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临床试验/NCT05463510
NCT05463510已完成不适用

Dermoscopic Monitoring of Pediatric Melanocytic Nevi Regarding Pattern and Diameter Changes

Istanbul Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Pediatric nevi diameter change in millimeters

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Subjects >18 years of age

结局指标

主要结局

Pediatric nevi diameter change in millimeters

时间窗: 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

时间窗: 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

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Istanbul Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ayse Esra Koku Aksu

Head of the Dermatology Department, MD

Istanbul Training and Research Hospital

研究点 (1)

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