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NCT Number: NCT06602648

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

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.

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Key information

Conditions

Melanoma of Skin Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

Up to 30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Primary objective - Hybrid taxonomy

    Time frame: From enrollment at the end of 32 months

    Integrate histopathology and molecular analyses to provide a novel hybrid taxonomy of melanoma in CAYA.

  2. Primay objective - Histopathological and molecular features of pediatric melanoma

    Time frame: From enrollment at the end of 32 months

    Assess the histopathological and molecular features of pediatric melanomas.

Secondary outcomes

  1. Secondary Objective - Identification of biomarkers

    Time frame: From enrollment at the end of 32 months

    Identify prognostic biomarkers in the context of immunotherapy and targeted therapy.

  2. Secondary Objective - pan-European digital pathology platform

    Time frame: From enrollment at the end of 32 months

    Create a pan-European digital pathology platform to assess diagnostic inter-observer reproducibility, enhance international collaboration and achieve diagnosis standardization.

  3. Secondary Objective - Identification of prognostic and predictive biomarkers

    Time frame: From enrollment at the end of 32 months

    Identify driver mutations, transcriptomes, and DNA methylation subclasses with morphological, immunophenotypic analyses and clinical data to provide a novel hybrid taxonomy and identify tissue prognostic and predictive biomarkers.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniela Massi Professor

CONTACT

[email protected]

3925536585 ext. +39

Dario Di Gangi Doctor

CONTACT

[email protected]

3925536585 ext. +39

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Collaborators

  • Fondazione IRCCS ISTITUTO NAZIONALE TUMORI
  • German Cancer Research Center
  • Hospital Clinic of Barcelona
  • Istanbul University
  • Maria Sklodowska-Curie National Research Institute of Oncology
  • Tubingen University Hospital
  • University Of Perugia

Registry information

Official study title

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)

Acronym: Mol-Mel

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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