Status:
RECRUITING
Multi-omic Approach to Cancer Diagnosis: the Italian Network of Excellence for Advanced Diagnosis (INNOVA)
Lead Sponsor:
National Cancer Institute, Naples
Conditions:
Neoplasms
Eligibility:
All Genders
18-100 years
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 Pascal...
Detailed Description
The study is multicentric, observational, non-interventional, and both prospective and retrospective.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 8 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT06884878
Start Date
October 8 2024
End Date
November 1 2026
Last Update
March 24 2025
Active Locations (1)
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1
Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale
Napoli, Italy, 80131