Novel health care strategies for melanoma in children, adolescents and young adults

Leistungen

List of partners identified in level of involvement.

Report when 50% of the study population is recruited. The report will include an overview of the number of recruited participants by clinical sites, any problems in recruitment and, if applicable, a detailed description of implemented and planned measures to compensate for any incurred delays.

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

Report on policy brief formulating recommendations based on the research and innovation strand of the ‘Understanding’ annual cluster meeting

AI-MEL Midterm recruitment report

Report when 50% of the study population is recruited. The report will include an overview of the number of recruited participants by clinical sites, any problems in recruitment and, if applicable, a detailed description of implemented and planned measures to compensate for any incurred delays.

Report on molecular data collection of L/GCMN

Document detailing the results of molecular studies previously performed in L/GCMN

Standardized protocols and procedures for melanoma sub-classification

Document detailing the standardized protocols and procedures for melanoma sub-classification including staining, immunohistochemistry and molecular studies (FISH, NGS, others)

Immuno-Ped initiation package

- Registration number of the clinical study in a registry meeting WHO Registry criteria.- Final version of study protocol as approved by the regulators/ethics committee.- Regulatory and ethics approvals required for the enrolment of the first study participant.Study protocol will include information about if and how the incidental (or secondary) findings will be communicated to participants and how the personal data will be processed. Study protocol will also include information about how the retrospective and prospective personal data will be processed and also about the anonymization/pseudoanonymisation techniques that will be implemented.

Standardized protocols for tumor tissue processing

Document detailing the standardized protocols for tumor tissue processing (inclusion, orientation of the sample, sectioning, etc)

Conclusions of common annual meeting of the ‘Understanding’ cluster 3

Report on the conclusions of common annual meeting of the ‘Understanding’ cluster

Dissemination & communication plan 1

Document describing the dissemination and communication plan

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

Report on policy brief formulating recommendations based on the research and innovation strand of the ‘Understanding’ annual cluster meeting

Project Management Plan

Document describing the management plan for MELCAYA project

Plan for ethic-legal monitoring & ethical submissions 1

Document detailing the plan for ethic-legal monitoring & ethical submissions

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

Report on the common work plan for scientific collaboration under the ‘Understanding’ cluster

NevustoMel initiation package

- Registration number of the clinical study in a registry meeting WHO Registry criteria.- Final version of study protocol as approved by the regulators/ethics committee.- Regulatory and ethics approvals required for the enrolment of the first study participant.Study protocol will include information about if and how the incidental (or secondary) findings will be communicated to participants and how the personal data will be processed. Study protocol will also include information about how the retrospective and prospective personal data will be processed and also about the anonymization/pseudoanonymisation techniques that will be implemented.

Immuno-Ped Midterm recruitment report

Report when 50% of the study population is recruited. The report will include an overview of the number of recruited participants by clinical sites, any problems in recruitment and, if applicable, a detailed description of implemented and planned measures to compensate for any incurred delays.

Immuno-Ped II initiation package

- Registration number of the clinical study in a registry meeting WHO Registry criteria.- Final version of study protocol as approved by the regulators/ethics committee.- Regulatory and ethics approvals required for the enrolment of the first study participant.Study protocol will include information about if and how the incidental (or secondary) findings will be communicated to participants and how the personal data will be processed. Study protocol will also include information about how the retrospective and prospective personal data will be processed and also about the anonymization/pseudoanonymisation techniques that will be implemented.

Patient engagement plan

Detailed plan for patient engagement

AI-MEL initiation package

- Registration number of the clinical study in a registry meeting WHO Registry criteria.- Final version of study protocol as approved by the regulators/ethics committee.- Regulatory and ethics approvals required for the enrolment of the first study participant.Study protocol will include information about if and how the incidental (or secondary) findings will be communicated to participants and how the personal data will be processed. Study protocol will also include information about how the retrospective and prospective personal data will be processed and also about the anonymization/pseudoanonymisation techniques that will be implemented.AI-MEL study protocol will include information about how humans will maintain meaningful control over the decision-making process for the use of the prediction and diagnostic tool to be developed in the project.

