Identification of Risk Factors, Exposomics and Genetic Susceptibility of Melanoma in Children, Adolescents and Young Adults

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A - 30 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - confirmed melanoma.
  • - age until 30 years old.

Exclusion Criteria:

  • - no available biological material.
- no signed informed consent

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06680323
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital Tuebingen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Germany, Italy, Poland, Spain, Sweden
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma, Spitzoid Melanoma, Congenital Nevi
Additional Details

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.

Arms & Interventions

Arms

: Classic melanoma

Classic malignant melanoma under the age of 30 years For patients with available biospecimen, the germline genome, transcriptome and in selected cases tumour normal exomes will be sequenced.

: Spitzoid melanoma

Spitzoid melanoma under the age of 30 years For patients with available biospecimen, the germline genome, transcriptome and in selected cases tumour normal exomes will be sequenced.

: Other melanoma

Other melanoma as melanoma on congenital nevi under the age of 30 years For patients with available biospecimen, the germline genome, transcriptome and in selected cases tumour normal exomes will be sequenced.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Düsseldorf, Germany

Status

Active, not recruiting

Address

Leibniz Research Institute for Environmental Medicine

Düsseldorf, , 40225

University of Florence, Florence, Italy

Status

Active, not recruiting

Address

University of Florence

Florence, , 50121

Istituto Nazionale del Tumori, Milan, Italy

Status

Active, not recruiting

Address

Istituto Nazionale del Tumori

Milan, , 20133

Medical University of Gdánsk, Gdańsk, Poland

Status

Recruiting

Address

Medical University of Gdánsk

Gdańsk, , 80-210

Site Contact

Ewa Bien, MD, PhD

[email protected]

+49707183773

Hospital Clínic de Barcelona, Barcelona, Spain

Status

Recruiting

Address

Hospital Clínic de Barcelona

Barcelona, , 08036

Site Contact

Susana Puig Sardá, MD, PhD

[email protected]

+49707183773

Karolinska Institute, Solna, Sweden

Status

Recruiting

Address

Karolinska Institute

Solna, , 17177

Site Contact

Hildur Helgadottir, MD

[email protected]

+49707183773

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