Penile CancerBRUCYNCT05662839
Feasibility of Utilising Brushing Cytology and Dermoscopy for Diagnosing Penile Lesions
A study testing Cytological Brushing in people with Penile Cancer, run by The Christie NHS Foundation Trust.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Penile Cancer
- What is being tested?
- Cytological Brushing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Penile Cancer
- Being tested
- Cytological Brushing
- Keywords
- Penile cancer, HPV, Cytology testing
- Medical subject headings
- Penile Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytological BrushingDevice
All participants will undergo cytological brushing to collect cell samples for analysis
| Study group | Role | What they receive |
|---|---|---|
| Research Arm | Experimental | Each group will undergo the same study procedures; Dermoscope Cytological brushing Complete questionnaire on experience of the cytological brushing SoC treatment Receives: Device: Cytological Brushing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Through study completion, expected to be 12 months
Secondary outcomes (1)
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
Measured: Through study completion, expected to be 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study startJan 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penile CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients will be assigned to one of two groups. Each group will receive standard of care and the additional procedures being investigated.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vijay Sangar, Principal investigator, The Christie NHS FT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662839
- Sponsor's protocol ID
- CFTSp203
- Acronym
- BRUCY
- Status last verified
- Dec 2022
- First submitted
- 3 Oct 2022
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no intention to share individual participant data with other researchers outside of the BRUCY research study.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Utilising Brushing Cytology and Dermoscopy for Diagnosing Penile Lesions
- ClinicalTrials.gov ID
- NCT05662839
- Acronym / sponsor ID
- BRUCY / CFTSp203
- Conditions
- Penile Cancer
- Keywords
- Penile cancer, HPV, Cytology testing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 23 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will be assigned to one of two groups. Each group will receive standard of care and the additional procedures being investigated.
| Arm | Type | Receives |
|---|---|---|
| Research Arm | Experimental | Device: Cytological BrushingEach group will undergo the same study procedures; Dermoscope Cytological brushing Complete questionnaire on experience of the cytological brushing SoC treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytological BrushingAll participants will undergo cytological brushing to collect cell samples for analysis | Device | Research Arm |
Primary outcome
Does cytology results compare equally with standard histological biopsy for detecting cancer
Time frame: Through study completion, expected to be 12 months
Concordance of cytology vs Histopathology i.e. is the cytology assessment equal to histopathology results when detecting cancer
Does the use of dermoscopy photography enable us to identify abnormal cellular changes that compare equally to the results obtained with standard histological biopsy.
Time frame: Through study completion, expected to be 12 months
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
1 secondary outcome
Patient satisfaction with cytological brushing diagnostic method being tested
Time frame: Through study completion, expected to be 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Individual participant dataSharing planned: No. no intention to share individual participant data with other researchers outside of the BRUCY research study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vijay Sangar principal investigator
The Christie NHS FT
Questions about this trial
What is this clinical trial studying?
A study testing Cytological Brushing in people with Penile Cancer, run by The Christie NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact shira Baram (07970271667, shira.baram@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Does cytology results compare equally with standard histological biopsy for detecting cancer (time frame: Through study completion, expected to be 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.