Mol-Mel Midterm recruitment report

Report when 50% of the study population is recruited. The report will include an overview of the number of recruited participants by clinical sites, any problems in recruitment and, if applicable, a detailed description of implemented and planned measures to compensate for any incurred delays.

Plan for ethic-legal monitoring & ethical submissions 2

Document detailing the plan for ethic-legal monitoring & ethical submissions

Conclusions of common annual meeting of the ‘Understanding’ cluster 1

Report on the conclusions of common annual meeting of the ‘Understanding’ cluster

Dissemination & communication plan 2

Document describing the dissemination and communication plan

Exploitation strategy

Document detailing the strategy for exploitation of the results

Precis-mel initiation package

- Registration number of the clinical study in a registry meeting WHO Registry criteria.- Final version of study protocol as approved by the regulators/ethics committee.- Regulatory and ethics approvals required for the enrolment of the first study participant.Study protocol will include information about if and how the incidental (or secondary) findings will be communicated to participants and how the personal data will be processed. Study protocol will also include information about how the retrospective and prospective personal data will be processed and also about the anonymization/pseudoanonymisation techniques that will be implemented.The study protocol will include information about how humans will maintain meaningful control over the decision-making process for the use of the prediction and diagnostic tool to be developed in the project. No further deliverables will be required.

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

Report on policy brief formulating recommendations based on the research and innovation strand of the ‘Understanding’ annual cluster meeting

NevustoMel Midterm recruitment report

Report when 50% of the study population is recruited. The report will include an overview of the number of recruited participants by clinical sites, any problems in recruitment and, if applicable, a detailed description of implemented and planned measures to compensate for any incurred delays.

Mid-term report on quality control

Document reporting quality issues identified and measures for correction.

Quality Assurance and Risk Management Plan

Document detailing the Quality Assurance and Risk Management Plan

ExpoMel initiation package

- Registration number of the clinical study in a registry meeting WHO Registry criteria.- Final version of study protocol as approved by the regulators/ethics committee.- Regulatory and ethics approvals required for the enrolment of the first study participant.Study protocol will include information about if and how the incidental (or secondary) findings will be communicated to participants and how the personal data will be processed. Study protocol will also include information about how the retrospective and prospective personal data will be processed and also about the anonymization/pseudoanonymisation techniques that will be implemented.

Framework for assessing innovative HTs

Document describing the framework for assessing innovative Health technologies

Mol-Mel initiation package

- Registration number of the clinical study in a registry meeting WHO Registry criteria.- Final version of study protocol as approved by the regulators/ethics committee.- Regulatory and ethics approvals required for the enrolment of the first study participant.Study protocol will include information about if and how the incidental (or secondary) findings will be communicated to participants and how the personal data will be processed. Study protocol will also include information about how the retrospective and prospective personal data will be processed and also about the anonymization/pseudoanonymisation techniques that will be implemented.

Conclusions of common annual meeting of the ‘Understanding’ cluster 2

Report on the conclusions of common annual meeting of the ‘Understanding’ cluster

Common video and/or a common cluster brochure

Video and/or common cluster brochure of the projects included in the Mission Cancer Cluster 'Understanding'.

Project Website

MELCAYA webpage with public and private domains

Online and media presence 1

Document with the summary of all on line MELCAYA post, citations and interactions

Data Management Plan 3

Document detailing the Data Management PlanThe preparation of the Data Management Plan will include a common chapter onthe ‘Understanding’ cluster. The aim of the chapter is to addresscommonalities in data standards, data validation, data protection andfostering data exchange, in particular when it comes to sharing project datawith a future federated UNCAN.eu data platform. Therefore, interactions areenvisaged with the 4.UNCAN.eu (http://uncaninitiative.eu/) coordination andsupport action which is preparing a blueprint for UNCAN.eu

Data Management Plan 1

Document detailing the Data Management PlanThe preparation of the Data Management Plan will include a common chapter onthe ‘Understanding’ cluster. The aim of the chapter is to addresscommonalities in data standards, data validation, data protection andfostering data exchange, in particular when it comes to sharing project datawith a future federated UNCAN.eu data platform. Therefore, interactions areenvisaged with the 4.UNCAN.eu (http://uncaninitiative.eu/) coordination andsupport action which is preparing a blueprint for UNCAN.eu.

