Basal Cell CarcinomaRCM-1NCT03331874
RCM to Diagnose BCC - Reflectance Confocal Microscopy to Diagnose Basal Cell Carcinoma
An observational study of Basal Cell Carcinoma, run by Julie Dawson at 1 site in United Kingdom.
Trial summary
Basal cell carcinoma (BCC) is the commonest non melanoma skin cancer in the UK and its incidence is rising. The Norfolk and Norwich University Hospital Foundation Trust (NNUHFT) see and excise approximately 3,000 new cases of BCC each year. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- Reflectance Confocal Microscopy
- How many people
- 352 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Mar 2017to 31 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: See Above
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Norfolk & Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, NR4 7UY
About this study
Official title: Reflectance Confocal Microscopy to Diagnose Basal Cell Carcinoma
Basal cell carcinoma (BCC) is the commonest non melanoma skin cancer in the UK and its incidence is rising. The Norfolk and Norwich University Hospital Foundation Trust (NNUHFT) see and excise approximately 3,000 new cases of BCC each year. Many of these patients have a biopsy to confirm their diagnosis before being listed for surgical excision. In vivo reflectance confocal microscopy (RCM) involves using a machine which can examine the upper layers of the skin non invasively.
In clinically suspicious lesions, the Investigators will use RCM prior to biopsy with the aim of demonstrating that RCM can accurately diagnose BCC. The aim of this study is to determine the feasibility and utility of using RCM for the diagnosis of BCC in the NHS setting, thereby shortening the patient pathway and effectively using limited public resources. If the Investigators' study shows that RCM can accurately diagnose BCC in these patients then this would prevent the need for biopsy as a routine in these patients.
Read the detailed description
Patients will be recruited from the outpatient clinics of the Departments of Dermatology and Plastic Surgery at the Norfolk and Norwich University Hospital Foundation Trust. These will be patients who have been assessed in clinic by a consultant dermatologist or consultant plastic surgeon. They will be suspected of having a BCC on the head and neck region. Clinical and dermoscopic (a dermatoscope is a hand held microscope) images will be taken by the Medical Illustration at NNUHFT as part of their routine standard of care. Patients will be invited to participate in the trial and provided with a patient information leaflet. They will be given sufficient time to review the information sheet and ask questions. Patients will be consented to having reflectance confocal microscopy performed of the target lesion before undergoing biopsy for histology. These patients would be having photographs, including dermoscopic images, and a biopsy as part of their standard of care prior to their final treatment being determined - the only additional intervention is examination with the confocal microscope.
The images taken of the tumour by the reflectance confocal microscope will be anonymised. These images will then be examined by a different in house dermatologist who has undergone training in examining confocal images. The images will also be sent to a dermatologist in Modena, Italy who is experienced in interpreting confocal microscopic images - both of these dermatologists will be blinded as to the patient's history and the results of the punch biopsy.
The biopsies will undergo routine processing in our histopathology laboratory as normal and will be analysed by a pathologist who will be unaware of the findings on confocal microscopy.
The patients will undergo one additional intervention over-and-above their standard investigation and treatment pathway. The treatment pathway for the patients will not be lengthened or shortened by their participation.
- Conditions
- Basal Cell Carcinoma
- Being tested
- Reflectance Confocal Microscopy
- Keywords
- confocal, basal, carcinoma
- Medical subject headings
- Carcinoma, Basal Cell, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reflectance Confocal MicroscopyDiagnostic test
In-vivo microscope
| Study group | Role | What they receive |
|---|---|---|
| Basal Cell Carcinoma | Diagnosis of Basal Cell Carcinoma by Reflectance confocal microscopy Receives: Diagnostic Test: Reflectance Confocal Microscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity & Sensitivity of RCM in diagnosing BCC compared to standard histology
Specificity \& Sensitivity of RCM in diagnosing BCC compared to standard histology
Measured: 18 months
Secondary outcomes (1)
Inter- & intra-observer agreement in assessing RCM images
Inter- \& intra-observer agreement in assessing RCM images
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start3 Mar 2017
- Primary completion27 Nov 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Julie Dawson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Julie Dawson, Norfolk and Norwich University Hospitals NHS Foundation Trust
- Investigators
- Jennifer Garioch, Dr, Principal investigator, Consultant Oncologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331874
- Sponsor's protocol ID
- 206698(59-03-16)
- Acronym
- RCM-1
- Status last verified
- Oct 2020
- First submitted
- 1 Nov 2017
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Levell NJ, Igali L, Wright KA, Greenberg DC. Basal cell carcinoma epidemiology in the UK: the elephant in the room. Clin Exp Dermatol. 2013 Jun;38(4):367-9. doi: 10.1111/ced.12016. Epub 2013 Mar 18.
