Advanced cancer diagnosis using multi-omic profiling
Multi-omic Approach to Cancer Diagnosis: the Italian Network of Excellence for Advanced Diagnosis (INNOVA)
National Cancer Institute, Naples · NCT06884878
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 |
|---|---|
| Enrollment | 103 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | National Cancer Institute, Naples (other) |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Naples) |
| Trial ID | NCT06884878 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with aggressive neoplasms who are eligible for targeted therapy or immunotherapy.
Not a fit: Patients who have previously undergone immunotherapy or targeted therapy may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Naples
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neoplasms