceration/inflammation and repair. According to the invention it was found that six microRNAs, hsa-miR-18b-3p, hsa-miR-494-3p, hsa-miR-1202, hsa-miR-3135b, hsa-miR-6769b-5p and/or hsa -miR-6875-5p, are related to the development of mucositis following anti-tumor treatments (chemotherapy and/or radiotherapy). The modulation of the levels of these miRNAs can be found at the initial stage of the pathogenesis, i.e. the initiation of tissue damage, making these miRNAs suitable for rapidly diagnosing mucositis. The test allows to detect changes in the expression levels of 6 microRNAs in the initial phase of the process. At the moment the TRL of the technology is 3, the R&D activities being currently undertaken aim to raise its level to 6.

Possible Applications

• Kit for in vitro diagnosis of mucositis in patients undergoing anti-tumor therapy;
• It includes one or more primer pairs to detect by Real Time PCR or Microarray one, more than one or all miRNAs: hsa-miR-18b-3p, hsa-miR-494-3p, hsa-miR-1202, hsa-miR -3135b, hsa-miR-6769b-5p and / or hsa-miR-6875-5.

Advantages

• Early diagnosis;
• The rapid detection of miRNA expression facilitates the rapid management of the disease by reducing hospitalizations and the increase in costs for the SSN;
• Simple and non-invasive method;
• Small quantity of biological sample (saliva and/or serum);
• Reliable, sensitive and specific technology;