Advanced cancer diagnosis using multi-omic profiling
Official title: Multi-omic Approach to Cancer Diagnosis: the Italian Network of Excellence for Advanced Diagnosis (INNOVA)
Run by National Cancer Institute, Naples · NCT06884878 · Data updated 2026-11-12
This study is testing a new way to improve cancer diagnosis by using a mix of biological samples and medical images to help doctors choose the best treatments for patients in Italy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 103 (estimated) |
| Sponsor | National Cancer Institute, Naples Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Naples) |
| Status | Recruiting |
| Started | October 8, 2024 |
| Main results expected | November 2026 |
| Study ends | November 2026 |
| Registry record updated | March 24, 2025 |
| Trial ID | NCT06884878 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 with aggressive neoplasms who are eligible for targeted therapy or immunotherapy.
✕Probably not a fit
Patients who have previously undergone immunotherapy or targeted therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The INNOVA project aims to develop a multidisciplinary diagnostic platform to enhance cancer diagnosis within the Italian healthcare system. This observational study focuses on creating a national platform for multi-omic profiling of cancer patients who are eligible for precision medicine treatments. It involves both prospective and retrospective data collection, utilizing biological samples and radiological images to support clinical decision-making for targeted therapies. The study is coordinated by the Pascale Institute and involves multiple centers across Italy.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate cancer diagnoses and improved treatment strategies for patients.
How similar studies have gone: Other studies utilizing multi-omic approaches have shown promise in improving cancer diagnosis and treatment outcomes, indicating a potential for success in this novel approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale
Naples, Italy Recruiting
Study contacts
- Principal investigator: Antonella De Luca — IRCCS I.N.T. "G. Pascale"
- Study coordinator: Antonella De Luca
- Email: a.deluca@istitutotumori.na.it
- Phone: 08117770603
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.