MELCAYA - Novel Health Care Strategies for Melanoma in Children, Adolescents, and Young Adults - Work Package 3 (WP3)
NCT ID: NCT06602648
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2024-04-17
2026-11-30
Brief Summary
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Detailed Description
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* Standardization and tissue quality control: The quality of the samples will then be determined using hematoxylin \& eosin (HE)-staining. If any quality issue is detected feedback will be sent to the clinical center responsible for providing the sample
* Histopathology \& computational pathology: Melanoma samples will undergo a central pathology review and analysis of conventional prognostic staging parameters. Diagnostically challenging neoplasms will be included in an "inter-observer agreement" carried out by different pathologist.Melanoma samples will also be charactered by single and multi-plex IHC in whole sections and tissue microarrays (TMA), and subjected to automated digital quantification. Spatial proteomics by automated ultra-high content imaging/MACSima Imaging Cyclic Staining (MICS) technology enables simultaneous analysis of hundreds of marker antigens on a single sample. Hundreds of antigens for single sample will be analysed via "Automated ultra-high content imaging/MACSima Imaging Cyclic Staining" (MICS) that will be performed on the novel automated ultra-high content imaging platform MACSimaTM (Miltenyi Biotec).
* Comprehensive somatic, transcriptional and DNA methylation landscape and data integration: DNA and RNA will be extracted by FFPE melanoma samples and characterized using whole-exome sequencing (WES), single nucleotide polymorphism (SNP) and RNA sequencing (RNAseq) arrays on matched tumor/normal pairs of samples. Then recurrent somatic aberrations, DNA methylation subclasses and patterns of tumor evolution will be characterized.
* Pan-European digital second opinion platform: this last task will focus on creating a pan-european second opinion platofrom in order to facilitate standardization of melanoma diagnosis and to share knowledge about biomarkers, algorithms and subtype classification.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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CAYA Melanoma patients
Patients under 30 years of age at the moment of melanoma diagnosis. The patients have been divided in Children (1-14 yrs), Adolescents (15-18 yrs) and Young Adults (18-30 yrs) based on the age of diagnosis.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* histologically confirmed diagnosis of melanoma or intermediate/ambiguous melanocytic neoplasm (i.e., melanocytomas, SAMPUS, IAMPUS and MELTUMP according to WHO classification)
Exclusion Criteria
* patients without histologically confirmed diagnosis of melanoma or intermediate/ambiguous melanocytic neoplasm
30 Years
ALL
No
Sponsors
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Tubingen University Hospital
UNKNOWN
Maria Sklodowska-Curie National Research Institute of Oncology
OTHER
Fondazione IRCCS ISTITUTO NAZIONALE TUMORI
UNKNOWN
Hospital Clinic of Barcelona
OTHER
Istanbul University
OTHER
University Of Perugia
OTHER
German Cancer Research Center
OTHER
University of Florence
OTHER
Responsible Party
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Daniela Massi
Professor
Principal Investigators
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Massi Daniela
Role: PRINCIPAL_INVESTIGATOR
University of Florence (UNIFI)
Locations
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University of Florence
Florence, Italy, Italy
Countries
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Central Contacts
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Facility Contacts
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Daniela Massi Professor
Role: backup
References
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Pappo AS. Melanoma in children and adolescents. Eur J Cancer. 2003 Dec;39(18):2651-61. doi: 10.1016/j.ejca.2003.06.001.
Wiesner T, Kutzner H, Cerroni L, Mihm MC Jr, Busam KJ, Murali R. Genomic aberrations in spitzoid melanocytic tumours and their implications for diagnosis, prognosis and therapy. Pathology. 2016 Feb;48(2):113-31. doi: 10.1016/j.pathol.2015.12.007. Epub 2016 Jan 18.
Barnhill RL, Argenyi ZB, From L, Glass LF, Maize JC, Mihm MC Jr, Rabkin MS, Ronan SG, White WL, Piepkorn M. Atypical Spitz nevi/tumors: lack of consensus for diagnosis, discrimination from melanoma, and prediction of outcome. Hum Pathol. 1999 May;30(5):513-20. doi: 10.1016/s0046-8177(99)90193-4.
Cordoro KM, Gupta D, Frieden IJ, McCalmont T, Kashani-Sabet M. Pediatric melanoma: results of a large cohort study and proposal for modified ABCD detection criteria for children. J Am Acad Dermatol. 2013 Jun;68(6):913-25. doi: 10.1016/j.jaad.2012.12.953. Epub 2013 Feb 8.
de Vries M, Vonkeman WG, van Ginkel RJ, Hoekstra HJ. Morbidity after inguinal sentinel lymph node biopsy and completion lymph node dissection in patients with cutaneous melanoma. Eur J Surg Oncol. 2006 Sep;32(7):785-9. doi: 10.1016/j.ejso.2006.05.003. Epub 2006 Jun 27.
Ferrari A, Brecht IB, Gatta G, Schneider DT, Orbach D, Cecchetto G, Godzinski J, Reguerre Y, Bien E, Stachowicz-Stencel T, Ost M, Magni C, Kearns P, Vassal G, Massimino M, Biondi A, Bisogno G, Trama A. Defining and listing very rare cancers of paediatric age: consensus of the Joint Action on Rare Cancers in cooperation with the European Cooperative Study Group for Pediatric Rare Tumors. Eur J Cancer. 2019 Mar;110:120-126. doi: 10.1016/j.ejca.2018.12.031. Epub 2019 Feb 19.
Saiyed FK, Hamilton EC, Austin MT. Pediatric melanoma: incidence, treatment, and prognosis. Pediatric Health Med Ther. 2017 Apr 18;8:39-45. doi: 10.2147/PHMT.S115534. eCollection 2017.
Jen M, Murphy M, Grant-Kels JM. Childhood melanoma. Clin Dermatol. 2009 Nov-Dec;27(6):529-36. doi: 10.1016/j.clindermatol.2008.09.011.
Related Links
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MELCAYA official website
Other Identifiers
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24680_bio
Identifier Type: -
Identifier Source: org_study_id
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