MELCAYA - Novel Health Care Strategies for Melanoma in Children, Adolescents, and Young Adults - Work Package 3 (WP3)

Официальное название

Novel Health Care Strategies for Melanoma in Children, Adolescents, and Young Adults. Histological, Computational, and Molecular Pathology for Improved Diagnosis. (Mol-Mel). Work Package 3 (WP3)

Обзор

The aim of this study is to investigate a type of skin cancer, also known as melanoma, in children, adolescents, and young adults, who will be referred to as CAYA patients in this project. The need for this study arises because this disease, in CAYA patients, is still poorly understood due to its rarity in individuals under 30 years old. This often leads to difficulties in assessing its severity and, consequently, in deciding on the necessary treatments to ensure the patient\'s recovery. The goal of this study is to examine melanoma in CAYA patients in order to gather the information needed to provide better diagnoses for affected patients and, as a result, select appropriate treatments to fight the disease and promote the patient\'s full recovery. Additionally, the data collected will be used to create a Pan-European online platform that will allow doctors across the European Union to consult the obtained data and collaborate on particularly complex melanoma cases, always with the aim of ensuring the patient\'s full recovery in the shortest possible time.

Подробное описание

The Mol-Mel study will focus on different tasks and for each task different investigations will be carried out:

* 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.

Первичные конечные точки

• Primary objective - Hybrid taxonomy [Срок оценки: From enrollment at the end of 32 months]
• Primay objective - Histopathological and molecular features of pediatric melanoma [Срок оценки: From enrollment at the end of 32 months]

Вторичные конечные точки (3)

• Secondary Objective - Identification of biomarkers [Срок оценки: From enrollment at the end of 32 months]
• Secondary Objective - pan-European digital pathology platform [Срок оценки: From enrollment at the end of 32 months]
• Secondary Objective - Identification of prognostic and predictive biomarkers [Срок оценки: From enrollment at the end of 32 months]

Критерии участия

Критерии включения

• adolescent and childhood patients (\< 20 years) or young adults (\< 30 years)
• histologically confirmed diagnosis of melanoma or intermediate/ambiguous melanocytic neoplasm (i.e., melanocytomas, SAMPUS, IAMPUS and MELTUMP according to WHO classification)

Критерии исключения

• adult patients (\> 30 years of age)
• patients without histologically confirmed diagnosis of melanoma or intermediate/ambiguous melanocytic neoplasm

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• University of Florence — Florence

Публикации

• Pappo AS. Melanoma in children and adolescents. Eur J Cancer. 2003 Dec;39(18):2651-61. doi: 10.1016/j.ejca.2003.06.001. PMID 14642927
• 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. PMID 27020384
• 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. PMID 10333219
• 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. PMID 23395590
• 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. PMID 16806794
• 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 Canc PMID 30785015
• 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. PMID 29388632
• 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. PMID 19880040

Идентификаторы

NCT: NCT06602648 · 24680_bio

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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