MelanomaExpoMelNCT06680323
Identification of Risk Factors, Exposomics and Genetic Susceptibility of Melanoma in Children, Adolescents and Young Adults
An observational study of Melanoma and Spitzoid Melanoma, run by University Hospital Tuebingen at 6 sites in 5 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Melanoma, Spitzoid Melanoma, Congenital Nevi
- How many people
- 200 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 1 Jan 2024to 31 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 years
- All sexes
- Child, Adult
Study population: Due to its registry-based retrospective study, no formal recruitment of patients will occur in ExpoMel. Data and samples will be obtained from the following registries and associated biobanks: * Catalonia Melanoma Network through Hospital Clinic Barcelona * The German Registry for Rare Pediatric Tumours (STEP) of the German Society for Pediatric Oncology and Hematology * Swedish Melanoma Registry (SweMR) through Karolinska Institute * Public Pathology Database of the Netherlands (PALGA) through Princess Maxima Center for Children OncologyCentral Registry Malignant Melanoma of the German Dermatological Society (CMMR) * Polish Pediatric Rare Tumor Study group and selected Eastern/Southern Europe countries cooperating within the European Cooperative Study Group for Pediatric Rare Tumors (EXPERT) through the Medical University Gdansk
Who may be able to join
- confirmed melanoma
- age until 30 years old
Who cannot join
- no available biological material
- no signed informed consent
Trial locations and contacts
6 sites in 5 countries.
Christopher Schroeder, MD contact
6 sites in 5 countries
Italy2 sites
- Active, not recruiting
University of Florence
Florence, 50121
- Active, not recruiting
Istituto Nazionale del Tumori
Milan, 20133
Germany1 site
- Active, not recruiting
Leibniz Research Institute for Environmental Medicine
Düsseldorf, 40225
Poland1 site, 1 recruiting
- Recruiting
Medical University of Gdánsk
Gdansk, 80-210
Ewa Bien, MD, PhD
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
Susana Puig Sardá, MD, PhD
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institute
Solna, 17177
Hildur Helgadottir, MD
About this study
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)
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.
Read the 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.
- Conditions
- Melanoma, Spitzoid Melanoma, Congenital Nevi
- Keywords
- etiology, melanoma, children, adolescents, young adults, genetic predisposition, epidemiology, exposomes
- Medical subject headings
- Melanoma, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of environmental and genetic factors involved in the risk and progression of melanoma in children, adolescents and young adults (CAYA)
By retrieving data from several epidemiological and clinical registries across Europe we aim to create a large dataset that serves for a comprehensive analysis of genetic and environmental factors influencing the etiology of melanoma in CAYA. Data on climate variables such as surface temperature, solar radiation, and air pollutants will be collected from ground-based instruments, such as air quality monitoring stations, and satellites and reanalysis data from the Copernicus Atmosphere Monitoring Service (CAMS). Data analysis from genome sequencing will be done using established bioinformatic pipelines and combined with exposome information about climate and pollution for the development of a weighted risk score.
Measured: 01.01.2024 - 30.11.2025
Secondary outcomes (2)
Generating a polygenic risk score for melanoma in CAYA by using the Lindeman-Merenda-Gold (LMG) method
Genome and transcriptome sequencing of blood and in selected cases tumour will provide the most comprehensive data to create a polygenic risk score for melanoma in CAYA.
We will develop a weighted risk score for each environmental factor, which comprises the effects of several variables measuring the respective risk factor. Additionally, a weighted risk score for the epigenetic variables will be build. To estimate the relative contribution of environmental and epigenetic factors we will calculate the relative importance (proportion of explained variance) of the weighted risk scores in an ordinary linear regression model using the Lindeman-Merenda-Gold (LMG) method.
Measured: 01.06.2024 - 31.05.2026
Prevention strategies for melanoma development in CAYA
The detected risk factors and determinants will be used by health professionals to update clinical guidelines for prevention, screening and early detection of melanoma in CAYA. Health care system strategies will be implemented in European countries overcoming current gaps in European countries on prevention and diagnosis of melanoma in CAYA. The success will be measured by incidence rates of melanoma.
Measured: 01.06.2025 - 30.09.2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start1 Jan 2024
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, University Of Perugia, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Karolinska University Hospital, Leibniz Research Institute for Environmental Medicine Düsseldorf, Princess Maxima Center for Pediatric Oncology, Medical University of Gdansk
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680323
- Sponsor's protocol ID
- 834/2023BO2
- Acronym
- ExpoMel
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06680323
- Acronym / sponsor ID
- ExpoMel / 834/2023BO2
- Conditions
- Melanoma, Spitzoid Melanoma, Congenital Nevi
- Keywords
- etiology, melanoma, children, adolescents, young adults, genetic predisposition, epidemiology, exposomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, University Of Perugia, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Karolinska University Hospital, Leibniz Research Institute for Environmental Medicine Düsseldorf, Princess Maxima Center for Pediatric Oncology, Medical University of Gdansk
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Due to its registry-based retrospective study, no formal recruitment of patients will occur in ExpoMel. Data and samples will be obtained from the following registries and associated biobanks: * Catalonia Melanoma Network through Hospital Clinic Barcelona * The German Registry for Rare Pediatric Tumours (STEP) of the German Society for Pediatric Oncology and Hematology * Swedish Melanoma Registry (SweMR) through Karolinska Institute * Public Pathology Database of the Netherlands (PALGA) through Princess Maxima Center for Children OncologyCentral Registry Malignant Melanoma of the German Dermatological Society (CMMR) * Polish Pediatric Rare Tumor Study group and selected Eastern/Southern Europe countries cooperating within the European Cooperative Study Group for Pediatric Rare Tumors (EXPERT) through the Medical University Gdansk
Key inclusion criteria (2 listed)
- confirmed melanoma
- age until 30 years old
Key exclusion criteria (2 listed)
- no available biological material
- no signed informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
By retrieving data from several epidemiological and clinical registries across Europe we aim to create a large dataset that serves for a comprehensive analysis of genetic and environmental factors influencing the etiology of melanoma in CAYA. Data on climate variables such as surface temperature, solar radiation, and air pollutants will be collected from ground-based instruments, such as air quality monitoring stations, and satellites and reanalysis data from the Copernicus Atmosphere Monitoring Service (CAMS). Data analysis from genome sequencing will be done using established bioinformatic pipelines and combined with exposome information about climate and pollution for the development of a weighted risk score.
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Schroeder, MD contact
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma and Spitzoid Melanoma, run by University Hospital Tuebingen at 6 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy, Germany, Poland, Spain, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ines B Brecht, MD, PhD (+49707183773, ines.brecht@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.