Neoplasms
Conditions
Brief summary
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.
Detailed description
The study is multicentric, observational, non-interventional, and both prospective and retrospective.
Interventions
OTHERMulti-omic approach to cancer diagnosis.
To assess the impact of intratumoral heterogeneity on the effectiveness of targeted therapies and immunotherapy.
Sponsors
National Cancer Institute, Naples
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease progression | approximately 3 years | Rate of metastatic patients with disease progression (PD) within 3 months from the start of targeted therapy and/or immunotherapy, or disease recurrence rate at 6 months in patients undergoing adjuvant therapy. |
Countries
Italy
Contacts
Primary ContactAntonella De Luca
Outcome results
None listed