About

Melanoma in childhood and adolescence is under-studied, lacking adequate preventive, diagnostic, and therapeutic strategies. The incidence of melanoma is reported to be about 1.3-1.6 per million in children under 15 years of age and 15 per million in 15-19 y.o., with increasing incidence in adolescents by 4.1% annually since 1997. Additionally, melanoma is among the most frequent solid tumors diagnosed in young adults, having in Europe an incidence of 6.6 per 100.000 and a mortality of 4 per million. Little is known about the interaction between genetic and environmental factors associated with melanoma risk in this context or in the progression from benign nevus to melanoma. Furthermore, lower sensitivity than in adults results in late diagnosis with poorer outcomes, when CAYA patients, particularly the children, could show a 90% 10-year survival rate from stage I/II disease. Thus, melanomas in children, adolescents and young adults (CAYA) represent a medical challenge.

IDENTIFY environmental and genetic risk factors for melanoma in CAYA.

ESTABLISH the molecular profiles of progression from benign congenital nevi to melanoma.

FACILITATE better international collaboration, standards, and melanoma taxonomy.

EVALUATE the clinical efficacy and safety of anti-PD1 antibodies in CAYA melanoma patients 

DEVELOP an AI-based diagnostic tool to distinguish the images of melanomas from images of nevi or other benign pigmented skin lesions.

CONDUCT rapid and non-invasive tools for risk and prognosis of melanoma in CAYA.

DESIGN health care system strategies on prevention and diagnosis of melanoma in CAYA and disseminate the results to ensure maximum impact and the widest possible coverage.

ENSURE patient research engagement and education throughout the project and its Implementation

Duration

12/2022 to 11/2026

 

Programme

Horizon Europe

HORIZON-MISS-2021-CANCER-02

Research & Innovation Action

 

Reference

101096667

WP1 aims to (1) identify risk factors involved in the development of melanoma in CAYA, including patients with L/GCMN using registry data; (2) characterize the exposome in CAYA with melanoma, including patients with L/GCMN; (3) enumerate molecular determinants of personal risk from endogenous or exogenous sources, and (4) test pre-clinical strategies to best model and thereby improve patient response.

WP2 aims to (1) identify the molecular profiles of all cellular states of progression from benign nevi to malignant melanoma in young patients with congenital predispositions, (2) longitudinally characterize the cell-free DNA (cfDNA) from young L/GCMN and melanoma patients, (3) improve early diagnosis, prevention and treatments for intermediate conditions such as large/giant congenital melanocytic nevi (L/GCMN) through evidence-based interpretation of personal risk from endogenous or exogenous sources, and (4) test pre-clinical strategies to best  model and thereby improve patient response.

WP3 seeks to (1) identify tumor tissue processing and quality control protocols, (2) develop a novel hybrid taxonomy (3) create a pan-European second opinion platform for collaboration between pathologist, and (4) facilitate European standardization and knowledge sharing of clinically validated biomarkers, tools and algorithms   

WP4 aims to (1) retrieve, in the early stage and metastatic disease, data on the activity and efficacy of anti PD1 antibodies administered to childhood, adolescent and young adult melanoma patients in the context of academic European centers, (2) evaluate acute and long-term toxicity of anti PD-1 antibodies in adolescent, childhood and young adult with early and advanced melanomas, (3) investigate in childhood, adolescent and young adult 

melanoma population, the impact of anti PD-1 antibodies on fertility, and (4) evaluate the incidence of second  cancers in CAYA with early and advanced melanomas treated with anti PD-1 therapy.

WP5 seeks to (1) to generate AI-based image analysis classifiers as melanoma risk prediction biomarkers and diagnostic assistance tools for CAYA melanoma early detection. The project will contribute the data that will be used to train and test the classifiers. Participating dermatologists and pathologists will contribute to data annotation and analyze the results of the XAI-based algorithms.

WP6 aims to (1) develop an AI-based solution for the quantitative prognosis of melanoma in CAYA, (2) implement an interpretability module of the outputs of the model, (3) create a new statistically coherent stratification and policy for melanoma in CAYA, (4)  design, produce, and test novel non-invasive sensing technologies.

WP7 aims to (1) develop guidance on the assessment of innovative technologies addressed to the prevention and diagnosis of melanoma in childhood, including advice on their transferability to EU health system under the current EU Health Technology Assessment Regulation, (2) assess the ethical, legal and social implications (ELSI) on implementing preventive and diagnostic health care schemes for melanoma in childhood, (3) design health care system strategies to inform policy decisions to be implemented in overcoming current gaps in EU markets on prevention and diagnosis of melanoma in childhood.

WP8 seeks to manage and implement effective, strategic communication, engagement and exploitation activities with the aim to increase awareness, acceptance and uptake of MELCAYA results at national, European and global levels.

