Multi-omic Approach to Cancer Diagnosis: the Italian Network of Excellence for Advanced Diagnosis (INNOVA)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multi-omic approach to cancer diagnosis..
- Who it may be relevant to
- Registry conditions: Neoplasms. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Multi-omic approach to cancer diagnosis.
To assess the impact of intratumoral heterogeneity on the effectiveness of targeted therapies and immunotherapy.
Primary outcome measures
- Disease progression [Time frame: approximately 3 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale — Naples
Identifiers
NCT: NCT06884878 · INNOVA