Multicenter, Randomised Study of the Impact of Advanced, Non-invasive Diagnostic Instrumentation for Early Cutaneous Tumor Diagnosis, Clinical-therapeutic Pathways and an Economic-management Perspective
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,248
- 主要终点
- Number needed to excise (NNE)
研究概览
简要总结
The incidence of cutaneous melanoma (MM) is increasing worldwide. The best therapeutical solution for MM is early diagnosis and efforts over the last 50 years have been directed towards early and precise diagnoses.
Dermoscopy has improved diagnostic accuracy compared to the naked eye, but is limited by an associated higher number of unnecessary excisions. Reflectance confocal microscopy (RCM) is a novel technique enabling in vivo examination of the skin at cellular-level resolution, with excellent diagnostic accuracy.
This study hypothesis is that the systematic application of RCM in the triage and management of patients suspicious for skin cancer, may improve diagnostic accuracy and reduce the number of unnecessary biopsy. Reducing the burden of unnecessary surgery excisions should benefit the health system, both in saving surgical and pathology procedural associated costs and reducing the overwhelming waiting lists for excisions and consequent risk for delayed diagnoses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Care Provider)
盲法说明
Randomisation of patients to Arm 1 (with RCM evaluation) or Arm 2 (without RCM evaluations) was performed following clinical and dermoscopy evaluation, and was only revealed to the clinician at presentation of RCM evaluation request.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient's with at least 1 unequivocal lesion following standard of care (clinical and dermoscopy evaluations), >= 18 years old
排除标准
- •(i) the presence of an unequivocal aspect of melanoma or of any other malignant skin cancer,
- •(ii) lesion located on a skin area where reflectance confocal microscopy cannot be performed (for example: skin folds, mucosa, etc.),
- •(iii) lesion larger than 2 cm in its largest diameter
- •(iv) lesion where RCM examination is hampered for over the 30% of its surface (for example, for presence of crusting, oozing, erosion, ulceration, etc.).
研究组 & 干预措施
Arm 1 (interventional)
Patients with equivocal skin lesions suspicious for melanoma, randomised to adjunctive RCM evaluation, following clinical and dermoscopy evaluation.
干预措施: Clinical, dermoscopy and Reflective confocal microscopy evaluations (Device)
Arm 2 (control)
Patients with equivocal skin lesions suspicious for melanoma, randomised to clinical and dermoscopy evaluation only; adjunctive RCM evaluation refused.
干预措施: Clinical, dermoscopy evaluations (Device)
结局指标
主要结局
Number needed to excise (NNE)
时间窗: 03/2016 - 02/2020
Measure the number of lesions needed to excise for a cutaneous melanoma diagnosis
Early diagnosis
时间窗: 03/2016 - 02/2020
Measure the breslow index of excised lesions
RCM diagnostic sensibility and sensitivity
时间窗: 03/2016 - 02/2020
Diagnostic sensibility of RCM in identifying cutaneous melanoma among equivocal lesions suspicious for melanoma (without clear demoscopy criteria for melanoma)
次要结局
- Head and neck pigmented lesions(03/2016 - 02/2020)
- Diagnostic accuracy of non melanoma skin cancer(03/2016 - 02/2020)
研究者
Pellacani Giovanni
Professor of Dermatology
Azienda Ospedaliero-Universitaria di Modena