Clinical trial NCT05463510: Dermoscopic Monitoring of Pediatric Melanocytic Nevi Regarding Pattern and Diameter Changes
Official title: Dermoscopic Monitoring of Pediatric Melanocytic Nevi Regarding Pattern and Diameter Changes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nevus, Pigmented
Lead sponsor: Istanbul Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-07-19
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

Brief 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.

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)

Eligibility criteria: 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:

* Subjects \>18 years of age

Primary outcomes:
measure: Pediatric nevi diameter change in millimeters
timeFrame: 3-36 months
measure: Pediatric nevi pattern change
timeFrame: 3-36 months
measure: Presence of peripheral globules
timeFrame: 3-36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Teaching and Research Hospital
state: Istanbul/Fatih
Study officials:
affiliation: Istanbul Teaching and Research Hospital
name: Ayse Esra Koku Aksu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.