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临床试验/NCT05608902
NCT05608902已完成不适用

Structural Description of Skin Biopsies With Dynamic Full-field Optical Coherence Tomography on Suspected Basal Cell Carcinoma Lesions, a Pilot Study

Centre Hospitalier William Morey - Chalon sur Saône1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2022年9月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
1
主要终点
Histopathological analysis of basal cell carcinoma with dynamic full-field optical coherence tomography

研究概览

简要总结

Basal cell carcinoma (BCC) are the most frequent skin cancers. Their incidence is constantly increasing. BCC diagnosis is first clinically suspected and then confirmed following histological examination of either a skin biopsy or the excisional specimen. Surgery is the first-line treatment and some procedures (notably Mohs surgery) require extemporaneous histological analysis of the edges to ensure a complete excision. Such on-site histopathological examination can be time consuming and associated with decreased sensitivity. Skin imaging techniques have already been tested to overcome these limitations and seem promising. Although some of them - such as confocal microscopy - are already even used in vivo, there is to date no report of the use of full-field optical coherence tomography for the diagnosis of BCC.

The DOCTOBA study intends to describe direct histopathological examination of fresh skin biopsy or excisional specimen with dynamic full-field optical coherence tomography.

研究设计

研究类型
Observational
观察模型
Other
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

  • patient > 18 years of age who received skin biopsy or excision of basal cell carcinoma suspected lesion between start study date and primary completion date

排除标准

  • inability to perform dynamic full-field optical coherence tomography observation at the moment of skin biopsy
  • diagnosis of basal cell carcinoma disproved

结局指标

主要结局

Histopathological analysis of basal cell carcinoma with dynamic full-field optical coherence tomography

时间窗: Outcome measure is assessed 15 days following skin biopsy or resection

Provide a better understanding of the ability of dynamic full-field optical coherence tomography to identify and characterize the usual basal cell carcinoma, comprising basaloid cells with a thin pale cytoplasm surrounding round or oval nuclei with a rough granulated chromatin pattern, palisade arrangement, artificially created slits, rather chaotic internal arrangement, mitoses and necrosis ; but also to identify the different sub-types of basal cell carcinoma (nodular, superficial, infiltrating, scleroderma).

次要结局

  • Histopathological analysis of healthy skin with dynamic full-field optical coherence tomography(Outcome measure is assessed 15 days following skin biopsy or resection)

研究者

发起方
Centre Hospitalier William Morey - Chalon sur Saône
申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Maldiney

Doctor

Centre Hospitalier William Morey - Chalon sur Saône

研究点 (1)

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