DIAGNOSIS OF RECURRENCE & METASTASIS OF TRIPLE NEGATIVE BREAST CANCER
Triple negative breast cancer (TNBC) is one of the most heterogeneous breast cancers with a typically aggressive clinical course. It often has small size and negative lymph nodes. In the initial phase, TNBC is characterised by local and systemic relapses with 20-40% of patients developing metastases. There are currently no predictive markers in clinical practice.The purpose of the invention is to provide a diagnostic method capable of classifying TNBC patients at high risk of relapse and / or metastasis without the need for an invasive biopsy. At the basis of the study of a prognostic factor in TNBC, the ID4 protein. In breast cancer, an elevated level of ID4 protein is specific to the TNBC subtype, where the ID4 gene can be amplified and / or over-expressed and where it distinguishes a subset of TNBCs with poor prognosis.
The high expression of ID4 increases the angiogenic potential both through the stabilization and induction of pro-angiogenic factors in tumor cells, and through the reprogramming of tumor-associated macrophages in a pro-angiogenic sense. ID4, in collaboration with other factors (the mutated p53 protein, the splicing factor SRSF1 and the lncRNA MALAT1) is also able to induce the expression of circular RNA, which are also secreted by cells in extracellular lipid vesicles (exosomes). The detection of these circular RNAs in liquid biopsy samples (blood, serum, plasma) is aimed at identifying patients at high risk of recurrence/metastasis. The kit includes reagents to measure the following circRNAs: circVEGF, circFGFR3, circSKIV2L, circPDGFRB, circLTBP2. Detection takes place with RT-qPCR assays. Objective: to define prognosis and treatment. The current TRL of technology is TRL3 (xperimental proof of concept), the one we hope to achieve at the end of the R&D activities is TRL 6 (technology demonstrated in relevant environment – industrially relevant environment in the case of key enagling technologies-).
- Detect circRNA expression from liquid biopsy samples for TNBC tumor diagnosis.
- It measures recurrence / metastasis in patients with TNBC;
- It uses robust non-invasive biomarkers such as circRNAs;
- Optimize treatment costs;
- RNA measured with RT-qPCR assays (sensitive and quantitative method);
- Replacement of the traditional invasive diagnosis (tissue biopsy) with a less invasive method.