MELCAYA - Novel Health Care Strategies for Melanoma in Children, Adolescents, and Young Adults - Work Package 3 (WP3)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 30
SponsorUniversity of Florence

About this trial

The aim of this study is to investigate a type of skin cancer, also known as melanoma, in children, adolescents, and young adults, who will be referred to as CAYA patients in this project. The need for this study arises because this disease, in CAYA patients, is still poorly understood due to its rarity in individuals under 30 years old. This often leads to difficulties in assessing its severity and, consequently, in deciding on the necessary treatments to ensure the patient\'s recovery. The goal of this study is to examine melanoma in CAYA patients in order to gather the information needed to provide better diagnoses for affected patients and, as a result, select appropriate treatments to fight the disease and promote the patient\'s full recovery. Additionally, the data collected will be used to create a Pan-European online platform that will allow doctors across the European Union to consult the obtained data and collaborate on particularly complex melanoma cases, always with the aim of ensuring the patient\'s full recovery in the shortest possible time.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

adolescent and childhood patients (< 20 years) or young adults (< 30 years)

histologically confirmed diagnosis of melanoma or intermediate/ambiguous melanocytic neoplasm (i.e., melanocytomas, SAMPUS, IAMPUS and MELTUMP according to WHO classification)

Disqualifiers

adult patients (> 30 years of age)

patients without histologically confirmed diagnosis of melanoma or intermediate/ambiguous melanocytic neoplasm

Trial population

The study will focus on CAYA (\< 30 y.o) patients with histologically confirmed melanoma or intermediate/ambiguous melanocytic neoplasm (i.e.,melanocytomas, SAMPUS, IAMPUS and MELTUMP according to WHO classification).The population include patients of both genders.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 1 trial group
Group A: CAYA Melanoma patients

Trial outcomes

Primary outcomes

1

Primary objective - Hybrid taxonomy

Integrate histopathology and molecular analyses to provide a novel hybrid taxonomy of melanoma in CAYA.

Time frame
From enrollment at the end of 32 months
2

Primay objective - Histopathological and molecular features of pediatric melanoma

Assess the histopathological and molecular features of pediatric melanomas.

Time frame
From enrollment at the end of 32 months

Secondary outcomes

1

Secondary Objective - Identification of biomarkers

Identify prognostic biomarkers in the context of immunotherapy and targeted therapy.

Time frame
From enrollment at the end of 32 months
2

Secondary Objective - pan-European digital pathology platform

Create a pan-European digital pathology platform to assess diagnostic inter-observer reproducibility, enhance international collaboration and achieve diagnosis standardization.

Time frame
From enrollment at the end of 32 months
3

Secondary Objective - Identification of prognostic and predictive biomarkers

Identify driver mutations, transcriptomes, and DNA methylation subclasses with morphological, immunophenotypic analyses and clinical data to provide a novel hybrid taxonomy and identify tissue prognostic and predictive biomarkers.

Time frame
From enrollment at the end of 32 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florence

Lead sponsor

Tubingen University Hospital

Collaborator

Maria Sklodowska-Curie National Research Institute of Oncology

Collaborator

Fondazione IRCCS ISTITUTO NAZIONALE TUMORI

Collaborator

Hospital Clinic of Barcelona

Collaborator

Istanbul University

Collaborator

University Of Perugia

Collaborator

German Cancer Research Center

Collaborator