Characteristics of Adult Patients With Melanoma Diagnosis <40 Years Age.

NCT06994208 | Recruiting DMC

• 1 other identifier: Melanoma_2025
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to analyse a local cohort of patients aged 18-39 years with melanoma diagnosis in order to determine the prevalence of the disease in this age group. Secondary objectives are the following:

• To identify risk factors associated with melanoma in young people.
• To characterise the phenotype and dermoscopic features of melanoma in patients aged 18-39 years.
• To analyse the relationship between the clinical and histopathological features of melanoma in young people.
• To identify the mutational status of B-RAF in the sample of patients analysed.

Conditions

Melanoma of Skin

Outcome Measures

Primary Outcomes (1)

• Melanoma prevalence

  Estimated prevalence of melanoma in a cohort group of patients aged 18 - 39 years

  3 years

Secondary Outcomes (5)

• Risk factor

  3 years

• Melanoma phenotype

  3 years

• Histopathological feature

  3 years

• Mutational status

  3 years

• Dermoscopy of melanoma

  3 years

Study Arms (1)

ARM 1

Patients with melanoma diagnosis aged between 18 and 39 years.

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Since there are no epidemiological data about the prevalence of melanoma in subjects aged 18-39 years, there are very few data available on risk factors in this age group and the impact of the disease. The present study, therefore, will enroll about 25 patients who will attend the Dermatology Unit and who have a histological diagnosis of cutaneous melanoma in a period of 24 months of observation.

You may qualify if:

• written informed consent
• age \> 18 years and \< 40 years
• diagnosis of cutaneous melanoma even non-primary

Sponsors & Collaborators

• Ente Ospedaliero Ospedali Galliera: lead

Study Sites (1)

E.O. Ospedali Galliera

Genoa, Liguria, 16128, Italy

RECRUITING

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

• Sanja Javor

  Ente Ospedaliero Ospedali Galliera

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanja Javor, MD

CONTACT

+390105634271; sanja.javor@galliera.it

Davide Corradengo

CONTACT

+39010.563.4580; davide.corradengo@galliera.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 29, 2025
• Study Start: December 2, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)