Feasibility of Utilising Brushing Cytology and Dermoscopy for Diagnosing Penile Lesions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Does cytology results compare equally with standard histological biopsy for detecting cancer
研究概览
简要总结
In an attempt to reduce patient flow into the hospital we are going to assess the use of penile cytological brushings and dermoscopy in diagnosing cancer or non-cancer conditions of the penis.
详细描述
Currently the standard of care pathway for all patients suspected of having penile cancer involves the need for a penile biopsy under local (LA) or general anaesthetic (GA). We hope to assess the feasibility of cytololgical brushings and the patient experience of the use of such a technique. Additionally, we will make initial comparison on the concordance between cytological brushing and dermoscope photo vs actual biopsy only.
Importantly for this study, all patients will be offered standard of care: a biopsy under LA or GA. The additional procedures of the cytological brushing and dermoscope photo will be done in an out-patient clinic setting (with no anaesthetic).
If it can be shown that the inclusion of the cytological brushing and dermoscope photo have comparative results over current standard of care histological biopsy, this will provide sufficient evidence to expand this study to acquire more data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All patients requiring either diagnostic biopsy or WLE (wide local excision) of a lesion of the penis
- •Age > 18 years
- •Written informed consent provided by the patient
- •Subject has been scheduled for surgical intervention, with a biopsy procedure being a part of the surgical plan
排除标准
- •Subject is unfit for surgery upon surgeon's assessment.
- •Unable to provide consent
- •Those with terminal disease
- •Those with palpable lymph nodes
- •Other coincident cancers
- •Previous radiotherapy treatment to the penis, bladder, prostate, anus
- •Subject is deprived of liberty or under guardianship
- •Subject is not able to follow and understand the procedures of the study due to mental state or other reasons
研究组 & 干预措施
Research Arm
Each group will undergo the same study procedures; Dermoscope Cytological brushing Complete questionnaire on experience of the cytological brushing SoC treatment
干预措施: Cytological Brushing (Device)
结局指标
主要结局
Does cytology results compare equally with standard histological biopsy for detecting cancer
时间窗: Through study completion, expected to be 12 months
Concordance of cytology vs Histopathology i.e. is the cytology assessment equal to histopathology results when detecting cancer
Does the use of dermoscopy photography enable us to identify abnormal cellular changes that compare equally to the results obtained with standard histological biopsy.
时间窗: Through study completion, expected to be 12 months
Concordance of dermoscopy vs Histopathology in detecting cancer i.e. does the use of dermoscopy photographs enable us to identify cancer and compare equally to results obtained by histopathology
次要结局
- Patient satisfaction with cytological brushing diagnostic method being tested(Through study completion, expected to be 12 months)