Data Management Plan 2

Document detailing the Data Management PlanThe preparation of the Data Management Plan will include a common chapter onthe ‘Understanding’ cluster. The aim of the chapter is to addresscommonalities in data standards, data validation, data protection andfostering data exchange, in particular when it comes to sharing project datawith a future federated UNCAN.eu data platform. Therefore, interactions areenvisaged with the 4.UNCAN.eu (http://uncaninitiative.eu/) coordination andsupport action which is preparing a blueprint for UNCAN.eu

Veröffentlichungen

Ethical, Legal, and Social Assessment of AI-Based Technologies for Prevention and Diagnosis of Rare Diseases in Health Technology Assessment Processes

Autoren: Pietro Refolo; Costanza Raimondi; Violeta Astratinei; Livio Battaglia; Josep M. Borràs; Paula Closa; Alessandra Lo Scalzo; Marco Marchetti; Sonia Muñoz-López; Laura Sampietro-Colom; Dario Sacchini
Veröffentlicht in: Healthcare, 2025, ISSN 2227-9032
Herausgeber: MDPI
DOI: 10.3390/HEALTHCARE13070829

Efficacy of anti PD-1 therapy in children and adolescent melanoma patients (MELCAYA study)

Autoren: Mario Mandalà, Andrea Ferrari, Ines B. Brecht, Karijn PM Suijkerbuijk, Linda Maschke, Diana Giannarelli, Alice Indini, Martina Ubaldi, Giulia Pecci, Victoria Atkinson, Hildur Helgadottir, Stefano Chiaravalli, Naima Benannoune, Caroline Robert, Pawel Teterycz, Piotr Rutkowski, Susana Puig, Gabriele Madonna, Rejin Kebudi, Shirly Grynberg, Lidia MRB Arantes, Ewa Bien, Malgorzata Krawczyk, Maria Debora De Pasquale, Miranda P. Dierselhuis, Daniela Massi, Georgina V. Long, Paolo Antonio Ascierto, Alexander M.M. Eggermont
Veröffentlicht in: European Journal of Cancer, Ausgabe 211, 2024, ISSN 0959-8049
Herausgeber: Elsevier BV
DOI: 10.1016/J.EJCA.2024.114305

Predictive and Prognostic Factors in Melanoma Central Nervous System Metastases-A Cohort Study

Autoren: Estefania Serra, Álvaro Abarzua-Araya, Ana Arance, Roberto Martin-Huertas, Francisco Aya, María Lourdes Olondo, Daniel Rizo-Potau, Josep Malvehy, Susana Puig, Cristina Carrera, Sebastian Podlipnik
Veröffentlicht in: Cancers, 2024, ISSN 2072-6694
Herausgeber: MDPI
DOI: 10.3390/CANCERS16122272

European Journal of Cancer

Autoren: Indini, Alice; Didoné, Fabio; Massi, Daniela; Puig, Susana; Casadevall, Jordi Rubio; Bennett, Damien; Katalinic, Alexander; Sanvisens, Arantza; Ferrari, Andrea; Lasalvia, Paolo; Demuru, Elena; Ragusa, Rosalia; Mayer-da-Silva, Alexandra; Blum, Marcel; Mousavi, Mohsen; Kuehni, Claudia; Mihor, Ana; Mandalà, Mario; Trama, Annalisa
Veröffentlicht in: European Journal of Cancer, 2024, ISSN 0959-8049
Herausgeber: Elsevier
DOI: 10.48620/77106

Análisis multicéntrico del manejo quirúrgico y tratamiento adyuvante de los pacientes con melanoma y positividad en la biopsia selectiva del ganglio centinela

