Clinical trial NCT05662839: Feasibility of Utilising Brushing Cytology and Dermoscopy for Diagnosing Penile Lesions
Official title: Feasibility of Utilising Brushing Cytology and Dermoscopy for Diagnosing Penile Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Penile Cancer
Keywords: Penile cancer
HPV
Cytology testing
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients will be assigned to one of two groups. Each group will receive standard of care and the additional procedures being investigated.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Does cytology results compare equally with standard histological biopsy for detecting cancer
timeFrame: Through study completion, expected to be 12 months
measure: Does the use of dermoscopy photography enable us to identify abnormal cellular changes that compare equally to the results obtained with standard histological biopsy.
timeFrame: Through study completion, expected to be 12 months
Secondary outcomes:
measure: Patient satisfaction with cytological brushing diagnostic method being tested
timeFrame: Through study completion, expected to be 12 months
Other outcomes:
Locations:
Study officials:
affiliation: The Christie NHS FT
name: Vijay Sangar
role: PRINCIPAL_INVESTIGATOR
References: