Biobanking and New Biomolecular Metrics

Melanoma (Skin) Clinical Trial

— Melamoma4p  

Official title:

Melanoma 4p: Biobanking and New Biomolecular Metrics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05906277
• Other study ID #: RS1174/19
• Status: Recruiting
• Phase: N/A
• Start date: January 29, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2023
• Source: Regina Elena Cancer Institute
• Contact: Patrizio Giacomini, MD
• Phone: +39 0652665054
• Email: patrizio.giacomini[@]ifo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2025
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Melanoma affected patients

Exclusion Criteria:

• No patiens affected by other pathology

Related Conditions & MeSH terms

• Liquid Biopsy
• Melanoma
• Melanoma (Skin)

Intervention

Diagnostic Test:
• Biopsy
Liquid biopsy, re-biopsy, tissue biopsy

Locations

Country	Name	City	State
Italy	IRE	Roma

Sponsors (2)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute	Istituti Fisioterapici Ospitalieri

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oncology target therapy	Integration between molecular diagnostic and melanoma histopathology: correlation between mutational miRNA/ncRNA profiles and pathological staging parameters.	12 months
Primary	Oncology target therapy	Correlation between molecular diagnostic and imaging non-invasive instrumental diagnostic	12 months
Primary	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
Primary	Oncology target therapy	Complement to surgery	12 months