Autoren: E. Samaniego-González, S. Podlipnik, S. Ribero, E. Nagore, A. Boada, J. Cañueto, S. Paradela, B. de Unamuno, P. Rodríguez-Jiménez, S. Puig, J. Malvehy, C. Carrera, G. Roccuzzo, C. Requena, E. Manrique-Silva, N. Richarz, A. Ruiz-Villanueva, V. Traves, S. España-Fernández, R. Botella-Estrada, M.A. González-Morán, A. Tejera-Vaquerizo
Veröffentlicht in: Actas Dermo-Sifiliográficas, Ausgabe 116, 2025, ISSN 0001-7310
Herausgeber: Elsevier BV
DOI: 10.1016/J.AD.2024.07.017

Acta Dermato-Venereologica

Autoren: Samaniego-González, E.; Podlipnik, S.; Ribero, S.; Nagore, E.; Boada, A.; Cañueto, J.; Paradela, S.; de Unamuno, B.; Rodríguez-Jiménez, P.; Puig, S.; Malvehy, J.; Carrera, C.; Roccuzzo, G.; Requena, C.; Manrique-Silva, E.; Richarz, N.; Ruiz-Villanueva, A.; Traves, V.; España-Fernández, S.; Botella-Estrada, R.; González-Morán, M. A.; Tejera-Vaquerizo, A.
Veröffentlicht in: Actas Dermo-Sifiliográficas, 2025, ISSN 0001-5555
Herausgeber: Taylor & Francis
DOI: 10.1016/J.AD.2024.07.017

Policy Challenges in Ultra-Rare Cancers: Ethical, Social, and Legal Implications of Melanoma Prevention and Diagnosis in Children, Adolescents, and Young Adults

Autoren: Pietro Refolo; Costanza Raimondi; Livio Battaglia; Josep M. Borràs; Paula Closa; Alessandra Lo Scalzo; Marco Marchetti; Sonia Muñoz López; Joan Prades Perez; Laura Sampietro-Colom; Dario Sacchini
Veröffentlicht in: Healthcare, 2025, ISSN 2227-9032
Herausgeber: MDPI
DOI: 10.3390/HEALTHCARE13030321

Cancers

Autoren: Estefania Serra; Álvaro Abarzua-Araya; Ana Arance; Roberto Martin-Huertas; Francisco Aya; María Lourdes Olondo; Daniel Rizo-Potau; Josep Malvehy; Susana Puig; Cristina Carrera; Sebastian Podlipnik
Veröffentlicht in: Cancers, 2024, ISSN 2072-6694
Herausgeber: MDPI
DOI: 10.3390/CANCERS16122272

Braf-mutant Schwann cells divert to a repair phenotype to induce congenital demyelinating neuropathy

Autoren: Elise Marechal, Patrice Quintana, Daniel Aldea, Grégoire Mondielli, Nathalie Bernard-Marissal, Mathias Moreno, Valérie Delague, Lauren A. Weiss, Anne Barlier, Heather C. Etchevers
Veröffentlicht in: bioRxiv, 2024, ISSN 1531-6386
Herausgeber: bioRxiv
DOI: 10.1101/2024.04.24.590951

Acral Melanoma in the Caucasian Population: A Comprehensive Cohort Study on Epidemiological, Clinicopathological, and Prognostic Features

Autoren: J. Angel-Baldo, S. Podlipnik, A. Azón, A. Boada, A. Arrieta, J. Marcoval, C. López-Sánchez, M. Sàbat, S. Segura, D. Bodet, N. Curcó, D. Lopez-Castillo, J. Solà, M. Quintana-Codina, C. Baliu-Piqué, M. Just-Sarobé, S. Martín-Sala, J. Malvehy, S. Puig, C. Carrera, R.M. Marti, Clara Matas-Nadal, Xavier Soria, Sonia Gatius, Felip Vilardell, Inma Gil, Cristina Grau, Fani Martínez, Nelson Lobos, Oriol Yélamos, Joan Dalmau, Carlos González-Cruz, Helena Hilari, Paola Pasquali, Marc Sagristà, María Rosa Olivella-Garcés, Montserrat Bonfill-Ortí, Josep Ramón Ferreres, Ane Jaka, Ariadna Quer, Nina Richarz, Inés Zarzoso Muñoz, Emili Masferrer, Pedro Zaballos, Manel Formigon, Loida Galvany, Marta Alegre, Anna Sánchez-Puigdollers, Nerea Mohino-Farré
Veröffentlicht in: Actas Dermo-Sifiliográficas, Ausgabe 116, 2025, ISSN 0001-7310
Herausgeber: Elsevier BV
DOI: 10.1016/J.AD.2024.10.060

