Introduction

Local recurrence causes death in HNSCC (Head and neck squamous cell carcinoma ) patients. Prognosis and therapy depend on the TNM stage. This, based on histological examination, is limited in predicting the prognosis, not reflecting the molecular heterogeneity of the tumor. Patients with the same TNM have different clinical responses. The high mortality rate is linked to limits such as: investigation methods (histology and imaging) and by the invasiveness of the histological sampling.

Technical features

The invention provides a method for the in vitro diagnosis of HNSCC tumor recurrence and/or persistence in patients undergoing head/neck tumor removal. The expression of 4 circulating miRNAs (miR-21-5p, miR-21-3p, miR-96-5p and miR-429) related to relapse is measured. We propose detection within serum and saliva in patients whose diagnosis is already histologically confirmed. For each patient, multiple blood and saliva samples are collected at different times: before surgery, the next day, 15 days after and during the follow-up visit. The expression of one, more than one or all of the mentioned miRNAs is measured in a liquid biopsy sample taken before tumor removal and in a sample taken after tumor removal. If the expression of miRNAs in at least one sample taken after tumor removal is >= compared to the expression in at least one sample taken before tumor removal, we are in the presence of a high risk of tumor recurrence/persistence; an expression < indicates low risk of recurrence/persistence.

Possible Applications

• This kit detects the expression of 4 miRNAs from liquid biopsy samples in diagnosis of HNSCC tumor;
• The kit measures the expression of one or more of the following miRNAs: miR-21-5p, miR-21-3p, miR-96-5p and miR-429;
• The detection is carried out with RT-qPCR assays. 

Advantages

• Non-invasive test that allows you to formulate a more realistic diagnosis/prognosis;
• Specific for HNSCC patients;
• The 4 microRNAs are prognostic both individually and together;
• It is developed taking into consideration the intratumoral heterogeneity;
• Specific and sensitive with taqman assay technology used.