Feasibility of Utilising Brushing Cytology and Dermoscopy for Diagnosing Penile Lesions

Penile Cancer Clinical Trial

— BRUCY  

Official title:

Feasibility of Utilising Brushing Cytology and Dermoscopy for Diagnosing Penile Lesions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05662839
• Other study ID #: CFTSp203
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2023
• Est. completion date: January 2024

Study information

• Verified date: December 2022
• Source: The Christie NHS Foundation Trust
• Contact: shira Baram
• Phone: 07970271667
• Email: shira.baram[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Penile Cancer
• Penile Neoplasms

Intervention

Device:
• Cytological Brushing
All participants will undergo cytological brushing to collect cell samples for analysis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Christie NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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