Deconvoluted Methylation Profiles Discriminate between Closely Related Melanocytic Nevi

Autoren: Daniel Aldea, Nicolas Macagno, Elise Marechal, Mathias Moreno, Pauline Romanet, Morgane Pertuit, Jérémy Garcia, Nathalie Degardin, Stéphanie Mallet, Isabelle James, Guillaume Captier, Anne Barlier, Heather C. Etchevers
Veröffentlicht in: Journal of Investigative Dermatology, Ausgabe 145, 2025, ISSN 0022-202X
Herausgeber: Elsevier BV
DOI: 10.1016/J.JID.2024.10.595

Challenges in developing a digital pathology consultation network: insights from the MELCAYA experience

Autoren: Dario Di Gangi, Roberta Gugliotta, Filippo Ugolini, Anna Szumera-Ciećkiewicz, Llucia Alos, Natalia Castrejón, Stephan Forchhammer, Barbara Valeri, Nicolas Macagno, Sule Ozturk Sari, Ozge Hurdogan, Sokol Sina, Sylvie Fraitag, Valerio Gaetano Vellone, Chiara Trambaiolo, Rita Alaggio, Sabrina Rossi, Giovanni Arcuri, Daniela Massi, Claudio Conti
Veröffentlicht in: EJC Skin Cancer, Ausgabe 3, 2025, ISSN 2772-6118
Herausgeber: Elsevier BV
DOI: 10.1016/J.EJCSKN.2025.100742

Mobile Diagnostic Clinics

Autoren: Baron, Roni; Haick, Hossam
Veröffentlicht in: ACS Sensors, 2024, ISSN 2379-3708
Herausgeber: American Chemical Society (ACS)
DOI: 10.1021/ACSSENSORS.4C00636

UV-radiation and MC1R germline mutations are risk factors for the development of conventional and spitzoid melanomas in children and adolescents

Autoren: Alexandra Liebmann, Jakob Admard, Sorin Armeanu-Ebinger, Hannah Wild, Michael Abele, Axel Gschwind, Olga Seibel-Kelemen, Christian Seitz, Irina Bonzheim, Olaf Riess, German Demidov, Marc Sturm, Malou Schadeck, Michaela Pogoda, Ewa Bien, Malgorzata Krawczyk, Eva Jüttner, Thomas Mentzel, Maja Cesen, Elke Pfaff, Michal Kunc, Stephan Forchhammer, Andrea Forschner, Ulrike Leiter-Stöppke, Thomas K. Eigentler, Dominik T. Schneider, Christopher Schroeder, Stephan Ossowski, Ines B. Brecht
Veröffentlicht in: eBioMedicine, Ausgabe 96, 2023, ISSN 2352-3964
Herausgeber: Elsevier BV
DOI: 10.1016/J.EBIOM.2023.104797

Cutaneous Adverse Reactions to Apalutamide: Case Series with Clinical and Pathological Correlations

Autoren: Javier Gil-Lianes; Victoria Amat-Samaranch; Priscila Giavedoni; Antoni Vilaseca; Julián Córdoba Sánchez; Francesc Alamon-Reig; Paola Castillo; Adriana P. Garcia; Mariona Pascal; Cristina Carrera
Veröffentlicht in: Acta Dermato-Venereologica, 2024, ISSN 1651-2057
Herausgeber: Medical Journals Sweden
DOI: 10.2340/ACTADV.V104.40719

