Multi-omic Approach to Cancer Diagnosis: the Italian Network of Excellence for Advanced Diagnosis (INNOVA)

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.

Study Overview

• Status: Recruiting
• Conditions: Neoplasms
• Intervention / Treatment: Other: Multi-omic approach to cancer diagnosis.

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 103

Contacts and Locations

• Study Contact: Name: Antonella De Luca; Phone Number: 08117770603; Email: a.deluca@istitutotumori.na.it

Study Locations

• Italy
  • Napoli, Italy, 80131
    • Recruiting
    • Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale
    • Contact: Antonella De Luca; Phone Number: 08117770603; Email: a.deluca@istitutotumori.na.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Oncologic patients eligible for targeted therapy and/or immunotherapy.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease progression	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.	approximately 3 years

Collaborators and Investigators

• Sponsor: National Cancer Institute, Naples
• Investigators: Principal Investigator: Antonella De Luca, IRCCS I.N.T. "G. Pascale"

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: March 13, 2025
• First Submitted That Met QC Criteria: March 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: INNOVA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No