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Feasibility of Utilising Brushing Cytology and Dermoscopy for Diagnosing Penile Lesions

NCT ID: NCT05662839

Last Updated: 2022-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2024-01-31

Brief Summary

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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

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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.

Conditions

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Penile Cancer

Keywords

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Penile cancer HPV Cytology testing

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Research Arm

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

Group Type EXPERIMENTAL

Cytological Brushing

Intervention Type DEVICE

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

Interventions

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Cytological Brushing

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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The Christie NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vijay Sangar

Role: PRINCIPAL_INVESTIGATOR

The Christie NHS FT

Central Contacts

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shira Baram

Role: CONTACT

Phone: 07970271667

Email: [email protected]

Other Identifiers

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CFTSp203

Identifier Type: -

Identifier Source: org_study_id