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CompletedNCT05463510Updated Jul 19, 2022

Dermoscopic Monitoring of Pediatric Melanocytic Nevi Regarding Pattern and Diameter Changes

An observational study in Nevus, Pigmented, sponsored by Istanbul Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2022-07-19.

Sponsored by Istanbul Training and Research Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
50
Ages
1 Year to 18 Years
Sex
All
01

Study 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. 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)

02

Conditions studied

  • Nevus, Pigmented
03

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Sampling method
Probability sample

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.

Inclusion criteria

  • Subjects \<18 years of age
  • Subjects who have dermoscopic diagnosis of melanocytic nevus
  • Subjects who had dermoscopic follow up for at least 3 months

Exclusion criteria

Exclusion Criteria:

  • Subjects >18 years of age
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • Pediatric melanocytic nevus

    50 patients and 301 pediatric nevi were evaluated

    Diagnostic Test: Videodermoscopy

Interventions

  • Diagnostic testVideodermoscopy

    Patients who had records for at least twice with videodermoscopy every 3 months were included.

05

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 3-36 months

  2. Pediatric nevi pattern change

    Nevus pattern change at 3/12/36th months (pattern is categorized as globular/reticular/homogenous/fibrillar/parallel furrow or combinations)

    Time frame: 3-36 months

  3. 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

    Time frame: 3-36 months

06

Study locations

1 site
  • Istanbul Teaching and Research Hospital
    Istanbul, Istanbul/Fatih 34098, Turkey
07

References and documents

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 29186245 ↗
  • Zalaudek 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 21690528 ↗
  • Fortina 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 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT05463510
Lead sponsor
Istanbul Training and Research Hospital
Responsible party
Ayse Esra Koku Aksu (Head of the Dermatology Department, MD, Istanbul Training and Research Hospital) — Principal investigator
First posted
Jul 19, 2022
Start date
Mar 25, 2022
Primary completion
Apr 25, 2022
Completion
Apr 25, 2022
Last update
Jul 19, 2022

Study contacts

Ayse Esra Koku Aksu, MD
principal investigator · Istanbul Teaching and Research Hospital

Oversight

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

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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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