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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-08

Study Completion Date

2026-11-30

Brief Summary

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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.

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Detailed Description

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

Conditions

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Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Multi-omic approach to cancer diagnosis.

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No