Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Penile Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Penile Diseases

Male Urogenital Diseases

Penile Cancer

Each group will undergo the same study procedures; Dermoscope Cytological brushing Complete questionnaire on experience of the cytological brushing SoC treatment

All participants will undergo cytological brushing to collect cell samples for analysis

Cytological Brushing

shira Baram

Vijay Sangar

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.

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.

Patients will be assigned to one of two groups. Each group will receive standard of care and the additional procedures being investigated.

Feasibility of Utilising Brushing Cytology and Dermoscopy for Diagnosing Penile Lesions

no intention to share individual participant data with other researchers outside of the BRUCY research study.

Concordance of cytology vs Histopathology i.e. is the cytology assessment equal to histopathology results when detecting cancer

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Feasibility of Utilising Brushing Cytology and Dermoscopy for Diagnosing Penile Lesions	NCT05662839	Penile Cancer	Cytological Bru...	18 Years -	The Christie NHS Foundation Trust
Feasibility of Utilising Brushing Cytology and Dermoscopy for Diagnosing Penile Lesions	NCT05662839	Penile Cancer	Cytological Bru...	18 Years -	The Christie NHS Foundation Trust

Spots Global Cancer Trial Database for cytology testing