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临床试验/NCT03382704
NCT03382704撤回不适用

Vellus Hair Loss as a Marker for Peri-ocular Malignancy

NHS Lothian1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
NHS Lothian
入组人数
100
试验地点
1
主要终点
Vellus hair presence/absence

研究概览

简要总结

Skin cancers around the eye are common, but so are other lid lumps. It is useful to be able to tell which lumps are likely to be cancer.

This study looks at whether the loss of fine hairs (vellus hairs) on the skin are a good indicator of whether a lump is a skin cancer or not.

The investigators are recruiting patients who have lid lumps who haven't had a biopsy before, who would be having a biopsy as part of their treatment, and seeing whether those who have loss of the fine skin hairs are the same as those who have skin cancer confirmed on their biopsy.

The study doesn't involve any extra examinations or treatments for participants. The investigators look at the patients before the biopsy as part of their usual care, and take a note of whether or not they have lost the fine hairs at this stage.

The main benefit of participating is that the medical community has better evidence about which lid lumps are likely to represent skin cancer, helping future diagnosis.

There are no additional risks to participating. The risks of biopsy are unchanged whether patients participate in the study or not.

The study is run from the Princess Alexandra Eye Pavilion in Edinburgh.

The investigators aim to start the study in Spring 2020, and will most likely recruit for 6 months depending on the number of participants recruited.

There is no additional funding from any source at present - the work will be undertaken by doctors in their research time.

研究设计

研究类型
Observational
观察模型
Case Only
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
否

入选标准

  • •patients undergoing biopsy for peri-ocular lesion

排除标准

  • •Age under 18; previous biopsy or excision on the same lid

研究组 & 干预措施

Patients undergoing biopsy

Patients undergoing biopsy (incisional or excisional) of peri-ocular lesions. Pre-operative examination for presence or absence of vellus hairs

干预措施: Examination for presence or absence of vellus hairs (Diagnostic Test)

结局指标

主要结局

Vellus hair presence/absence

时间窗: Day 1

Examination for the presence or absence of vellus hairs prior to biopsy

Biopsy result

时间窗: On receipt of biopsy result from pathology lab (~1 week)

Biopsy result looking for malignancy

次要结局

未报告次要终点

研究者

发起方
NHS Lothian
申办方类型
Other Gov
责任方
Sponsor
主要研究者

Robert Peden

Speciality Registrar

NHS Lothian

研究点 (1)

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