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Dermoscopic Monitoring of Pediatric Melanocytic Nevi Regarding Pattern and Diameter Changes

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ClinicalTrials.gov Identifier: NCT05463510
Recruitment Status : Completed
First Posted : July 19, 2022
Last Update Posted : July 19, 2022
Sponsor:
Information provided by (Responsible Party):
Ayse Esra Koku Aksu, Istanbul Training and Research Hospital

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.

Condition or disease Intervention/treatment
Nevus, Pigmented Diagnostic Test: Videodermoscopy

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)

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Dermoscopic Monitoring of Pediatric Melanocytic Nevi Regarding Pattern and Diameter Changes
Actual Study Start Date : March 25, 2022
Actual Primary Completion Date : April 25, 2022
Actual Study Completion Date : April 25, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Birthmarks Moles

Group/Cohort Intervention/treatment
Pediatric melanocytic nevus
50 patients and 301 pediatric nevi were evaluated
Diagnostic Test: Videodermoscopy
Patients who had records for at least twice with videodermoscopy every 3 months were included.




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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



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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05463510


Locations
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Turkey
Istanbul Teaching and Research Hospital
Istanbul, Istanbul/Fatih, Turkey, 34098
Sponsors and Collaborators
Istanbul Training and Research Hospital
Investigators
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Principal Investigator: Ayse Esra Koku Aksu, MD Istanbul Teaching and Research Hospital
Publications of Results:
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Responsible Party: Ayse Esra Koku Aksu, Head of the Dermatology Department, MD, Istanbul Training and Research Hospital
ClinicalTrials.gov Identifier: NCT05463510    
Other Study ID Numbers: Karar no:108 25.03.2022
First Posted: July 19, 2022    Key Record Dates
Last Update Posted: July 19, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nevus
Nevus, Pigmented
Nevi and Melanomas
Neoplasms by Histologic Type
Neoplasms