PubMed 23496262Sauermann K, Gambichler T, Wilmert M, Rotterdam S, Stucker M, Altmeyer P, Hoffmann K. Investigation of basal cell carcinoma [correction of carcionoma] by confocal laser scanning microscopy in vivo. Skin Res Technol. 2002 Aug;8(3):141-7. doi: 10.1034/j.1600-0846.2002.20345.x.
PubMed 12236882Gonzalez S, Tannous Z. Real-time, in vivo confocal reflectance microscopy of basal cell carcinoma. J Am Acad Dermatol. 2002 Dec;47(6):869-74. doi: 10.1067/mjd.2002.124690.
PubMed 12451371Goldgeier M, Fox CA, Zavislan JM, Harris D, Gonzalez S. Noninvasive imaging, treatment, and microscopic confirmation of clearance of basal cell carcinoma. Dermatol Surg. 2003 Mar;29(3):205-10. doi: 10.1046/j.1524-4725.2003.29050.x.
PubMed 12614409Marra DE, Torres A, Schanbacher CF, Gonzalez S. Detection of residual basal cell carcinoma by in vivo confocal microscopy. Dermatol Surg. 2005 May;31(5):538-41. doi: 10.1111/j.1524-4725.2005.31157.
PubMed 15962737Nori S, Rius-Diaz F, Cuevas J, Goldgeier M, Jaen P, Torres A, Gonzalez S. Sensitivity and specificity of reflectance-mode confocal microscopy for in vivo diagnosis of basal cell carcinoma: a multicenter study. J Am Acad Dermatol. 2004 Dec;51(6):923-30. doi: 10.1016/j.jaad.2004.06.028.
PubMed 15583584Longo C, Farnetani F, Ciardo S, Cesinaro AM, Moscarella E, Ponti G, Zalaudek I, Argenziano G, Pellacani G. Is confocal microscopy a valuable tool in diagnosing nodular lesions? A study of 140 cases. Br J Dermatol. 2013 Jul;169(1):58-67. doi: 10.1111/bjd.12259.
PubMed 23374159Gerger A, Koller S, Weger W, Richtig E, Kerl H, Samonigg H, Krippl P, Smolle J. Sensitivity and specificity of confocal laser-scanning microscopy for in vivo diagnosis of malignant skin tumors. Cancer. 2006 Jul 1;107(1):193-200. doi: 10.1002/cncr.21910.
PubMed 16615102Eichert S, Mohrle M, Breuninger H, Rocken M, Garbe C, Bauer J. Diagnosis of cutaneous tumors with in vivo confocal laser scanning microscopy. J Dtsch Dermatol Ges. 2010 Jun;8(6):400-10. doi: 10.1111/j.1610-0387.2010.07333.x. Epub 2010 Feb 5. English, German.
PubMed 20141551Guitera P, Menzies SW, Longo C, Cesinaro AM, Scolyer RA, Pellacani G. In vivo confocal microscopy for diagnosis of melanoma and basal cell carcinoma using a two-step method: analysis of 710 consecutive clinically equivocal cases. J Invest Dermatol. 2012 Oct;132(10):2386-2394. doi: 10.1038/jid.2012.172. Epub 2012 Jun 21.
PubMed 22718115Peppelman M, Wolberink EA, Blokx WA, van de Kerkhof PC, van Erp PE, Gerritsen MJ. In vivo diagnosis of basal cell carcinoma subtype by reflectance confocal microscopy. Dermatology. 2013;227(3):255-62. doi: 10.1159/000354762. Epub 2013 Oct 18.
