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

NCT06884878 | Recruiting

• 1 other identifier: INNOVA
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Multi-omic approach to cancer diagnosis. OTHER

To assess the impact of intratumoral heterogeneity on the effectiveness of targeted therapies and immunotherapy.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Oncologic patients eligible for targeted therapy and/or immunotherapy.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (1)

Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale

Napoli, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Antonella De Luca

  IRCCS I.N.T. "G. Pascale"

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonella De Luca

CONTACT

08117770603; a.deluca@istitutotumori.na.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 19, 2025
• Study Start: October 8, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)