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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Naples, 80131, Italy

Location status: Recruiting

Location contact

Antonella De Luca

CONTACT

[email protected]

08117770603

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-omic approach to cancer diagnosis.

Other

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

Primary outcomes

Disease progression

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Antonella De Luca

CONTACT

[email protected]

08117770603

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Naples

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Mar 19, 2025
Registry last updated: Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting