Feasibility of Utilising Brushing Cytology and Dermoscopy for Diagnosing Penile Lesions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Feasibility of Utilising Brushing Cytology and Dermoscopy for Diagnosing Penile Lesions

Conditions
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Penile Cancer

Intervention / Treatment
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* Device: Cytological Brushing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Patients will be assigned to one of two groups. Each group will receive standard of care and the additional procedures being investigated.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Research Arm<br>Each group will undergo the same study procedures; Dermoscope Cytological brushing Complete questionnaire on experience of the cytological brushing SoC treatment | Device: Cytological Brushing<br>* All participants will undergo cytological brushing to collect cell samples for analysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Does cytology results compare equally with standard histological biopsy for detecting cancer | Concordance of cytology vs Histopathology i.e. is the cytology assessment equal to histopathology results when detecting cancer | Through study completion, expected to be 12 months | 
| Does the use of dermoscopy photography enable us to identify abnormal cellular changes that compare equally to the results obtained with standard histological biopsy. | 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 | Through study completion, expected to be 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with cytological brushing diagnostic method being tested | All patients on study will be asked their views on the cytology brushing technique being used to gauge their satisfaction and experience of the new diagnostic method being tested | Through study completion, expected to be 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Penile cancer, HPV, Cytology testing