Biobanking and New Biomolecular Metrics

NCT ID: NCT05906277

Last Updated: 2023-06-15

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

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-29

Study Completion Date

2025-12-31

Brief Summary

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The goal of this Interventional study aims to apply, in our Institutes, a 4p oncological model i.e. predictive, personalized, of precision and participated (Regina Elena and San Gallicano).

Detailed Description

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Patients will be recruited with an innovative and systematic scheme: collection and biobanking of biological materials (tissue biopsy, re-biopsy and liquid biopsy) followed by a molecular monitoring thanks to genomic and epigenomic methods. It's an open-ended study. In particular we will try to identify new "actionable" signatures and we will try to insert the patients to innovative clinical trials, thanks to the evaluation of all cases with a Molecular Tumor Board.

The main objectives are:

* Introduce a new methodology to improve and integrate the already existent institutional PDTA
* Evaluate and measure the applicative value
* Establish a biostatistical platform

Conditions

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Melanoma (Skin) Liquid Biopsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

The recruiting of two simultaneous cohorts is scheduled. a) patients of illness onset (Cohort 1); b) patients with locoregional disease and/or metastatic designed for systemic therapies (cohort 2).
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Biopsy

Liquid biopsy, re-biopsy, tissue biopsy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Melanoma affected patients

Exclusion Criteria

* No patiens affected by other pathology
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituti Fisioterapici Ospitalieri

OTHER

Sponsor Role collaborator

Regina Elena Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRE

Roma, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Patrizio Giacomini, MD

Role: CONTACT

+39 0652665054

Emilia Migliano, MD

Role: CONTACT

+390652666010

Facility Contacts

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Patrizio Giacomini, MD

Role: primary

06 52665051

Other Identifiers

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RS1174/19

Identifier Type: -

Identifier Source: org_study_id

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