NCT05463510

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

1 month

First QC Date

July 8, 2022

Last Update Submit

July 18, 2022

Conditions

Nevus, Pigmented

Outcome Measures

Primary Outcomes (3)

  • 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)

    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)

    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

    3-36 months

Study Arms (1)

Pediatric melanocytic nevus

50 patients and 301 pediatric nevi were evaluated

Diagnostic Test: Videodermoscopy

Interventions

VideodermoscopyDIAGNOSTIC_TEST

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

Pediatric melanocytic nevus

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Subjects \>18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Teaching and Research Hospital

Istanbul, Istanbul/Fatih, 34098, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 29186245RESULT

  • 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.

    PMID: 21690528RESULT

  • 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.

    PMID: 22367216RESULT

MeSH Terms

Conditions

Nevus, Pigmented

Condition Hierarchy (Ancestors)

NevusNevi and MelanomasNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Ayse Esra Koku Aksu, MD

    Istanbul Teaching and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Dermatology Department, MD

Study Record Dates

First Submitted

July 8, 2022

First Posted

July 19, 2022

Study Start

March 25, 2022

Primary Completion

April 25, 2022

Study Completion

April 25, 2022

Last Updated

July 19, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)