Melanoma (Skin)NCT03508297
Reflectance Confocal Microscopy to Diagnose MM & LM
An observational study of Melanoma (Skin) and Lentigo Maligna, run by Skin Care Network Ltd. at 1 site in United Kingdom.
Trial summary
A reflectance confocal microscope is a machine which is able to examine the upper layers of the skin painlessly and without the need for taking a biopsy. We would like to examine the images taken by the confocal microscope to see if it can help more accurately identify lesions which are worrying rather than a benign… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin), Lentigo Maligna
- What is being tested?
- In-vivo imaging
- How many people
- 597 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Mar 2017to 31 Aug 2020
- 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 LM or MM.
Who may be able to join
- Age 18 years or older
- Patient with a pigmented lesion recommended for excision because of suspicion of MM or LM.
- Patient willing and able to give informed consent
Who cannot join
- Recurrent MM or LM
- Patient on immunosuppresants
- Patient with significant co-morbidity or skin disease
- Patient not suitable for diagnostic biopsy
- Location of lesion unsuitable, inaccessible or impractical for scanning with RCM as determined by investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reflectance Confocal Microscopy to Diagnose Malignant Melanoma and Lentigo Maligna
A reflectance confocal microscope is a machine which is able to examine the upper layers of the skin painlessly and without the need for taking a biopsy. We would like to examine the images taken by the confocal microscope to see if it can help more accurately identify lesions which are worrying rather than a benign mole. We are performing this study in patients in whom we have recommended excising a mole to exclude a cancer. If the results of the study show that the confocal microscope can help more accurately diagnose Melanomas then this would reduce the number of biopsies that are taken that turn out not to be cancerous (ie unnecessary biopsies).
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 MM and LM.
Study Endpoints The hypothesis of this study is that the use of RCM is would reduce the NNE prior to definitive treatment by at least 30% from the current value of approximately 10.
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).
Setting and recruitment Patients will be recruited from the outpatient clinics of the Skin Care Network Barnet, and from the outpatient clinics of the Chase Farm and Barnet sites of Royal Free Hospital NHS Foundation Trust.
Participants The number of true negative lesions examined in this study will be 654. It is anticipated that this will result in a total of 661 lesions being recruited. 10% of participants are expected to have more than one lesion sampled.
The result of biopsy for each lesion will not be known until after the lesion has been included in the study. Therefore lesions will be added to the study until the required number of true negatives has been included.
- Conditions
- Melanoma (Skin), Lentigo Maligna
- Being tested
- In-vivo imaging
- Keywords
- Confocal, RCM, Imaging, Skin cancer
- Medical subject headings
- Melanoma, Hutchinson's Melanotic Freckle, 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.
Number Needed to Excise
The number of suspicious lesions (defined by conventional histology) biopsied to find one cancerous lesion
Measured: During exam (biopsy results typically available within one week).
Secondary outcomes (1)
intra- & inter-observer agreement for interpreting the RCM images will have kappa scores 0.6 or greater
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 posted25 Apr 2018
- Study start14 Mar 2017
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
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 Melanoma (Skin)Studies 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
- 597 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
- NCT03508297
- Sponsor's protocol ID
- HS-MAV-002
- Status last verified
- Nov 2021
- First submitted
- 16 Apr 2018
- Last updated
- 12 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stevens HP, Pellacani G, Angus C, El-Jabbour JN. Reflectance confocal microscopy to diagnose malignant melanoma and lentigo maligna in the UK: a single-centre prospective observational trial. Br J Dermatol. 2024 Dec 23;192(1):27-35. doi: 10.1093/bjd/ljae354.
PubMed 39255055
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reflectance Confocal Microscopy to Diagnose Malignant Melanoma and Lentigo Maligna
- ClinicalTrials.gov ID
- NCT03508297
- Acronym / sponsor ID
- HS-MAV-002
- Conditions
- Melanoma (Skin), Lentigo Maligna
- Keywords
- Confocal, RCM, Imaging, Skin cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 597 participants (actual)
- Lead sponsor
- Skin Care Network Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 25 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.
A reflectance confocal microscope is a machine which is able to examine the upper layers of the skin painlessly and without the need for taking a biopsy. We would like to examine the images taken by the confocal microscope to see if it can help more accurately identify lesions which are worrying rather than a benign mole. We are performing this study in patients in whom we have recommended excising a mole to exclude a cancer. If the results of the study show that the confocal microscope can help more accurately diagnose Melanomas then this would reduce the number of biopsies that are taken that turn out not to be cancerous (ie unnecessary biopsies).
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 MM and LM.
Study Endpoints The hypothesis of this study is that the use of RCM is would reduce the NNE prior to definitive treatment by at least 30% from the current value of approximately 10.
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).
Setting and recruitment Patients will be recruited from the outpatient clinics of the Skin Care Network Barnet, and from the outpatient clinics of the Chase Farm and Barnet sites of Royal Free Hospital NHS Foundation Trust.
Participants The number of true negative lesions examined in this study will be 654. It is anticipated that this will result in a total of 661 lesions being recruited. 10% of participants are expected to have more than one lesion sampled.
The result of biopsy for each lesion will not be known until after the lesion has been included in the study. Therefore lesions will be added to the study until the required number of true negatives has been included.
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 LM or MM.
Key inclusion criteria (3 listed)
- Age 18 years or older
- Patient with a pigmented lesion recommended for excision because of suspicion of MM or LM.
- Patient willing and able to give informed consent
Key exclusion criteria (5 listed)
- Recurrent MM or LM
- Patient on immunosuppresants
- Patient with significant co-morbidity or skin disease
- 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
Number Needed to Excise
Time frame: During exam (biopsy results typically available within one week).
The number of suspicious lesions (defined by conventional histology) biopsied to find one cancerous lesion
1 secondary outcome
intra- & inter-observer agreement for interpreting the RCM images will have kappa scores 0.6 or greater
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 12 Nov 2021.
- Derived from this study: PubMed 39255055Stevens HP, Pellacani G, Angus C, El-Jabbour JN. Reflectance confocal microscopy to diagnose malignant melanoma and lentigo maligna in the UK: a single-centre prospective observational trial. Br J Dermatol. 2024 Dec 23;192(1):27-35. doi: 10.1093/bjd/ljae354.
- 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.
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 Melanoma (Skin) and Lentigo Maligna, 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 5 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 12 Nov 2021. 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?
Number Needed to Excise (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 NCT03508297, 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 12 Nov 2021.