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

Study Purpose

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&#39;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&#39;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&#39;s full recovery in the shortest possible time.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	N/A - 30 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06602648
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Florence
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Massi Daniela
Principal Investigator Affiliation	University of Florence (UNIFI)
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma of Skin
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

: 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.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

University of Florence, Florence, Italy

Status

Recruiting

Address

University of Florence

Florence, , 50139

Site Contact

Daniela Massi Professor

[email protected]

05579490982 #+39

Clinical Trial Finder