Biobanking and New Biomolecular Metrics (Melamoma4p)

Melanoma 4p: Biobanking and New Biomolecular Metrics

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).

Study Overview

• Status: Recruiting
• Conditions: Melanoma (Skin); Liquid Biopsy
• Intervention / Treatment: Diagnostic test: Biopsy

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

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrizio Giacomini, MD; Phone Number: +39 0652665054; Email: patrizio.giacomini@ifo.it
• Study Contact Backup: Name: Emilia Migliano, MD; Phone Number: +390652666010; Email: emilia.migliano@ifo.it

Study Locations

• Italy
  • Roma, Italy, 00144
    • Recruiting
    • IRE
    • Contact: Patrizio Giacomini, MD; Phone Number: 06 52665051; Email: patrizio.giacomini@ifo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Melanoma affected patients

Exclusion Criteria:

• No patiens affected by other pathology

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oncology target therapy	Integration between molecular diagnostic and melanoma histopathology: correlation between mutational miRNA/ncRNA profiles and pathological staging parameters.	12 months
Oncology target therapy	Correlation between molecular diagnostic and imaging non-invasive instrumental diagnostic	12 months
Oncology target therapy	Correlation between molecular diagnostic and dermatologic clinical diagnostic; integration of liquid biopsy during oncologic ambulatorial follow-up; lead time of relapse.	12 months
Oncology target therapy	Complement to surgery	12 months

Collaborators and Investigators

• Sponsor: Regina Elena Cancer Institute
• Collaborators: Istituti Fisioterapici Ospitalieri

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2019
• Primary Completion (Actual): December 1, 2022
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 24, 2023
• First Submitted That Met QC Criteria: June 7, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: RS1174/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No