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临床试验/NCT01540695
NCT01540695已完成不适用

Does Cryofixation of Skin Specimens Affect Quality of Subsequent Formalin Fixed Paraffin Embedded H&E Histology

Abramson Cancer Center at Penn Medicine1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
180
试验地点
1
主要终点
Number of Adverse Events

研究概览

简要总结

This prospective study of 60 slides of basal and squamous cell carcinomas of the skin aims to determine whether:

  1. The process of cryofixation prior to generating formalin fixed paraffin embedded (FFPE) H&E sections alters the histology in skin tumor specimens.
  2. Which specific histologic parameters are altered between previously cryofixed versus routine FFPE sections. Histologic observations will be recorded by two dermatopathologists and two Mohs surgeons and statistically analyzed.

详细描述

Generating formalin fixed paraffin embedded (FFPE) hematoxylin and eosin (H&E) stained permanent sections from previously cryofixed tissue is a common practice used to confirm diagnosis of frozen section histology. In dermatology, this practice can be used to examine Mohs layers and its debulk as well as routine nonmelanoma skin cancer (NMSC) biopsies after initial histologic diagnosis with frozen sections. Even though freezing tissue can introduce histologic artifacts, there have been no studies documenting whether this occurs specifically in cryofixed tissues that are subsequently thawed for permanent FFPE H&E histology. The purpose of our study is to determine whether the freeze-thaw process used to generate permanent sections after cryofixation introduces significantly detectable histologic differences compared to permanent sections that were not previously cryofixed. Thirty debulk specimens of basal cell and squamous cell carcinomas will be prospectively collected. Each specimen will be split so that half is processed as cryofixed permanents and the other half as noncryofixed permanents. The investigator will show each slide in random order to a group of four blinded participants (two dermatopathologists and two Mohs surgeons). Each participant must first rate the overall quality of histology. Then, each participant will rate each slide on the quality of cellular morphology, nuclear morphology, color and contrast of stains, intactness of specimen, and other miscellaneous artifacts. These data will then be analyzed for statistical significance.

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

入选标准

  • Adult patients (age 18 or over) with a biopsy proven routine basal cell or squamous cell carcinoma of the skin who are scheduled for treatment with the Mohs procedure by Dr. Christopher Miller at the University of Pennsylvania's Division of Dermatologic Surgery will be included. Both female and male patients will be included.

排除标准

  • Patients with basal cell or squamous cell carcinomas of more complex histopathology will be excluded from the study. Complex histopathology of a tumor is defined as features with aggressive, moderately to poorly differentiated, or unusual histopathology.

结局指标

主要结局

Number of Adverse Events

时间窗: October 2016 to March 2018

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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