NeoplasmsNCT06884878
Multi-omic Approach to Cancer Diagnosis: the Italian Network of Excellence for Advanced Diagnosis (INNOVA)
An observational study of Neoplasms, run by National Cancer Institute, Naples at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Neoplasms
- What is being tested?
- Multi-omic approach to cancer diagnosis.
- How many people
- 103 participants
- Where
- 1 siteItaly
- Study dates
- 8 Oct 2024to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Oncologic patients eligible for targeted therapy and/or immunotherapy.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale
Naples, 80131
Antonella De Luca, 08117770603, a.deluca@istitutotumori.na.it
About this study
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.
Read the detailed description
The study is multicentric, observational, non-interventional, and both prospective and retrospective.
- Conditions
- Neoplasms
- Being tested
- Multi-omic approach to cancer diagnosis.
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-omic approach to cancer diagnosis.Other
To assess the impact of intratumoral heterogeneity on the effectiveness of targeted therapies and immunotherapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start8 Oct 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonella De Luca, Principal investigator, IRCCS I.N.T. "G. Pascale"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884878
- Sponsor's protocol ID
- INNOVA
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-omic Approach to Cancer Diagnosis: the Italian Network of Excellence for Advanced Diagnosis (INNOVA)
- ClinicalTrials.gov ID
- NCT06884878
- Acronym / sponsor ID
- INNOVA
- Conditions
- Neoplasms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is multicentric, observational, non-interventional, and both prospective and retrospective.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Oncologic patients eligible for targeted therapy and/or immunotherapy.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-omic approach to cancer diagnosis.To assess the impact of intratumoral heterogeneity on the effectiveness of targeted therapies and immunotherapy. | Other | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonella De Luca principal investigator
IRCCS I.N.T. "G. Pascale"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, run by National Cancer Institute, Naples at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonella De Luca (08117770603, a.deluca@istitutotumori.na.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease progression (time frame: approximately 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.