Actas Dermo-Sifiliograficas

Autoren: Àngel-Baldó, Joan; Segura Tigell, Sonia; Network of Melanoma Centers of Catalonia
Veröffentlicht in: instname:Universitat Pompeu Fabra, 2025, ISSN 0001-7310
Herausgeber: Actas Dermo-Sifiliográficas
DOI: 10.1016/J.AD.2024.10.060

EBioMedicine

Autoren: Alexandra Liebmann; Jakob Admard; Sorin Armeanu-Ebinger; Hannah Wild; Michael Abele; Axel Gschwind; Olga Seibel-Kelemen; Christian Seitz; Irina Bonzheim; Olaf Riess; German Demidov; Marc Sturm; Malou Schadeck; Michaela Pogoda; Ewa Bien; Malgorzata Krawczyk; Eva Jüttner; Thomas Mentzel; Maja Cesen; Elke Pfaff; Michal Kunc; Stephan Forchhammer; Andrea Forschner; Ulrike Leiter-Stöppke; Thomas K. Eigentler; Dominik T. Schneider; Christopher Schroeder; Stephan Ossowski; Ines B. Brecht
Veröffentlicht in: eBioMedicine, Ausgabe Elsevier, 2023, ISSN 2352-3964
Herausgeber: Elsevier BV
DOI: 10.1016/J.EBIOM.2023.104797

European Journal of Cancer

Autoren: Mandalà, Mario; Ferrari, Andrea; Brecht, Ines B.; Suijkerbuijk, Karijn PM; Maschke, Linda; Giannarelli, Diana; Indini, Alice; Ubaldi, Martina; Pecci, Giulia; Atkinson, Victoria; Helgadottir, Hildur; Chiaravalli, Stefano; Benannoune, Naima; Robert, Caroline; Teterycz, Pawel; Rutkowski, Piotr; Puig, Susana; Madonna, Gabriele; Kebudi, Rejin; Grynberg, Shirly; Arantes, Lidia MRB; Bien, Ewa; Krawczyk, Malgorzata; Pasquale, Maria Debora De; Dierselhuis, Miranda P.; Massi, Daniela; Long, Georgina V.; Ascierto, Paolo Antonio; Eggermont, Alexander M. M.
Veröffentlicht in: European Journal of Cancer, 2024, ISSN 0959-8049
Herausgeber: Pergamon Press Ltd.
DOI: 10.1016/J.EJCA.2024.114305

Incidence and prognosis of cutaneous melanoma in European adolescents and young adults (AYAs): EUROCARE-6 retrospective cohort results

Autoren: Alice Indini, Fabio Didoné, Daniela Massi, Susana Puig, Jordi Rubio Casadevall, Damien Bennett, Alexander Katalinic, Arantza Sanvisens, Andrea Ferrari, Paolo Lasalvia, Elena Demuru, Rosalia Ragusa, Alexandra Mayer-da-Silva, Marcel Blum, Mohsen Mousavi, Claudia Kuehni, Ana Mihor, Mario Mandalà, Annalisa Trama
Veröffentlicht in: European Journal of Cancer, Ausgabe 213, 2024, ISSN 0959-8049
Herausgeber: Elsevier BV
DOI: 10.1016/J.EJCA.2024.115079

Identity crisis: stemness in the human melanocyte lineage

Autoren: Heather C. Etchevers
Veröffentlicht in: Pigment Cell and Melanoma Research, 2025
Herausgeber: Wiley
DOI: 10.1111/PCMR.70045

Integrative epigenetic and spatial mapping of melanoma development in large congenital melanocytic nevus

Autoren: Daniel Aldea, Israa Fakih, Nicolas Macagno, Mathias Moreno, Anne Barlier, Heather C. Etchevers
Veröffentlicht in: Pigment Cell and Melanoma Research, 2025
Herausgeber: Wiley
DOI: 10.1111/PCMR.70045

Leistungen

Veröffentlichungen

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