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临床试验/NCT05089188
NCT05089188Unknown不适用

PRAME Immunohistochemistry as an Adjunct for Evaluating Ambiguous Melanocytic Proliferation

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2021年11月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
55
试验地点
1
主要终点
Immunomarkers

研究概览

简要总结

Skin melanoma is a common form of skin cancer. Its diagnosis is usually clinically suspected and then affirmed by histopathological examination.

In some cases, the histopathological analysis of these lesions is equivocal, and the malignant or benign nature of the proliferation is difficult to determine with certainty. In these cases, the use of expensive ancillary tests, which are hardly accessible and take a long time to set up (FISH - CGH-array), is usually required.

Anti-PRAME immunostaining, an inexpensive and readily available technic, has recently been described as highly sensitive and specific for diagnosing malignant melanocytic proliferations. Knowledge on its utility for evaluating ambiguous melanocytic neoplasms remains limited.

Our study aims to improve the current body of knowledge on the utility of PRAME immunohistochemistry for evaluating challenging samples of melanocytic proliferation. The secondary objective is to determine the PRAME immunoreactivity profile for each histological subtype of melanocytic proliferations (spitzoid tumors, cellular blue nevi, dysplastic nevi ...)

研究设计

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

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 patient at the time of diagnosis (> = 18 years).
  • histopathological diagnosis of "ambiguous melanocytic proliferation" or "atypical melanocytic proliferation" made between January 2016 and December
  • Histological slides archived in the "CRB" biobank available
  • Formalin-fixed paraffin-embedded tissue block archived in the "CRB" biobank available
  • Informed patient

排除标准

  • Patient who has expressed opposition to participating in the study.

结局指标

主要结局

Immunomarkers

时间窗: 1 month

Correlation of melanocytic lesions' histopathological diagnosis concerning benignity or malignancy with anti-PRAME immunohistochemical expression profile

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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