Prototyping of Molecular Testing and Clinical-Analytical Validation of Cervical Micrometastases Diagnosis in Head and Neck Cancer

• Grant number: 24/17117-2
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: July 01, 2025
• End date: June 30, 2027
• Field of knowledge: Physical Sciences and Mathematics - Chemistry - Analytical Chemistry
• Principal Investigator: Thiago Martimiano do Prado
• Grantee: Thiago Martimiano do Prado
• Company: Clyons Pesquisa e Desenvolvimento em Biotecnologia Inova Simples (IS)
• CNAE: Pesquisa e desenvolvimento experimental em ciências físicas e naturais
• City: São Carlos
• Associated researchers: Camila Corona de Godoy Bueno ; Daniele Moraes Losada ; Lidia Maria Rebolho Batista Arantes ; Ricardo Ribeiro Gama ; Ronaldo Censi Faria ; Wilson Eduardo Furlan Matos Alves
• Associated research grant: 22/12827-6 - Development and evaluation of a test for the miRNA-203 biomarker detection in liquid biopsy sample for the diagnosis of head and neck cancer, AP.PIPE
• Associated scholarship(s): 25/11133-9 - Analytical validation and clinical research of a molecular assay Used in the diagnosis of micrometastases in head and neck cancer, BP.TT; 25/11070-7 - Prototyping and clinical-analytical validation of a molecular test for diagnosing cervical micrometastases in head and neck cancer, BP.PIPE

Abstract

The mortality rate due to head and neck cancer is a significant public health issue, with oral cancer cases standing out. Cervical lymph node micrometastases are one of the main prognostic factors for this disease. In clinically N0 cases of oral cancer in the lower floor and neck, current clinical protocols adopt sentinel lymph node resection or selective cervical dissection based on the clinical staging of the primary tumor. However, cytopathological exams do not always show sensitive results for the presence of micrometastases, leading to two possible scenarios: about 70 to 80% of patients undergo unnecessary surgical staging of the neck, or about 20 to 30% of cases, where surgical staging with sentinel lymph node or elective lymphadenectomy is not performed, result in the progression of micrometastases and detection of advanced-stage clinical cervical metastasis. In this context, the proposal of a molecular test to identify micrometastases in sentinel lymph nodes, through fine needle aspiration cytology, presents an innovative solution for diagnosing patients affected by this disease. This project outlines activities for the continuation of a completed PIPE Phase 1 project, where the proof of concept for the functionality of the proposed molecular test was successfully achieved. The test is based on the clinical validation of the system developed in PIPE Phase 1, focusing on the identification of miRNA-203 in cervical lymph node samples from patients with oral cavity tumors, collected via fine needle aspiration. Thus, the clinical validation phases of the test are intended to be carried out. These activities are crucial for validating the utility of the test and advancing the process, so that the reagent kit used in the diagnostic method and the sample processing equipment can be offered to hospitals and laboratories as a tool for diagnosing micrometastases. Furthermore, this project also proposes (i) the application of a minimum viable product (MVP) in the environment of the Hospital de Amor in Barretos, (ii) the construction of a prototype device for sample processing automation, and (iii) the identification of the biomarker in serum and plasma samples obtained from peripheral blood, with a medium/long-term perspective of possible application of the test for systemic disease prognosis (liquid biopsy). A cooperation agreement has been established with Fundação Pio XII (Hospital de Amor in Barretos) and Harena Inovação for the execution of the project. (AU)