Nevus, PigmentedNCT05463510
Dermoscopic Monitoring of Pediatric Melanocytic Nevi Regarding Pattern and Diameter Changes
An observational study of Nevus, Pigmented, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Childhood and adolescence are a dynamic process in terms of nevogenesis, and the development and growth of new melanocytic nevus is frequently observed. Melanomas, although rare, can also be seen in the pediatric age group. Therefore, nevus monitoring with videodermoscopy may be necessary in the pediatric age group. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Nevus, Pigmented
- What is being tested?
- Videodermoscopy
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2022to 25 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 year to 18 years
- All sexes
- Child, Adult
Study population: Patients who applied to the Dermatology Clinic of Istanbul Training and Research Hospital between January 2008 and January 2022, were diagnosed with pediatric melanocytic nevus clinically and dermoscopically were included. Patients who had records for at least twice with videodermoscopy every 3 months were included. In the study, 301 pediatric melanocytic nevi belonging to 50 patients were evaluated.
Who may be able to join
- Subjects <18 years of age
- Subjects who have dermoscopic diagnosis of melanocytic nevus
- Subjects who had dermoscopic follow up for at least 3 months
Who cannot join
- Subjects >18 years of age
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Teaching and Research Hospital
Istanbul, Istanbul/Fatih, 34098
About this study
Childhood and adolescence are a dynamic process in terms of nevogenesis, and the development and growth of new melanocytic nevus is frequently observed. Melanomas, although rare, can also be seen in the pediatric age group. Therefore, nevus monitoring with videodermoscopy may be necessary in the pediatric age group. Aim of our study is to show the dynamic pattern and diameter modifications in pediatric nevi.
Read the detailed description
Aim of our study is to show the dynamic pattern and diameter modifications in pediatric nevi. Patients who applied to the Dermatology Clinic of Istanbul Training and Research Hospital between January 2008 and January 2022, were diagnosed with pediatric melanocytic nevus clinically and dermoscopically were included. Patients who had records for at least twice with videodermoscopy every 3 months were included. In the study, 301 pediatric melanocytic nevi belonging to 50 patients were evaluated.
The following characteristics were recorded in a database specifically designed for the study:Demographic findings of the patients, nevus localization, nevus pattern (baseline and follow-up), nevus diameter (base line and follow-up at 3/12/36th months), histopathological results of nevi that underwent total excision were recorded. The change in nevus diameter during follow-up was measured in millimeters based on the longest axis. Presence of peripheral globules, outcome of peripheral globules, characteristics of peripheral globules were recorded. Characteristics of peripheral globules were evaluated according to being around the entire lesion (circumferential) versus focally presence, typical (uniform shape and colors) and being regular (single rim of globules or multiple rim of globules)
- Conditions
- Nevus, Pigmented
- Being tested
- Videodermoscopy
- Medical subject headings
- Nevus, Pigmented
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideodermoscopyDiagnostic test
Patients who had records for at least twice with videodermoscopy every 3 months were included.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric melanocytic nevus | 50 patients and 301 pediatric nevi were evaluated Receives: Diagnostic Test: Videodermoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric nevi diameter change in millimeters
1.Nevus diameter change at 3/12/36th months (measurement of longest axis of nevus as millimeters with videodermoscopy)
Measured: 3-36 months
Pediatric nevi pattern change
Nevus pattern change at 3/12/36th months (pattern is categorized as globular/reticular/homogenous/fibrillar/parallel furrow or combinations)
Measured: 3-36 months
Presence of peripheral globules
Peripheral globules will be recorded if present and will be categorized as (increased, decreased or no change) at the 3/12/36th months
Measured: 3-36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start25 Mar 2022
- Primary completion25 Apr 2022
- Study completion25 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nevus, PigmentedStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ayse Esra Koku Aksu, Istanbul Training and Research Hospital
- Investigators
- Ayse Esra Koku Aksu, MD, Principal investigator, Istanbul Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463510
- Sponsor's protocol ID
- Karar no:108 25.03.2022
- Status last verified
- Jul 2022
- First submitted
- 8 Jul 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Piazza CD, Yamada S, Marcassi AP, Maciel MG, Seize MP, Cestari SCP. Dermoscopic patterns of melanocytic nevi in children and adolescents: a cross-sectional study. An Bras Dermatol. 2017 May-Jun;92(3):340-344. doi: 10.1590/abd1806-4841.20175209.
PubMed 29186245Zalaudek I, Schmid K, Marghoob AA, Scope A, Manzo M, Moscarella E, Malvehy J, Puig S, Pellacani G, Thomas L, Catricala C, Argenziano G. Frequency of dermoscopic nevus subtypes by age and body site: a cross-sectional study. Arch Dermatol. 2011 Jun;147(6):663-70. doi: 10.1001/archdermatol.2011.149.
