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 volunteersQualifiers
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
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Primary objective - Hybrid taxonomy
Integrate histopathology and molecular analyses to provide a novel hybrid taxonomy of melanoma in CAYA.
Primay objective - Histopathological and molecular features of pediatric melanoma
Assess the histopathological and molecular features of pediatric melanomas.
Secondary outcomes
Secondary Objective - Identification of biomarkers
Identify prognostic biomarkers in the context of immunotherapy and targeted therapy.
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.
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.
Sponsors and contacts
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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