Feasibility of Utilising Brushing Cytology and Dermoscopy for Diagnosing Penile Lesions

Not Applicable

Not yet recruiting

• Conditions: Penile Cancer
• Interventions: Device: Cytological Brushing

• Registration Number: NCT05662839
• Lead Sponsor: The Christie NHS Foundation Trust

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-10-03
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-20
• Last Update Submitted: 2022-12-20
• Study First Posted: 2022-12-23
• Last Update Posted: 2022-12-23
• Study Start: 2023-01
• Primary Completion: 2024-01
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

1. All patients requiring either diagnostic biopsy or WLE (wide local excision) of a lesion of the penis
2. Age > 18 years
3. Written informed consent provided by the patient
4. Subject has been scheduled for surgical intervention, with a biopsy procedure being a part of the surgical plan

Exclusion Criteria

1. Subject is unfit for surgery upon surgeon's assessment.
2. Unable to provide consent
3. Those with terminal disease
4. Those with palpable lymph nodes
5. Other coincident cancers
6. Previous radiotherapy treatment to the penis, bladder, prostate, anus
7. Subject is deprived of liberty or under guardianship
8. Subject is not able to follow and understand the procedures of the study due to mental state or other reasons

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Research Arm	Cytological Brushing	Each group will undergo the same study procedures; Dermoscope Cytological brushing Complete questionnaire on experience of the cytological brushing SoC treatment

Primary Outcome Measures

Name	Time	Method
Does cytology results compare equally with standard histological biopsy for detecting cancer	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.	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

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction with cytological brushing diagnostic method being tested	Through study completion, expected to be 12 months	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