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Melamoma4p: Biobanking and New Biomolecular Metrics

Sponsor
Regina Elena Cancer Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05906277
Collaborator
Istituti Fisioterapici Ospitalieri (Other)
300
Enrollment
1
Location
83.1
Anticipated Duration (Months)
3.6
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Biopsy
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
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).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)
Primary Purpose:
Diagnostic
Official Title:
Melanoma 4p: Biobanking and New Biomolecular Metrics
Actual Study Start Date :
Jan 29, 2019
Actual Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 31, 2025

Outcome Measures

Primary Outcome Measures

  1. Oncology target therapy [12 months]

    Integration between molecular diagnostic and melanoma histopathology: correlation between mutational miRNA/ncRNA profiles and pathological staging parameters.

  2. Oncology target therapy [12 months]

    Correlation between molecular diagnostic and imaging non-invasive instrumental diagnostic

  3. Oncology target therapy [12 months]

    Correlation between molecular diagnostic and dermatologic clinical diagnostic; integration of liquid biopsy during oncologic ambulatorial follow-up; lead time of relapse.

  4. Oncology target therapy [12 months]

    Complement to surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Melanoma affected patients
Exclusion Criteria:
  • No patiens affected by other pathology

Contacts and Locations

Locations

Site City State Country Postal Code
1 IRE Roma Italy 00144

Sponsors and Collaborators

  • Regina Elena Cancer Institute
  • Istituti Fisioterapici Ospitalieri

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Regina Elena Cancer Institute
ClinicalTrials.gov Identifier:
NCT05906277
Other Study ID Numbers:
  • RS1174/19
First Posted:
Jun 15, 2023
Last Update Posted:
Jun 15, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Melanoma

Study Results

No Results Posted as of Jun 15, 2023