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临床试验/NCT05581342
NCT05581342已完成不适用

Optical Coherence Tomography for Diagnosing Recurrent Basal Cell Carcinoma After Non-invasive Treatment

Maastricht University Medical Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年1月15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
100
试验地点
2
主要终点
The added value of OCT for the detection of recurrent BCC

研究概览

简要总结

Superficial basal cell carcinoma (sBCC) can be treated non-invasively, but follow-up is necessary because lesions can reoccur. This study aims to evaluate the additional value of optical coherence tomography (OCT) for the detection of recurrent BCC lesions, that may remain unrecognized by clinical and dermoscopic examination (CDE). This study compared the diagnostic accuracy of CDE and CDE combined with OCT for detection of recurrent basal cell carcinoma (BCC) after non-invasive treatment of sBCC.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

盲法说明

The OCT assessor was blinded to the histopathological examination of the independent dermatopathologist, whereas the dermatopathologist was blinded to the OCT assessment.

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

  • Non-invasively treated sBCC patients
  • 18+ years of age

排除标准

  • Unable to sign informed consent

结局指标

主要结局

The added value of OCT for the detection of recurrent BCC

时间窗: 1- 56 months post treatment

The investigators evaluated the difference in sensitivity between CDE and CDE + OCT

次要结局

  • The number of false-positive OCT test results(1- 56 months post treatment)
  • Subtyping recurrent BCC by OCT(1- 56 months post treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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