The INNOVA project aims to create an advanced multidisciplinary diagnostic platform to support the Italian healthcare system and translational research. In this context, WP7, coordinated by the Pascale Institute and the focus of this study protocol, is responsible for developing a national platform for the multi-omic profiling of cancer patients eligible for precision medicine treatments, with the goal of supporting clinical decision-making.

The study is multicentric, observational, non-interventional, and both prospective and retrospective.

Inclusion Criteria:

• Consent to participate in the study
• Age >18 years
• Performance status (PS) 0-1
• Availability of biological samples for multi-omic profiling
• Availability of radiological images for radiomic assessments
• Patients with metastatic disease, i.e., stage IV (except for melanoma, where stage II/III patients eligible for adjuvant therapy may also be considered)
• Patients eligible for targeted therapy and/or immunotherapy
• Patients with aggressive neoplasms, including melanoma, non-small cell lung carcinoma (NSCLC), colon carcinoma (BRAF-mutated, MSI), triple-negative breast cancer, ovarian cancer, and cholangiocarcinoma.

Exclusion Criteria:

• Previous line of immunotherapy or targeted therapy
• Previous radiotherapy at the sites of the most recent diagnostic biopsy
• Most recent diagnostic biopsy performed >24 months before enrollment
• Absence of measurable lesions
• Presence of active or untreated brain metastases or leptomeningeal carcinomatosis

Oncologic patients eligible for targeted therapy and/or immunotherapy.