Biobanking and New Biomolecular Metrics (Melamoma4p)
Primary Purpose
Melanoma (Skin), Liquid Biopsy
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Melanoma (Skin)
Eligibility Criteria
Inclusion Criteria: Melanoma affected patients Exclusion Criteria: No patiens affected by other pathology
Sites / Locations
- IRERecruiting
Outcomes
Primary Outcome Measures
Oncology target therapy
Integration between molecular diagnostic and melanoma histopathology: correlation between mutational miRNA/ncRNA profiles and pathological staging parameters.
Oncology target therapy
Correlation between molecular diagnostic and imaging non-invasive instrumental diagnostic
Oncology target therapy
Correlation between molecular diagnostic and dermatologic clinical diagnostic; integration of liquid biopsy during oncologic ambulatorial follow-up; lead time of relapse.
Oncology target therapy
Complement to surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT05906277
First Posted
March 24, 2023
Last Updated
June 7, 2023
Sponsor
Regina Elena Cancer Institute
Collaborators
Istituti Fisioterapici Ospitalieri
1. Study Identification
Unique Protocol Identification Number
NCT05906277
Brief Title
Biobanking and New Biomolecular Metrics
Acronym
Melamoma4p
Official Title
Melanoma 4p: Biobanking and New Biomolecular Metrics
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 29, 2019 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regina Elena Cancer Institute
Collaborators
Istituti Fisioterapici Ospitalieri
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin), Liquid Biopsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
Biopsy
Intervention Description
Liquid biopsy, re-biopsy, tissue biopsy
Primary Outcome Measure Information:
Title
Oncology target therapy
Description
Integration between molecular diagnostic and melanoma histopathology: correlation between mutational miRNA/ncRNA profiles and pathological staging parameters.
Time Frame
12 months
Title
Oncology target therapy
Description
Correlation between molecular diagnostic and imaging non-invasive instrumental diagnostic
Time Frame
12 months
Title
Oncology target therapy
Description
Correlation between molecular diagnostic and dermatologic clinical diagnostic; integration of liquid biopsy during oncologic ambulatorial follow-up; lead time of relapse.
Time Frame
12 months
Title
Oncology target therapy
Description
Complement to surgery
Time Frame
12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Melanoma affected patients
Exclusion Criteria:
No patiens affected by other pathology
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrizio Giacomini, MD
Phone
+39 0652665054
Email
patrizio.giacomini@ifo.it
First Name & Middle Initial & Last Name or Official Title & Degree
Emilia Migliano, MD
Phone
+390652666010
Email
emilia.migliano@ifo.it
Facility Information:
Facility Name
IRE
City
Roma
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrizio Giacomini, MD
Phone
06 52665051
Email
patrizio.giacomini@ifo.it
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Biobanking and New Biomolecular Metrics
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