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RecruitingNCT06994208MELA_2025Updated Dec 19, 2025

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

An observational study in Melanoma of Skin, sponsored by Ente Ospedaliero Ospedali Galliera. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2025-12-19.

Sponsored by Ente Ospedaliero Ospedali Galliera · Observational

From the registry’s dates

  • Started Dec 2025; still recruiting 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
18 Years to 39 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Melanoma of Skin

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03

In context

Melanoma

3,370 studies on the registry are indexed under Melanoma; 578 are open to participants now.

This study's planned enrollment of 25 is below the median of 187 across 488 observational studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

Ente Ospedaliero Ospedali Galliera is the lead sponsor of 19 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. written
  2. age > 18 years and \< 40 years
  3. diagnosis of cutaneous melanoma even non-primary

Exclusion criteria

Exclusion Criteria:

-

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • ARM 1

    Patients with melanoma diagnosis aged between 18 and 39 years.

06

What researchers measure

Primary outcomes

  1. Melanoma prevalence

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

    Time frame: 3 years

Secondary outcomes

  1. Risk factor

    Identification of risk factors associated with melanoma in young people.

    Time frame: 3 years

  2. Melanoma phenotype

    Description of the main phenotypic of melanoma in this age group.

    Time frame: 3 years

  3. Histopathological feature

    Evaluation of the likely association between clinical and histopathological features of melanoma in young people.

    Time frame: 3 years

  4. Mutational status

    Identification of the presence of B-RAF mutations

    Time frame: 3 years

  5. Dermoscopy of melanoma

    Description of the main dermoscopic characteristics of melanoma in this age group.

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Sep 2027, 20 months after the start.

Of 177 non-industry observational studies under Melanoma, half reached primary completion within 178 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 320. This study's planned 20 months is below that.

Counting every sponsor, half of 236 studies reached it within 71 months; a quarter within 35 and three quarters within 223.

How these figures are worked out, and which studies are left out of them.

Registered
May 20, 2025
First posted
May 29, 2025
StartActual
Dec 2, 2025
Primary completionEst.
Sep 1, 2027
CompletionEst.
Aug 31, 2028
Last update
Dec 19, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06994208
Lead sponsor
Ente Ospedaliero Ospedali Galliera
Responsible party
Sanja Javor (Medical doctor, Ente Ospedaliero Ospedali Galliera) — Principal investigator
First posted
May 29, 2025
Start date
Dec 2, 2025
Primary completion
Sep 1, 2027 (estimated)
Completion
Aug 31, 2028 (estimated)
Last update
Dec 19, 2025

Study contacts

Sanja Javor, MD
Contact
sanja.javor@galliera.it
+390105634271
Davide Corradengo
Contact
davide.corradengo@galliera.it
+39010.563.4580
Sanja Javor
principal investigator · Ente Ospedaliero Ospedali Galliera

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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