NCT05906277

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 15, 2023

Status Verified

March 1, 2023

Enrollment Period

3.8 years

First QC Date

March 24, 2023

Last Update Submit

June 7, 2023

Conditions

Melanoma (Skin)Liquid Biopsy

Outcome Measures

Primary Outcomes (4)

  • Oncology target therapy

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

    12 months

  • Oncology target therapy

    Correlation between molecular diagnostic and imaging non-invasive instrumental diagnostic

    12 months

  • 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

  • Oncology target therapy

    Complement to surgery

    12 months

Interventions

BiopsyDIAGNOSTIC_TEST

Liquid biopsy, re-biopsy, tissue biopsy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Melanoma affected patients

You may not qualify if:

  • No patiens affected by other pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRE

Roma, 00144, Italy

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Patrizio Giacomini, MD

CONTACT

+39 0652665054patrizio.giacomini@ifo.it

Emilia Migliano, MD

CONTACT

+390652666010emilia.migliano@ifo.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2023

First Posted

June 15, 2023

Study Start

January 29, 2019

Primary Completion

December 1, 2022

Study Completion

December 31, 2025

Last Updated

June 15, 2023

Record last verified: 2023-03

Locations

IT(1)