Feasibility of Utilising Brushing Cytology and Dermoscopy for Diagnosing Penile Lesions (BRUCY)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Penile Cancer
• Intervention / Treatment: Device: Cytological Brushing

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: shira Baram; Phone Number: 07970271667; Email: shira.baram@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Christie NHS Foundation Trust
• Investigators: Principal Investigator: Vijay Sangar, The Christie NHS FT

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: October 3, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Actual): December 23, 2022

Study Record Updates

• Last Update Posted (Actual): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: HPV; Penile cancer; Cytology testing
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Penile Diseases; Penile Neoplasms
• Other Study ID Numbers: CFTSp203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: no intention to share individual participant data with other researchers outside of the BRUCY research study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No