Periodic Reporting for period 1 - MELCAYA (Novel health care strategies for melanoma in children, adolescents and young adults)
Okres sprawozdawczy: 2022-12-01 do 2024-05-31
In childhood, adolescence and young adults (CAYA), melanoma is under-studied and non-existing tailored clinical guidelines and standardized approaches lead to a very low diagnostic accuracy. The MELCAYA project aims to understand risk factors and determinants of melanoma to improve the prevention, diagnosis and prognosis of melanomas in CAYAs. To achieve this goal, MELCAYA will focus on different areas, including the identification of environmental and genetic risk factors for melanoma in CAYA, the study of molecular profiles of progression from benign congenital nevi to melanoma, the development of new standards for melanoma taxonomy and the evaluation of the clinical efficacy and safety of anti-PD1 antibodies for the treatment of CAYA patients. Image-based robust and trustworthy machine learning tools and a pan-European second-opinion platform for better diagnosis will also be generated in this project. Moreover, the validation of minimally and non-invasive disruptive tools based on artificial intelligence and volatile organic compounds detection from exhaled breath and skin will be investigated, leading to earlier detection and more accurate prognosis of melanoma in CAYA. Finally, through the evidence gathered, MELCAYA will design and implement public health strategies and will actively involve patients and the general population. The results of the project will maximize its impact by making its data and results accessible and re-usable through integration into the UNCAN platform.
During its first 18 months, the project has made significant progress in different areas. A scoping review on melanoma risk factors in CAYA was conducted, data from population-based cancer registries identified and melanoma incidence in EU countries analyzed. Exposome analysis began, focusing on climatic zones and melanoma incidence rates. Regarding the molecular studies, sample inclusion criteria and sequencing protocols were defined. Preliminary work on the single-cell characterization of benign nevi/intermediate lesions and a cell-free DNA pilot study on large/giant melanocytic nevi has also been carried out.
Several virtual sessions with expert pathologists were organized to evaluate and select over 120 confirmed CAYA melanoma cases to be included in the MELCAYA molecular studies. Quality and sample cutting control protocols were defined, and a preliminary study to assess the viability of the HALO Link platform as a second opinion platform for pathologists was completed. Retrospective clinical data on anti-PD1 immunotherapy in pediatric melanoma (117 cases) was collected and analyzed. On top of this, set-up activities were completed for AI-based image analysis classifiers and the devices for non-invasive early melanoma detection (breath analyzer and wearable patch) produced. The approved clinical studies for these technologies will start in the coming months.
Additionally, the project reviewed national cancer plans for early diagnosis and prevention, developed evaluation frameworks for rare childhood cancer diagnostic technologies, and conducted a preliminary review of the associated ethical, legal, and social implications. Melanoma patient associations organized several workshops to evaluate the patient journey and facilitate feedback between consortium partners and the melanoma patient community on diagnostic technologies and policy gaps.
Several virtual sessions with expert pathologists were organized to evaluate and select over 120 confirmed CAYA melanoma cases to be included in the MELCAYA molecular studies. Quality and sample cutting control protocols were defined, and a preliminary study to assess the viability of the HALO Link platform as a second opinion platform for pathologists was completed. Retrospective clinical data on anti-PD1 immunotherapy in pediatric melanoma (117 cases) was collected and analyzed. On top of this, set-up activities were completed for AI-based image analysis classifiers and the devices for non-invasive early melanoma detection (breath analyzer and wearable patch) produced. The approved clinical studies for these technologies will start in the coming months.
Additionally, the project reviewed national cancer plans for early diagnosis and prevention, developed evaluation frameworks for rare childhood cancer diagnostic technologies, and conducted a preliminary review of the associated ethical, legal, and social implications. Melanoma patient associations organized several workshops to evaluate the patient journey and facilitate feedback between consortium partners and the melanoma patient community on diagnostic technologies and policy gaps.
MELCAYA will integrate for the first-time data from European cohorts and registries on genetic predisposition and epidemiology with exposome data to design melanoma prevention strategies. The project will investigate cell signalling pathways that lead to the transition from benign nevi to melanoma, an area that is still poorly understood. A hybrid taxonomy and clinical management system with a digital slide platform for pathologists will also be developed, which will enhance the standardization and knowledge sharing of clinically validated biomarkers, tools and algorithms at European level.
The project will provide the most extensive clinical information on anti PD-1 therapy for CAYA populations, which lack dedicated studies due to the rarity of the disease. AI-based tools for early melanoma detection based on dermatoscopic and histological images will be developed, reducing the need for unnecessary biopsies and missed diagnoses. Novel minimally invasive technologies based on the identification of volatile biomarkers (breath analyzer and skin patch), will be evaluated for melanoma identification and patient follow-up.
MELCAYA will also provide a framework for the evaluation of the aforementioned innovative technologies and guidance on how to assess the added value they bring to current care, taking into account not only technical considerations, but also their associated social, ethical and legal implications. European melanoma patient organizations will shape the development of these tools through different touchpoints with project partners. The expected outcome is the implementation of health policy strategies complying with the legal framework and ethical standards of the EU.
The project will provide the most extensive clinical information on anti PD-1 therapy for CAYA populations, which lack dedicated studies due to the rarity of the disease. AI-based tools for early melanoma detection based on dermatoscopic and histological images will be developed, reducing the need for unnecessary biopsies and missed diagnoses. Novel minimally invasive technologies based on the identification of volatile biomarkers (breath analyzer and skin patch), will be evaluated for melanoma identification and patient follow-up.
MELCAYA will also provide a framework for the evaluation of the aforementioned innovative technologies and guidance on how to assess the added value they bring to current care, taking into account not only technical considerations, but also their associated social, ethical and legal implications. European melanoma patient organizations will shape the development of these tools through different touchpoints with project partners. The expected outcome is the implementation of health policy strategies complying with the legal framework and ethical standards of the EU.