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临床试验/NCT05004792
NCT05004792尚未招募不适用

Correlation Between Online Case-based Training of Pathologists in Dermoscopic Images and Diagnostic Accuracy in Histopathological Interpretation of Skin Lesions Suspicious of Melanoma

Herlev Hospital0 个研究点目标入组 258 人开始时间: 2026年8月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
258
主要终点
Diagnostic value

研究概览

简要总结

Pathologists provide the current gold standard in skin lesion diagnostics, most often primarily based on the interpretation of histological slides. Still, it has been suggested that pathologists' diagnostic accuracy and confidence could be improved if they gained access to additional clinical information and in-vivo clinical and dermoscopic images of melanocytic tumors. This study examines the effect of digital training for pathologists in interpreting dermoscopic and clinical skin tumor images.

This study aims to evaluate the impact of dermoscopy training on pathologists' assessment of melanoma-suspected skin lesions.

Data collection of DAHT cases: Department of plastic surgery, Herlev hospital, year 2020-2021,

DAHT platform: Made in 2021-2023 by Melatech,

Consensus agreement: Four dermatopathologists assess all DAHT cases, year 2023-2024

Enrollment of pathologists: Randomization and assessment DAHT cases, year 2026.

详细描述

Background Several publications suggest that the increasing melanoma incidence may partly be caused by histopathological overdiagnosis (Glasziou) and that the consequences of missing a melanoma may be one reason for this (Titus, L. J.). Pathologists provide the current gold standard in skin lesion diagnostics (Elmore 2017), primarily based on the interpretation of histological slides. Still, it has been suggested that pathologists' diagnostic accuracy and confidence could be improved if they gained access to additional clinical information and in vivo clinical and dermoscopic images of melanocytic tumors (Scolyer, Elder). The inter-rater reliability is significantly enhanced when pathologists are provided with dermoscopic and clinical images of the lesion during histopathological interpretation (Bauer, J.). This effect is especially pronounced among expert dermatopathologists who are proficient at evaluating dermoscopic images (Ferrara). However, interpreting dermoscopic images is challenging, and mastery typically requires several years of clinical experience (Ternov). Chevolet et al. reported in 2015 a significant difference in the interpretation of dermoscopic images between novices and clinicians with former dermoscopy training (Chevolet). The learning journey can be significantly shortened if the trainee receives comprehensive training in pattern recognition for dermoscopy and clinical images with immediate, accurate, and individualized feedback and access to a library with a large selection of skin lesion cases (Ericsson, Nervil). Recent studies in Denmark have shown that General Practitioners can increase their diagnostic accuracy by up to 10,5% by using a Large-scale Interactive Image Repository (LIIR) app for a few hours (Nervil). This method has yet to be tested on pathologists, which is what we indeed intend to do in this project.

Previous studies have focused only on melanocytic lesions (Elmore, Elder, Piepkorn, Ferrara). Still, most pathologists will receive both melanocytic and pigmented non-melanocytic lesions (seborrheic keratoses, dermatofibromas, etc.) clinically suspected of being melanoma. The current practice in preparing histological specimens involves creating standardized sections based on the clinician's assessment of the diagnosis and the size of the skin lesion. However, there is often no consideration of potentially suspicious areas within the skin lesion, and standard sectioning, staining, and subsequent evaluation may not occur in the most clinically suspicious areas. Previous studies have highlighted the importance of clinical information for accurate assessment of skin lesions, particularly melanocytic lesions (Scolyer), yet standardized clinical information for histopathological examination has not been systematically implemented in Denmark, likely due to a lack of technology enabling easy information sharing across medical specialties and healthcare sectors. Improving pathologists' diagnostic accuracy is crucial to ensuring patients receive the correct treatment. Dermoscopic images and training in their interpretation could be the future of histopathological skin lesion training.

Hypothesis Digital training in dermoscopy and clinical image interpretation improves diagnostic accuracy, confidence, and ease of skin lesion assessment among pathologists compared to those without such training.

Aim This study aims to evaluate the impact of dermoscopy training on pathologists' assessment of melanoma-suspected skin lesions.

Method The DAHT project includes an unfiltered selection of 203 clinically melanoma-suspect skin lesions excised at a specialized surgical department and consists of dermoscopic and clinical images, along with clinical information about the patients and skin lesions; this material is referred to as "DAHT cases". These cases will be assessed by the participating pathologists in a randomized order, and both individual and group performance will be analyzed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Participating Pathologists are either given access to a learning intervention called DermLoop Learn for a short period or not given access to any learning intervention. During the trial, both groups interpret histopathological skin lesions with access to clinical information, an overview picture, and a dermoscopic picture of the lesion.

入排标准

性别
All
接受健康志愿者

入选标准

  • Pathologists are required to evaluate melanocytic lesions routinely
  • Doctors must be registered authorized health personnel
  • Access to a smartphone/tablet/computer with internet

排除标准

  • - Assessment of less than 30 DAHT cases

研究组 & 干预措施

Control group

No Intervention

No access to DermLoop Learn

Intervention

Active Comparator

Access to DermLoop Learn IT platform

干预措施: DermLoop Learn (Other)

结局指标

主要结局

Diagnostic value

时间窗: 1 month

Diagnostic accuracy according to specific diagnoses and sensitivity and specificity according to correct classification of malignant vs. benign lesions

次要结局

  • MPATH-Dx specificity(1 month)
  • MPATH-Dx sensitivity(1 month)
  • Perceived diagnostic difficulty(1 month)
  • use of clinical information(1 month)
  • Needs for stains(1 month)
  • time/case(1 month)
  • Self-rated diagnostic confidence(1 month)
  • training time vs time spent/DAHT case(1 month)
  • Inter-rater reliability(1 month)
  • Dermoscopy test results(1 month)
  • Second opinion(1 month)
  • Average time spent on each image(1 month)
  • Needs for tests(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Louisa Bønløkke Nervil

Medical doctor

Herlev Hospital

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