Melanoma of SkinMELA_2025NCT06994208
Characteristics of Adult Patients With Melanoma Diagnosis <40 Years Age.
An observational study of Melanoma of Skin, run by Ente Ospedaliero Ospedali Galliera at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Melanoma of Skin
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 2 Dec 2025to 31 Aug 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- 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.
Who may be able to join
- written informed consent
- age > 18 years and < 40 years
- diagnosis of cutaneous melanoma even non-primary
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
E.O. Ospedali Galliera
Genoa, Liguria, 16128
Sanja Javor, MD, +390105634278, sanja.javor@galliera.it
About this study
Official title: Demographic, Clinical, Dermoscopic, Phenotypic and Genetic Characteristics of Adult Patients With Melanoma Diagnosis <40 Years Age. A Prospective, Monocentric Observational Study
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
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ARM 1 | Patients with melanoma diagnosis aged between 18 and 39 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melanoma prevalence
Estimated prevalence of melanoma in a cohort group of patients aged 18 - 39 years
Measured: 3 years
Secondary outcomes (5)
Risk factor
Identification of risk factors associated with melanoma in young people.
Measured: 3 years
Melanoma phenotype
Description of the main phenotypic of melanoma in this age group.
Measured: 3 years
Histopathological feature
Evaluation of the likely association between clinical and histopathological features of melanoma in young people.
Measured: 3 years
Mutational status
Identification of the presence of B-RAF mutations
Measured: 3 years
Dermoscopy of melanoma
Description of the main dermoscopic characteristics of melanoma in this age group.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start2 Dec 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma of SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ente Ospedaliero Ospedali Galliera
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanja Javor, Ente Ospedaliero Ospedali Galliera
- Investigators
- Sanja Javor, Principal investigator, Ente Ospedaliero Ospedali Galliera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994208
- Sponsor's protocol ID
- Melanoma_2025
- Acronym
- MELA_2025
- Status last verified
- Dec 2025
- First submitted
- 20 May 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demographic, Clinical, Dermoscopic, Phenotypic and Genetic Characteristics of Adult Patients With Melanoma Diagnosis <40 Years Age. A Prospective, Monocentric Observational Study
- ClinicalTrials.gov ID
- NCT06994208
- Acronym / sponsor ID
- MELA_2025 / Melanoma_2025
- Conditions
- Melanoma of Skin
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Ente Ospedaliero Ospedali GallieraUniversity, hospital or other
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARM 1 | – | –Patients with melanoma diagnosis aged between 18 and 39 years. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- written informed consent
- age > 18 years and < 40 years
- diagnosis of cutaneous melanoma even non-primary
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Melanoma prevalence
Time frame: 3 years
Estimated prevalence of melanoma in a cohort group of patients aged 18 - 39 years
5 secondary outcomes
Risk factor
Time frame: 3 years
Melanoma phenotype
Time frame: 3 years
Histopathological feature
Time frame: 3 years
Mutational status
Time frame: 3 years
Dermoscopy of melanoma
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sanja Javor principal investigator
Ente Ospedaliero Ospedali Galliera
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma of Skin, run by Ente Ospedaliero Ospedali Galliera at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanja Javor, MD (+390105634271, sanja.javor@galliera.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Melanoma prevalence (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.