OMNI-BCG
Urinary omic profiling and integrated nutraceuticals: a non-pharmacological interventional pilot study supporting BCG therapy in non-muscle-invasive bladder cancer – OMNI-BCG.
The project involves the development of a multi-omic urinary test predictive of the response to BCG therapy in non-muscle-invasive bladder cancer.
The project
OMNI-BCG is an industrial research and experimental development project aimed at creating an integrated personalised-medicine approach for the treatment of non-muscle-invasive bladder cancer (NMIBC) undergoing intravesical therapy with Bacillus Calmette-Guérin (BCG).
The project combines advanced multi-omic methodologies, bioinformatics and clinical nutraceuticals with the aim of improving patient stratification, treatment tolerability and clinical outcomes.
The initiative involves the prospective collection of urinary samples and clinical data from high-risk NMIBC patients, subsequently analysed using metabolomics, proteomics, miRNomics and metagenomics platforms.
The integration of biological data through machine-learning algorithms will enable the identification of predictive biomarkers associated with therapeutic response, toxicity and recurrence risk, supporting the development of a non-invasive urinary test for precision medicine in the uro-oncology field.
In parallel, the project develops URO-DUO, an innovative nutraceutical supplement formulated with natural bioactive compounds selected for their potential protective effect on the bladder mucosa and the inflammatory microenvironment.
The multidisciplinary approach adopted by the consortium — composed of the University of Naples Federico II, MeriGen and La.Fa.Re.
Farmaceutica — aims to foster the technology transfer of the results towards high-impact clinical and industrial applications in the field of advanced diagnostics and Nutraceuticals for oncology applications.
Results
The OMNI-BCG project aims to develop an innovative personalised-medicine model for the treatment of non-muscle-invasive bladder cancer through the integration of multi-omic technologies, advanced bioinformatics and clinical nutraceuticals.
The main objective is to identify predictive urinary biomarkers associated with treatment response, toxicity and recurrence risk in patients undergoing intravesical BCG immunotherapy.
Through metabolomics, proteomics, miRNomics and metagenomics analyses, the project aims to create a non-invasive urinary diagnostic test based on machine-learning algorithms, capable of supporting the clinician in patient stratification and in the optimisation of therapeutic pathways.
In parallel, OMNI-BCG intends to develop URO-DUO, a nutraceutical supplement formulated with natural bioactive compounds selected to improve urinary function, reduce the side effects associated with BCG treatment and help maintain the cancer patient's quality of life.
The OMNI-BCG project envisages the achievement of results of high scientific, clinical and industrial value in the field of uro-oncology and personalised medicine.
Among the main expected results is the development of a non-invasive multi-omic urinary diagnostic test, based on the integration of metabolic, protein and miRNA biomarkers and microbiota profiles associated with the response to BCG therapy.
The diagnostic system will be supported by machine-learning algorithms for predictive patient stratification and the optimisation of therapeutic pathways.
A further expected result concerns the formulation and preliminary validation of URO-DUO, an innovative nutraceutical supplement designed to improve the tolerability of intravesical therapy, support urinary function and contribute to maintaining the cancer patient's quality of life.
The project will also produce integrated multi-omic datasets, advanced bioinformatic models and new scientific evidence on the biological mechanisms involved in the immune response to BCG.
