Basal Cell CarcinomaNCT03509415
Reflectance Confocal Microscopy to Diagnose BCC
An observational study of Basal Cell Carcinoma, run by Skin Care Network Ltd. at 1 site in United Kingdom.
Trial summary
It is proposed to undertake a study to determine the diagnostic utility of using RCM for the diagnosis of Basal Cell Carcinoma (BCC) in a tertiary referral centre as outlined by the recent NICE report (Nov 2015). This will allow an assessment of the potential to avoid diagnostic biopsy within the treatment pathway. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- In-vivo imaging
- How many people
- 324 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Mar 2017to 28 Dec 2019
- Phase
- Observational
- 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
- All sexes
- Adult, Older adult
Study population: Patients presenting at a skin cancer clinic with a lesion that is clinically suspicious for BCC
Who may be able to join
- Age 18 years or older
- Patient suspected of having a primary basal cell carcinoma that is a candidate for surgical treatment.
- Patient willing and able to give informed consent
Who cannot join
- Recurrent or other higher-risk BCC
- Patient with basal cell naevus syndrome
- Patient treated with hedgehog inhibitor medication (vismodegib)
- Patient not suitable for diagnostic biopsy
- Location of lesion unsuitable, inaccessible or impractical for scanning with RCM as determined by investigator
- Patient with co-morbidities such as other skin disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reflectance Confocal Microscopy to Diagnose Basal Cell Carcinoma
It is proposed to undertake a study to determine the diagnostic utility of using RCM for the diagnosis of Basal Cell Carcinoma (BCC) in a tertiary referral centre as outlined by the recent NICE report (Nov 2015). This will allow an assessment of the potential to avoid diagnostic biopsy within the treatment pathway.
Read the detailed description
Study Design This is an observational, non-randomised, non-controlled, prospective cohort study to look at the efficacy of in vivo RCM as a diagnostic tool in the diagnosis of BCC.
Study Hypothesis The hypothesis of this study is that the use of RCM is would enable a reduction in the number of diagnostic biopsies taken before definitive treatment of BCC by at least 50%.
The secondary hypothesis is that the intra- \& inter-observer agreement for interpreting the RCM images will have kappa scores 0.6 or greater (indicating good agreement).
Patients will be recruited from the outpatient clinic of Skin Care Network London.
- Conditions
- Basal Cell Carcinoma
- Being tested
- In-vivo imaging
- Keywords
- Confocal, RCM, Imaging, Skin cancer
- Medical subject headings
- Carcinoma, Basal Cell, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-vivo imagingDiagnostic test
Skin cancer is imaged using RCM and a diagnosis is recorded before patient is returned to standard of care (biopsy).
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity
Specificity \& Sensitivity of RCM in diagnosing Basal Cell Carcinoma in non-pigmented lesions compared to standard histology
Measured: During exam (biopsy results typically available within one week).
Secondary outcomes (1)
intra- & inter-observer agreement for interpreting the RCM images
A measure of how consistently readers can diagnose from confocal images.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start15 Mar 2017
- Primary completion28 Dec 2019
- Study completion28 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Basal Cell CarcinomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skin Care Network Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Howard Stevens, MA PhD, Principal investigator, Skin Care Network Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509415
- Sponsor's protocol ID
- HS-MAV-003
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2018
- Last updated
- 16 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stevens HP, Pampena R, Farnetani F, Pellacani G, Angus C, El-Jabbour JN. Reflectance confocal microscopy in diagnosing basal cell carcinoma in the UK: a prospective observational single-centre trial. Br J Dermatol. 2025 Jan 24;192(2):206-214. doi: 10.1093/bjd/ljae356.
PubMed 39259284
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reflectance Confocal Microscopy to Diagnose Basal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03509415
- Acronym / sponsor ID
- HS-MAV-003
- Conditions
- Basal Cell Carcinoma
- Keywords
- Confocal, RCM, Imaging, Skin cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Skin Care Network Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 28 Dec 2019 (actual)
- Study completion
- 28 Dec 2019 (actual)
- First posted
- 26 Apr 2018 (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.
It is proposed to undertake a study to determine the diagnostic utility of using RCM for the diagnosis of Basal Cell Carcinoma (BCC) in a tertiary referral centre as outlined by the recent NICE report (Nov 2015). This will allow an assessment of the potential to avoid diagnostic biopsy within the treatment pathway.
Detailed description
Study Design This is an observational, non-randomised, non-controlled, prospective cohort study to look at the efficacy of in vivo RCM as a diagnostic tool in the diagnosis of BCC.
Study Hypothesis The hypothesis of this study is that the use of RCM is would enable a reduction in the number of diagnostic biopsies taken before definitive treatment of BCC by at least 50%.
The secondary hypothesis is that the intra- \& inter-observer agreement for interpreting the RCM images will have kappa scores 0.6 or greater (indicating good agreement).
Patients will be recruited from the outpatient clinic of Skin Care Network London.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients presenting at a skin cancer clinic with a lesion that is clinically suspicious for BCC
Key inclusion criteria (3 listed)
- Age 18 years or older
- Patient suspected of having a primary basal cell carcinoma that is a candidate for surgical treatment.
- Patient willing and able to give informed consent
Key exclusion criteria (6 listed)
- Recurrent or other higher-risk BCC
- Patient with basal cell naevus syndrome
- Patient treated with hedgehog inhibitor medication (vismodegib)
- Patient not suitable for diagnostic biopsy
- Location of lesion unsuitable, inaccessible or impractical for scanning with RCM as determined by investigator
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 |
|---|---|---|
| In-vivo imagingSkin cancer is imaged using RCM and a diagnosis is recorded before patient is returned to standard of care (biopsy). | Diagnostic test | – |
Primary outcome
Sensitivity and Specificity
Time frame: During exam (biopsy results typically available within one week).
Specificity \& Sensitivity of RCM in diagnosing Basal Cell Carcinoma in non-pigmented lesions compared to standard histology
1 secondary outcome
intra- & inter-observer agreement for interpreting the RCM images
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Derived from this study: PubMed 39259284Stevens HP, Pampena R, Farnetani F, Pellacani G, Angus C, El-Jabbour JN. Reflectance confocal microscopy in diagnosing basal cell carcinoma in the UK: a prospective observational single-centre trial. Br J Dermatol. 2025 Jan 24;192(2):206-214. doi: 10.1093/bjd/ljae356.
- Individual participant dataSharing planned: No
Related trials for Basal Cell Carcinoma
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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.
Howard Stevens, MA PhD principal investigator
Skin Care Network Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Basal Cell Carcinoma, run by Skin Care Network Ltd. at 1 site in United Kingdom.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity (time frame: During exam (biopsy results typically available within one week).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03509415, which also lists 1 linked publication.
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 16 Apr 2024.