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Biobanking and New Biomolecular Metrics

Melanoma 4p: Biobanking and New Biomolecular Metrics

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05906277
Acronym
Melamoma4p
Enrollment
300
Registered
2023-06-15
Start date
2019-01-29
Completion date
2025-12-31
Last updated
2023-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liquid Biopsy, Melanoma (Skin)

Brief summary

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

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

Interventions

DIAGNOSTIC_TESTBiopsy

Liquid biopsy, re-biopsy, tissue biopsy

Sponsors

Istituti Fisioterapici Ospitalieri
CollaboratorOTHER
Regina Elena Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

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).

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Melanoma affected patients

Exclusion criteria

* No patiens affected by other pathology

Design outcomes

Primary

MeasureTime frameDescription
Oncology target therapy12 monthsIntegration between molecular diagnostic and melanoma histopathology: correlation between mutational miRNA/ncRNA profiles and pathological staging parameters.

Countries

Italy

Contacts

Primary ContactPatrizio Giacomini, MD
patrizio.giacomini@ifo.it+39 0652665054
Backup ContactEmilia Migliano, MD
emilia.migliano@ifo.it+390652666010

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026