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Trial Title:
Biobanking and New Biomolecular Metrics
NCT ID:
NCT05906277
Condition:
Melanoma (Skin)
Liquid Biopsy
Conditions: Official terms:
Melanoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
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).
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Biopsy
Description:
Liquid biopsy, re-biopsy, tissue biopsy
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Melanoma affected patients
Exclusion Criteria:
- No patiens affected by other pathology
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
IRE
Address:
City:
Roma
Zip:
00144
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Patrizio Giacomini, MD
Phone:
06 52665051
Email:
patrizio.giacomini@ifo.it
Start date:
January 29, 2019
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Regina Elena Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Istituti Fisioterapici Ospitalieri
Agency class:
Other
Source:
Regina Elena Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05906277
