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临床试验/NCT05712551
NCT05712551已完成不适用

Diagnostic Agreement Among Expert Dermatopathologists on Skin Lesions Clinically Suspicious of Melanoma

Herlev Hospital2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2023年4月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4
试验地点
2
主要终点
Gold standard diagnosis by using a Delphi-like process

研究概览

简要总结

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. The primary outcome of the upcoming DAHT RCT (Dermoscopy Augmented Histology Trial, a randomized controlled trial) is the diagnostic value (accuracy, sensitivity, and specificity) for the intervention and control group. For this purpose, we need an expert agreeable MPATH-Dx classification and diagnosis for all DAHT cases. The DAHT consensus trial strives to establish this gold standard through a four-phased Delphi-like process.

Aim: To establish an expert agreeable MPTAH-Dx classification and diagnosis for all DAHT cases.

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

详细描述

Background Several publications suggest that the increasing melanoma incidence may partly be caused by histopathological overdiagnosis (Glasziou, 2020). Pathologists provide the current gold standard in skin lesion diagnostics (Elmore, 2017), 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 (Scolyer, 2019) (Elder, 2018). This could help the pathologist generate a complete image of the lesion. However, interpreting clinical and dermoscopic images is challenging, and mastery typically requires several years of clinical experience (Ternov 2021). This learning journey can be significantly shortened if the trainee receives comprehensive training in pattern recognition for dermoscopy and clinical images, including immediate, accurate, and individualized feedback and access to a library with a large selection of skin lesion cases (Ericsson, 2015).

This study examines the effect of digital training for pathologists in interpreting dermoscopic and clinical skin tumor images.

Former studies have only focused on melanocytic lesions. Still, most pathologists will receive both melanocytic and pigmented non-melanocytic lesions (seborrheic keratoses, dermatofibromas, etc.) due to clinical suspicion of melanoma. This study includes an un-filtered selection of 211 clinically melanoma-suspect skin lesions excised at a specialized surgical department; this material is named the DAHT cases.

The primary outcome of the upcoming DAHT RCT (Dermoscopy Augmented Histology Trial, a randomized controlled trial) is the diagnostic value (accuracy, sensitivity, and specificity) for the intervention and control group. For this purpose, we need an MPATH-Dx classification and diagnosis for all DAHT cases agreed upon by experts in the field. The DAHT consensus agreement trial strives to establish this through a four-phased Delphi-like process.

Aim: To establish an expert agreeable MPTAH-Dx classification and diagnosis for all DAHT cases.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • well-acknowledged expert in dermatopathology
  • Invited by our group

排除标准

  • Do not assess all DAHT cases

结局指标

主要结局

Gold standard diagnosis by using a Delphi-like process

时间窗: 3 months

Diagnostic agreement among participating experts in all DAHT cases with individual assessments and, later on, a discussion about ambiguous cases.

次要结局

未报告次要终点

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

研究点 (2)

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