PubMed 24158236Castro RP, Stephens A, Fraga-Braghiroli NA, Oliviero MC, Rezze GG, Rabinovitz H, Scope A. Accuracy of in vivo confocal microscopy for diagnosis of basal cell carcinoma: a comparative study between handheld and wide-probe confocal imaging. J Eur Acad Dermatol Venereol. 2015 Jun;29(6):1164-9. doi: 10.1111/jdv.12780. Epub 2014 Oct 22.
PubMed 25338750
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. 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
- NCT03331874
- Acronym / sponsor ID
- RCM-1 / 206698(59-03-16)
- Conditions
- Basal Cell Carcinoma
- Keywords
- confocal, basal, carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Julie DawsonUniversity, hospital or other
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 27 Nov 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 6 Nov 2017 (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.
Basal cell carcinoma (BCC) is the commonest non melanoma skin cancer in the UK and its incidence is rising. The Norfolk and Norwich University Hospital Foundation Trust (NNUHFT) see and excise approximately 3,000 new cases of BCC each year. Many of these patients have a biopsy to confirm their diagnosis before being listed for surgical excision. In vivo reflectance confocal microscopy (RCM) involves using a machine which can examine the upper layers of the skin non invasively.
In clinically suspicious lesions, the Investigators will use RCM prior to biopsy with the aim of demonstrating that RCM can accurately diagnose BCC. The aim of this study is to determine the feasibility and utility of using RCM for the diagnosis of BCC in the NHS setting, thereby shortening the patient pathway and effectively using limited public resources. If the Investigators' study shows that RCM can accurately diagnose BCC in these patients then this would prevent the need for biopsy as a routine in these patients.
Detailed description
Patients will be recruited from the outpatient clinics of the Departments of Dermatology and Plastic Surgery at the Norfolk and Norwich University Hospital Foundation Trust. These will be patients who have been assessed in clinic by a consultant dermatologist or consultant plastic surgeon. They will be suspected of having a BCC on the head and neck region. Clinical and dermoscopic (a dermatoscope is a hand held microscope) images will be taken by the Medical Illustration at NNUHFT as part of their routine standard of care. Patients will be invited to participate in the trial and provided with a patient information leaflet. They will be given sufficient time to review the information sheet and ask questions. Patients will be consented to having reflectance confocal microscopy performed of the target lesion before undergoing biopsy for histology. These patients would be having photographs, including dermoscopic images, and a biopsy as part of their standard of care prior to their final treatment being determined - the only additional intervention is examination with the confocal microscope.
The images taken of the tumour by the reflectance confocal microscope will be anonymised. These images will then be examined by a different in house dermatologist who has undergone training in examining confocal images. The images will also be sent to a dermatologist in Modena, Italy who is experienced in interpreting confocal microscopic images - both of these dermatologists will be blinded as to the patient's history and the results of the punch biopsy.
The biopsies will undergo routine processing in our histopathology laboratory as normal and will be analysed by a pathologist who will be unaware of the findings on confocal microscopy.
The patients will undergo one additional intervention over-and-above their standard investigation and treatment pathway. The treatment pathway for the patients will not be lengthened or shortened by their participation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Basal Cell Carcinoma | – | Diagnostic Test: Reflectance Confocal MicroscopyDiagnosis of Basal Cell Carcinoma by Reflectance confocal microscopy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- See Above
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Reflectance Confocal MicroscopyIn-vivo microscope | Diagnostic test | Basal Cell Carcinoma |
Primary outcome
Specificity & Sensitivity of RCM in diagnosing BCC compared to standard histology
Time frame: 18 months
Specificity \& Sensitivity of RCM in diagnosing BCC compared to standard histology
1 secondary outcome
Inter- & intra-observer agreement in assessing RCM images
Time frame: 18 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 8 Oct 2020.
- Background: PubMed 23496262Levell NJ, Igali L, Wright KA, Greenberg DC. Basal cell carcinoma epidemiology in the UK: the elephant in the room. Clin Exp Dermatol. 2013 Jun;38(4):367-9. doi: 10.1111/ced.12016. Epub 2013 Mar 18.
- Background: PubMed 12236882Sauermann K, Gambichler T, Wilmert M, Rotterdam S, Stucker M, Altmeyer P, Hoffmann K. Investigation of basal cell carcinoma [correction of carcionoma] by confocal laser scanning microscopy in vivo. Skin Res Technol. 2002 Aug;8(3):141-7. doi: 10.1034/j.1600-0846.2002.20345.x.