PubMed 21690528Fortina AB, Zattra E, Bernardini B, Alaibac M, Peserico A. Dermoscopic changes in melanocytic naevi in children during digital follow-up. Acta Derm Venereol. 2012 Jul;92(4):427-9. doi: 10.2340/00015555-1306.
PubMed 22367216
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dermoscopic Monitoring of Pediatric Melanocytic Nevi Regarding Pattern and Diameter Changes
- ClinicalTrials.gov ID
- NCT05463510
- Acronym / sponsor ID
- Karar no:108 25.03.2022
- Conditions
- Nevus, Pigmented
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 19 Jul 2022 (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.
Childhood and adolescence are a dynamic process in terms of nevogenesis, and the development and growth of new melanocytic nevus is frequently observed. Melanomas, although rare, can also be seen in the pediatric age group. Therefore, nevus monitoring with videodermoscopy may be necessary in the pediatric age group. Aim of our study is to show the dynamic pattern and diameter modifications in pediatric nevi.
Detailed description
Aim of our study is to show the dynamic pattern and diameter modifications in pediatric nevi. Patients who applied to the Dermatology Clinic of Istanbul Training and Research Hospital between January 2008 and January 2022, were diagnosed with pediatric melanocytic nevus clinically and dermoscopically were included. Patients who had records for at least twice with videodermoscopy every 3 months were included. In the study, 301 pediatric melanocytic nevi belonging to 50 patients were evaluated.
The following characteristics were recorded in a database specifically designed for the study:Demographic findings of the patients, nevus localization, nevus pattern (baseline and follow-up), nevus diameter (base line and follow-up at 3/12/36th months), histopathological results of nevi that underwent total excision were recorded. The change in nevus diameter during follow-up was measured in millimeters based on the longest axis. Presence of peripheral globules, outcome of peripheral globules, characteristics of peripheral globules were recorded. Characteristics of peripheral globules were evaluated according to being around the entire lesion (circumferential) versus focally presence, typical (uniform shape and colors) and being regular (single rim of globules or multiple rim of globules)
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric melanocytic nevus | – | Diagnostic Test: Videodermoscopy50 patients and 301 pediatric nevi were evaluated |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients who applied to the Dermatology Clinic of Istanbul Training and Research Hospital between January 2008 and January 2022, were diagnosed with pediatric melanocytic nevus clinically and dermoscopically were included. Patients who had records for at least twice with videodermoscopy every 3 months were included. In the study, 301 pediatric melanocytic nevi belonging to 50 patients were evaluated.
Key inclusion criteria (3 listed)
- Subjects <18 years of age
- Subjects who have dermoscopic diagnosis of melanocytic nevus
- Subjects who had dermoscopic follow up for at least 3 months
Key exclusion criteria (1 listed)
- Subjects >18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VideodermoscopyPatients who had records for at least twice with videodermoscopy every 3 months were included. | Diagnostic test | Pediatric melanocytic nevus |
Primary outcome
Pediatric nevi diameter change in millimeters
Time frame: 3-36 months
1.Nevus diameter change at 3/12/36th months (measurement of longest axis of nevus as millimeters with videodermoscopy)
Pediatric nevi pattern change
Time frame: 3-36 months
Nevus pattern change at 3/12/36th months (pattern is categorized as globular/reticular/homogenous/fibrillar/parallel furrow or combinations)
Presence of peripheral globules
Time frame: 3-36 months
Peripheral globules will be recorded if present and will be categorized as (increased, decreased or no change) at the 3/12/36th months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Results publication: PubMed 29186245Piazza CD, Yamada S, Marcassi AP, Maciel MG, Seize MP, Cestari SCP. Dermoscopic patterns of melanocytic nevi in children and adolescents: a cross-sectional study. An Bras Dermatol. 2017 May-Jun;92(3):340-344. doi: 10.1590/abd1806-4841.20175209.
- Results publication: PubMed 21690528Zalaudek I, Schmid K, Marghoob AA, Scope A, Manzo M, Moscarella E, Malvehy J, Puig S, Pellacani G, Thomas L, Catricala C, Argenziano G. Frequency of dermoscopic nevus subtypes by age and body site: a cross-sectional study. Arch Dermatol. 2011 Jun;147(6):663-70. doi: 10.1001/archdermatol.2011.149.
- Results publication: PubMed 22367216Fortina AB, Zattra E, Bernardini B, Alaibac M, Peserico A. Dermoscopic changes in melanocytic naevi in children during digital follow-up. Acta Derm Venereol. 2012 Jul;92(4):427-9. doi: 10.2340/00015555-1306.
- 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. This study is not recruiting at the moment.
Ayse Esra Koku Aksu, MD principal investigator
Istanbul Teaching and Research Hospital
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 Nevus, Pigmented, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 19 Jul 2022. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric nevi diameter change in millimeters (time frame: 3-36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05463510, which also lists 3 linked publications.
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 Jul 2022.