跳至主要内容
临床试验/NCT03848078
NCT03848078Unknown不适用

(Cost)-Effectiveness of Optical Coherence Tomography Versus Regular Punch Biopsy in the Diagnosis and Subtyping of Basal Cell Carcinoma: a Multi Center Randomized Non-inferiority Trial

Maastricht University Medical Center2 个研究点 分布在 1 个国家目标入组 598 人开始时间: 2019年2月26日最近更新:
适应症

试验速览

阶段
不适用
入组人数
598
试验地点
2
主要终点
Cost-effectiveness of OCT

研究概览

简要总结

A multi-centre randomized non-inferiority trial investigating the (cost-)effectiveness of Optical Coherence Tomography (OCT) versus regular punch biopsy in the diagnosis and subtyping of Basal Cell Carcinoma (BCC).

详细描述

Skin cancer incidence rises worldwide due to high sun exposure and ageing. Basal cell carcinoma (BCC) is the most prevalent form, with a lifetime risk of 16-20% in the Netherlands. Currently, the gold standard for diagnosing and subtyping BCC is a punch biopsy. Since this technique is invasive, new non-invasive diagnostic methods have been developed, including optical coherence tomography (OCT). In patients with clinical and dermoscopic suspicion of BCC, OCT makes it possible to confirm and subtype BCC with high confidence, thereby obviating the need for a punch biopsy in a substantial part of patients. Hence, BCC diagnosis and treatment can be accomplished in one day. As a result, patients experience less distress and costs can be saved. By discussing diagnosis and treatment with the patient directly, care can be provided more efficiently, preventing treatment delay and saving extra hospital visits. The investigators hypothesize that the use of OCT is a cost-effective strategy when compared to regular care (always punch biopsy). However, it is important to evaluate whether an alternative OCT guided diagnostic approach does not lead to an unacceptable increase in risk of recurrent BCC.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Investigator)

盲法说明

The investigator is blinded for the result of the punch biopsy.

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 (>18 years)
  • Clinical and dermoscopic suspicion of BCC
  • BCC is in the differential diagnosis and a biopsy would normally be obtained to confirm the diagnosis and subtype or exclude other skin lesions.

排除标准

  • Patients with BCC in the high-risk zone of the face (ear, nose, eye region)
  • Patients with a large BCC referred to our (tertiary care) head and neck tumour working group.

结局指标

主要结局

Cost-effectiveness of OCT

时间窗: 12 months

The main endpoint for the cost-effectiveness analysis is the Incremental Cost-Effectiveness Ratio (ICER) defined as extra cost per gained Quality-Adjusted Life Year (QALY).

Proportion of patients with treatment failure

时间窗: 12 months

The main endpoint for the non-inferiority trial is the proportion of patients with treatment failure after 12 months follow-up, where treatment failure is defined as inadequate treatment or recurrence of malignant or premalignant lesions.

次要结局

  • The proportion of patients with avoided biopsies(12 months)
  • Diagnostic performance of OCT(12 months)
  • Discrete Choice Experiment to determine patient preferences(2 months)
  • Quality of life measured with EQ-5D-5L(Baseline, 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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