- Background: PubMed 12451371Gonzalez S, Tannous Z. Real-time, in vivo confocal reflectance microscopy of basal cell carcinoma. J Am Acad Dermatol. 2002 Dec;47(6):869-74. doi: 10.1067/mjd.2002.124690.
- Background: PubMed 12614409Goldgeier M, Fox CA, Zavislan JM, Harris D, Gonzalez S. Noninvasive imaging, treatment, and microscopic confirmation of clearance of basal cell carcinoma. Dermatol Surg. 2003 Mar;29(3):205-10. doi: 10.1046/j.1524-4725.2003.29050.x.
- Background: PubMed 15962737Marra DE, Torres A, Schanbacher CF, Gonzalez S. Detection of residual basal cell carcinoma by in vivo confocal microscopy. Dermatol Surg. 2005 May;31(5):538-41. doi: 10.1111/j.1524-4725.2005.31157.
- Background: PubMed 15583584Nori S, Rius-Diaz F, Cuevas J, Goldgeier M, Jaen P, Torres A, Gonzalez S. Sensitivity and specificity of reflectance-mode confocal microscopy for in vivo diagnosis of basal cell carcinoma: a multicenter study. J Am Acad Dermatol. 2004 Dec;51(6):923-30. doi: 10.1016/j.jaad.2004.06.028.
- Background: PubMed 23374159Longo C, Farnetani F, Ciardo S, Cesinaro AM, Moscarella E, Ponti G, Zalaudek I, Argenziano G, Pellacani G. Is confocal microscopy a valuable tool in diagnosing nodular lesions? A study of 140 cases. Br J Dermatol. 2013 Jul;169(1):58-67. doi: 10.1111/bjd.12259.
- Background: PubMed 16615102Gerger A, Koller S, Weger W, Richtig E, Kerl H, Samonigg H, Krippl P, Smolle J. Sensitivity and specificity of confocal laser-scanning microscopy for in vivo diagnosis of malignant skin tumors. Cancer. 2006 Jul 1;107(1):193-200. doi: 10.1002/cncr.21910.
- Background: PubMed 20141551Eichert S, Mohrle M, Breuninger H, Rocken M, Garbe C, Bauer J. Diagnosis of cutaneous tumors with in vivo confocal laser scanning microscopy. J Dtsch Dermatol Ges. 2010 Jun;8(6):400-10. doi: 10.1111/j.1610-0387.2010.07333.x. Epub 2010 Feb 5. English, German.
- Background: PubMed 22718115Guitera P, Menzies SW, Longo C, Cesinaro AM, Scolyer RA, Pellacani G. In vivo confocal microscopy for diagnosis of melanoma and basal cell carcinoma using a two-step method: analysis of 710 consecutive clinically equivocal cases. J Invest Dermatol. 2012 Oct;132(10):2386-2394. doi: 10.1038/jid.2012.172. Epub 2012 Jun 21.
- Background: PubMed 24158236Peppelman M, Wolberink EA, Blokx WA, van de Kerkhof PC, van Erp PE, Gerritsen MJ. In vivo diagnosis of basal cell carcinoma subtype by reflectance confocal microscopy. Dermatology. 2013;227(3):255-62. doi: 10.1159/000354762. Epub 2013 Oct 18.
- Background: PubMed 25338750Castro RP, Stephens A, Fraga-Braghiroli NA, Oliviero MC, Rezze GG, Rabinovitz H, Scope A. Accuracy of in vivo confocal microscopy for diagnosis of basal cell carcinoma: a comparative study between handheld and wide-probe confocal imaging. J Eur Acad Dermatol Venereol. 2015 Jun;29(6):1164-9. doi: 10.1111/jdv.12780. Epub 2014 Oct 22.
- Individual participant dataSharing planned: No
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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.
Jennifer Garioch, Dr principal investigator
Consultant Oncologist
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 Julie Dawson 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 0 inclusion and 1 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 8 Oct 2020. 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?
Specificity & Sensitivity of RCM in diagnosing BCC compared to standard histology (time frame: 18 months). 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 NCT03331874, which also lists 12 linked publications.
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 8 Oct 2020; AzTrials last refreshed its copy on 6 Nov 2026.