跳至主要内容
临床试验/NCT06273709
NCT06273709尚未招募不适用

The Value of Visual Inspection When Remotely Diagnosing Basal Cell Carcinoma on Optical Coherence Tomography Scans: a Diagnostic Case-control Study

Maastricht University Medical Center0 个研究点目标入组 120 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
主要终点
Diagnostic accuracy of high-confidence BCC diagnosis with and without clinical/dermoscopic photographs

研究概览

简要总结

Basal cell carcinoma (BCC) is the most common form of cancer and entails approximately 80% of all cutaneous malignancies. This locally destructive neoplasm is commonly diagnosed by punch biopsy which is considered painful, causes procedural scarring and carries a small risk of infection and re-bleeding associated with invasive procedures. Moreover, awaiting the results of the subsequent histopathological examination causes treatment delay and can be stressful for the patient. The drawbacks of biopsy could be overcome by optical coherence tomography (OCT), a non-invasive diagnostic modality that may replace biopsy in up to 66% of patients. However, OCT assessors are scarce which hinders the implementation of OCT. This problem may be addressed by teledermatology in which remote OCT assessment by an assessor facilitates simultaneous assessment for multiple clinics. Remote OCT assessment withholds the OCT assessor from visually inspecting the lesion. But the effect of visual inspection on the diagnostic accuracy remains unknown and the question arises whether visual inspection is necessary for accurate OCT assessment. In this diagnostic case-control study we will determine whether distant OCT assessment without visual information on the lesion is non-inferior to distant OCT assessment with clinical and dermoscopic photographs (CDP-OCT).

研究设计

研究类型
Observational
观察模型
Case Control
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

  • 18+ years of age
  • Underwent OCT scan and punch biopsy for lesions suspect for BCC

排除标准

  • Unable to sign informed consent

结局指标

主要结局

Diagnostic accuracy of high-confidence BCC diagnosis with and without clinical/dermoscopic photographs

时间窗: Measured before December 31st 2024

Diagnostic accuracy of a high confidence diagnosis (confidence-score 4) will be expressed by diagnostic parameters, such as sensitivity, specificity, positive predictive value (PPV), negative predicitive value (NPV), and diagnostic odds ratios (DOR) with 95% confidence intervals. The primary outcome in this study is specificity of a high confidence diagnosis, defined as the proportion of histological non-BCC lesions that are classified as non-BCC on OCT.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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