Identification of Risk Factors, Exposomics and Genetic Susceptibility of Melanoma in Children, Adolescents and Young Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Melanoma, Spitzoid Melanoma, Congenital Nevi. Basic parameters: up to 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany, Italy, Poland, Spain, Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Identification of Risk Factors, Exposomics and Genetic Susceptibility of Melanoma in Children, Adolescents and Young Adults - Novel Health Care Strategies for Melanoma in Children, Adolescents and Young Adults (MELCAYA)
Overview
The primary objective of this study is the identification of environmental and genetic factors involved in the risk and progression of melanoma in children, adolescents and young adults (CAYA). The secondary objectives are to generate a model integrating the genetic and environmental factors to estimate the risk of developing melanoma and improve the primary prevention of melanoma through evidence-based interpretation of environmental risk.
Detailed description
By retrieving data from several epidemiological and clinical registries across Europe it is aimed to integrate and maximize efforts in order to create a large dataset that serves for a comprehensive analysis of genetic and environmental factors influencing the etiology of melanoma in CAYA. The data will be combined with exposome information about climate and pollution for the development of a weighted risk score. Furthermore, germline high risk mutations and germline low-medium risk variants will be analyzed. Genome and transcriptome sequencing of blood and in selected cases tumour will provide the most comprehensive data to create a polygenic risk score for CAYA melanoma. Transcriptome data will help to identify and characterize the effect of variants of unknown significance in coding, intronic as well as regulatory regions. Tumour sequencing can provide additional information on functional relevance of variants, e.g. secondary hits in tumour tissue or second hits in tumour suppressor genes. Such identification will be highly advantageous to design prevention strategies for melanoma development in CAYA.
Primary outcome measures
- Identification of environmental and genetic factors involved in the risk and progression of melanoma in children, adolescents and young adults (CAYA) [Time frame: 01.01.2024 - 30.11.2025]
Secondary outcome measures (2)
- Generating a polygenic risk score for melanoma in CAYA by using the Lindeman-Merenda-Gold (LMG) method [Time frame: 01.06.2024 - 31.05.2026]
- Prevention strategies for melanoma development in CAYA [Time frame: 01.06.2025 - 30.09.2026]
Eligibility criteria
Inclusion criteria
- confirmed melanoma
- age until 30 years old
Exclusion criteria
- no available biological material
- no signed informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Italy · 2 centers
- University of Florence — Florence
- Istituto Nazionale del Tumori — Milan
Germany · 1 center
- Leibniz Research Institute for Environmental Medicine — Düsseldorf
Poland · 1 center
- Medical University of Gdánsk — Gdansk
Spain · 1 center
- Hospital Clínic de Barcelona — Barcelona
Sweden · 1 center
- Karolinska Institute — Solna
Identifiers
NCT: NCT06680323 · 834/2023BO2