Biobanking and New Biomolecular Metrics

Not Applicable

Recruiting

• Conditions: Liquid Biopsy; Melanoma (Skin)

• Registration Number: NCT05906277
• Lead Sponsor: Regina Elena Cancer Institute

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

Study Timeline

• Study Start: 2019-01-29
• Primary Completion: 2022-12-01
• Status Verified: 2023-03
• Study First Submitted: 2023-03-24
• Study First Submitted QC: 2023-06-07
• Last Update Submitted: 2023-06-07
• Study First Posted: 2023-06-15
• Last Update Posted: 2023-06-15
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Melanoma affected patients

Exclusion Criteria

• No patiens affected by other pathology

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Oncology target therapy	12 months	Complement to surgery

Trial Locations

Locations (1)

IRE; 🇮🇹 Roma, Italy