Feasibility of Utilising Brushing Cytology and Dermoscopy for Diagnosing Penile Lesions

NCT05662839 | Unknown

• 1 other identifier: CFTSp203
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Penile Cancer

Keywords

Penile cancer; HPV; Cytology testing

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Patient satisfaction with cytological brushing diagnostic method being tested

  Through study completion, expected to be 12 months

Study Arms (1)

Research Arm

EXPERIMENTAL

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

Device: Cytological Brushing

Interventions

Cytological Brushing DEVICE

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

Research Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients requiring either diagnostic biopsy or WLE (wide local excision) of a lesion of the penis
• Age \> 18 years
• Written informed consent provided by the patient
• Subject has been scheduled for surgical intervention, with a biopsy procedure being a part of the surgical plan

You may not qualify if:

• Subject is unfit for surgery upon surgeon's assessment.
• Unable to provide consent
• Those with terminal disease
• Those with palpable lymph nodes
• Other coincident cancers
• Previous radiotherapy treatment to the penis, bladder, prostate, anus
• Subject is deprived of liberty or under guardianship
• Subject is not able to follow and understand the procedures of the study due to mental state or other reasons

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead

MeSH Terms

Conditions

Penile Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Penile Diseases; Male Urogenital Diseases

Study Officials

• Vijay Sangar

  The Christie NHS FT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

shira Baram

CONTACT

07970271667; shira.baram@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: December 23, 2022
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share