Characteristics of Adult Patients With Melanoma Diagnosis... | NCT06994208

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

NCT06994208

Sponsor

Ente Ospedaliero Ospedali Galliera

Status

Recruiting

Last Update Posted

Dec 19, 2025Actual

Enrollment

25Estimated

Phase

Not provided

Conditions

Melanoma of Skin

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2, 2025Actual

Primary Completion Date

Sep 1, 2027Estimated

Completion Date

Aug 31, 2028Estimated

First Submitted Date

May 20, 2025

First Submission Date that Met QC Criteria

May 20, 2025

First Posted Date

May 29, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2025

Last Update Posted Date

Dec 19, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Label	Type	Description	Intervention Names
ARM 1		Patients with melanoma diagnosis aged between 18 and 39 years.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Melanoma prevalence	Estimated prevalence of melanoma in a cohort group of patients aged 18 - 39 years	3 years

Secondary Outcomes

Measure	Description	Time Frame
Risk factor	Identification of risk factors associated with melanoma in young people.	3 years
Melanoma phenotype	Description of the main phenotypic of melanoma in this age group.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

39 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sanja Javor, MD	Contact	+390105634271		sanja.javor@galliera.it
Davide Corradengo	Contact	+39010.563.4580		davide.corradengo@galliera.it

Overall Officials

Name	Affiliation	Role
Sanja Javor	Ente Ospedaliero Ospedali Galliera	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
E.O. Ospedali Galliera	Recruiting	Genoa	Liguria	16128	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

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Browse Branches

Not provided