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

NCT06602648 | Recruiting

• 1 other identifier: 24680_bio
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melanoma of Skin

Keywords

Melanoma; Pediatric; Childrens; Adolescents; Young adults

Outcome Measures

Primary Outcomes (2)

• Primary objective - Hybrid taxonomy

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

  From enrollment at the end of 32 months

• Primay objective - Histopathological and molecular features of pediatric melanoma

  Assess the histopathological and molecular features of pediatric melanomas.

  From enrollment at the end of 32 months

Secondary Outcomes (3)

• Secondary Objective - Identification of biomarkers

  From enrollment at the end of 32 months

• Secondary Objective - pan-European digital pathology platform

  From enrollment at the end of 32 months

• Secondary Objective - Identification of prognostic and predictive biomarkers

  From enrollment at the end of 32 months

Study Arms (1)

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.

Eligibility Criteria

• Age: Up to 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will focus on CAYA (\< 30 y.o) patients with histologically confirmed melanoma or intermediate/ambiguous melanocytic neoplasm (i.e.,melanocytomas, SAMPUS, IAMPUS and MELTUMP according to WHO classification).The population include patients of both genders.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

University of Florence

Florence, Italy, 50139, Italy

RECRUITING

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 30785015 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• MELCAYA official website

Biospecimen

Retention: SAMPLES WITH DNA

Formalin fixed and paraffin embedded (FFPE) samples of melanoma collected from the patient during routine surgery.

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Massi Daniela

  University of Florence (UNIFI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela Massi Professor

CONTACT

3925536585; daniela.massi@unifi.it

Dario Di Gangi Doctor

CONTACT

3925536585; dario.digangi@unifi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: April 17, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Up to 32 months from enrollment
• Access Criteria: The data will be managed by the main investigator of the study: Prof Daniela Massi, according to the recent European regulations in force of the GDPR and the Provision containing the requirements relating to the processing of particular categories of data, pursuant to art. 21, paragraph 1 of Legislative Decree 10 August 2018, n. 101 (GU no. 176 of 29 July 2019). Other collaborators can only access histopathological and clinical data of the patients.

Locations

IT (1)