Clinical trial · Interventional
Feasibility of Utilising Brushing Cytology and Dermoscopy for Diagnosing Penile Lesions
NCT05662839CI-TRIAL-00062881BRUCYunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Penile Cancer | Malignant Penile Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytological Brushing | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Research Arm
- description
- Each group will undergo the same study procedures; Dermoscope Cytological brushing Complete questionnaire on experience of the cytological brushing SoC treatment
- interventionNames
- Device: Cytological Brushing
Primary outcomes (2)
- measure
- Does cytology results compare equally with standard histological biopsy for detecting cancer
- timeFrame
- Through study completion, expected to be 12 months
- description
- Concordance of cytology vs Histopathology i.e. is the cytology assessment equal to histopathology results when detecting cancer
- 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
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.