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临床试验/NCT06020612
NCT06020612已完成不适用

Desmoplasia in Cutaneous Squamous Cell Carcinoma: Inter Observer Agreement Between Dermatopathologists.

Maastricht University Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年7月1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
50
试验地点
1
主要终点
Interobserver agreement

研究概览

简要总结

According to the most recent guideline of the National Comprehensive Cancer Network (NCCN), desmoplasia is considered to be a very high risk factor for recurrence, metastasis and death in cutaneous squamous cell carcinoma (cSCC). The presence of desmoplasia is assessed by dermatopathologists during histological examination of cSCCs. However, the inter-observer agreement is between dermatopathologists in the assessment of desmoplasia is unclear. Studies on inter-observer variability in the assessment of differentiation grade in cSCCs showed that there is only a weak to moderate agreement among dermatopathologists in the assessment of differentiation grade (2-4). This study aims to investigate the interobserver agreement of desmoplasia between dermatopathologists. In this prospective study, 50 cSCCs will be assessed for desmoplasia by at least eight dermatopathologists using a predefined definition.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Histological coupes of patients with a cSCC between 2010 and 2018 (both cSCC with and without desmoplasia are included)
  • Treated at the Maastricht University Medical Center+ (MUMC+)in Maastricht for their cSCC
  • Of which the histology is available in the MUMC+

排除标准

  • 未提供

结局指标

主要结局

Interobserver agreement

时间窗: Through study completion, an average of 2 months

Interobserver agreement between dermatopathologists in the assessment of desmoplasia, expressed as percentages and Fleiss' kappa (Landis and Koch, see below) \<0 Poor agreement 0.0-0.20 Slight agreement 0.21-0.40 Fair agreement 0.41-0.60 Moderate agreement 0.61-0.80 Substantial agreement 0.81-1.00 Almost perfect agreement

次要结局

  • Definitions used(Before the histological assessment, at baseline.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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