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临床试验/NCT06908720
NCT06908720尚未招募不适用

A Prospective Observational Study for Defining the Role of Optical Super-high Magnification Dermoscopy in the Diagnosis of Skin Tumors

IRCCS Ospedale San Raffaele0 个研究点目标入组 1,000 人开始时间: 2025年4月最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,000
主要终点
Evaluate the diagnostic accuracy and clinical utility of super-high magnification dermoscopy in the detection and differentiation of skin tumors

研究概览

简要总结

This is a prospective study aimed at evaluating the diagnostic accuracy (compared to histopathological diagnosis) and clinical utility of optical super-high magnification dermoscopy (OSHMD) in detecting and differentiating skin tumors, including both benign and malignant lesions, particularly in nevi/melanoma and basal cell carcinoma, in patients with suspicious lesions at a magnification of 20x. Additionally, the characteristics of skin lesions will be analyzed using OSHMD, and their distribution in skin tumors will be assessed. The agreement between the examiners' evaluations and the concordance between dermoscopic diagnoses at 20x and 400x compared to histopathological diagnosis will also be examined. The hypothesis is that OSHMD could assist in identifying malignancy features, thus improving the diagnostic accuracy of skin tumors and potentially leading to earlier and more precise detection of neoplasms

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients who will come to our attention for skin cancer screening with dermoscopy, willing to partecipate to the study

排除标准

  • patients aged under 18 year old
  • patients unable to understand and signed the onformed consent

结局指标

主要结局

Evaluate the diagnostic accuracy and clinical utility of super-high magnification dermoscopy in the detection and differentiation of skin tumors

时间窗: from the enrollment to the reaching of 1000 patients or up to 156 weeks

Accuracy (sensibility and specificity) of dermoscopy 400x for detecting skin tumors (vs histopathological diagnosis)

次要结局

未报告次要终点

研究者

发起方
IRCCS Ospedale San Raffaele
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guida Stefania

Dr. Stefania Guida is a medical doctor, Specialist in Dermatology and Venereology, and holds a PhD in "Clinical and Experimental Medicine." She currently holds the position of researcher at the Clinical Dermatology Unit at HSR

IRCCS Ospedale San Raffaele

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