WP9 aims to (1) ensure the engagement of European patient organizationsin the MELCAYA research and education of patients and patients advocates and at the same time assuring its results align with the melanoma patient community expectations and giving the social and humanities perspective to the project, (2) to facilitate regular contact between the melanoma patient community and consortium partners to ensure mutual learning, (3) to assure that conducting ethnographic research within our patient community, (4) to coordinate the involvement of the wider European melanoma community via the Melanoma Patient Network Europe (MPNE), including patients from CEE via Melanoma Patient Network in Central and Eastern Europe (MPN-CEE).

WP10 aims to ensure efficient administrative and financial management, to coordinate the MELCAYA project by monitoring the successful implementation of the different research activities within the agreed time and cost, through continuous quality assessment and monitoring of potential risks and their appropriate mitigation, to guarantee the implementation of the Grant Agreement and the Consortium Agreement, to deliver timely reporting on project progress, to manage the data generated, collected and processed by the project, to handle relevant ethical issues, as well as the open access of publications.

WP11 aims to ensure compliance with the ‘ethics requirements’ set out in this work package.

D1.1 Risk factors and exposome for melanomas in CAYA

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D1.5 ExpoMel initiation package

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D1.6 ExpoMel Midterm recruitment report

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D1.7 ExpoMel Report on the status of posting results in a repository

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D2.1 Partner registration status

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D2.2 Report on molecular data collection of L/GCMN

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D2.4 Mid-term report on quality control

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D2.6 NevustoMel initiation package

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D2.7 NevustoMel Midterm recruitment report

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D2.8 NevustoMel Report on the status of posting results in a repository

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D3.1 Standardized protocols for tumor tissue processing

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D3.2 Standardized protocols and procedures for melanoma sub-classification

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D3.5 Mol-Mel initiation package

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D3.7 Mol-Mel Report on the status of posting results in a repository

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D4.2 Immuno-Ped initiation package

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D4.3 Immuno-Ped Midterm recruitment report

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D4.4 Immuno-Ped Report on the status of posting results in a repository

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D4.5 Immuno-Ped II initiation package

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D4.6 Immuno-Ped II Midterm recruitment report

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D4.7 Immuno-Ped II Report on the status of posting results in a repository

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D5.4 AI-MEL initiation package

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D5.5 AI-MEL Midterm recruitment report

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D5.6 AI-MEL Report on the status of posting results in a repository

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D6.4 Precis-mel initiation package

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D6.5 Precis-mel Midterm recruitment report

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D6.6 Precis-mel Report on the status of posting results in a repository

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D7.1 Framework for assessing innovative HTs

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D7.2 Set of Health care system strategies

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D8.1 Dissemination & communication plan 1

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D8.2 Dissemination & communication plan 2

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D8.3 Dissemination & communication plan 3

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D8.4 Exploitation Strategy

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D8.5 Online and media presence 1

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D8.6 Online and media presence 2

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D8.7 Engagement summary report

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D8.8 Project Website

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D8.9 Common work plan for scientific collaboration under the ‘Understanding’ cluster

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D8.10 Common video and/or a common cluster brochure

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D9.1 Patient engagement plan

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D9.2 Impact assessment of patient engagement

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D9.3 Report on the methodology for ethnographic citizen science to understand barriers in CAYA patients

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D9.4 Citizen engagement summary report

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D9.5 Addressing inequalities recommendations

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D10.1 Project Management Plan

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D10.2 Quality Assurance and Risk Management Plan

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D10.3 Data Management Plan 1

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D10.4 Data Management Plan 2

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D10.5 Data Management Plan 3

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D10.6 Plan for ethic-legal monitoring & ethical submissions 1

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D10.7 Plan for ethic-legal monitoring & ethical submissions 2

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D10.8 Conclusions of common annual meeting of the ‘Understanding’ cluster 1

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D10.9 Conclusions of common annual meeting of the ‘Understanding’ cluster 2

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D10.10 Conclusions of common annual meeting of the ‘Understanding’ cluster 3

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D10.11 Conclusions of common annual meeting of the ‘Understanding’ cluster 4

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D10.12 Policy brief formulating recommendations based on the research and innovation strand of the ‘Understanding’ annual cluster meeting 1

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D10.13 Policy brief formulating recommendations based on the research and innovation strand of the ‘Understanding’ annual cluster meeting 2

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D10.14 Policy brief formulating recommendations based on the research and innovation strand of the ‘Understanding’ annual cluster meeting 3

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D10.15 Policy brief formulating recommendations based on the research and innovation strand of the ‘Understanding’ annual cluster meeting 4

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This project has received funding from the European Health and Digital Executive Agency under grant agreement No 101096667.

Project Office

August Pi i Sunyer Biomedical Research Institute (IDIBAPS)

Campus Casanova, Casanova, 143

08036 Barcelona

Contact

email: office@melcaya.eu