Skin CancerNCT03497455
Utility of Digital Dermoscopy in the Skin Cancer Clinic
An observational study of Skin Cancer and Dermatology/Skin - Other, run by Barco NV at 1 site in United Kingdom.
Trial summary
This feasibility study aims to evaluate the use of the BARCO NV digital dermatoscope (non-CE marked device) in the skin cancer clinic. All eligible patients attending the Dermatology outpatient skin cancer clinic will be invited to participate. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer, Dermatology/Skin - Other
- What is being tested?
- Barco NV Digital Dermatoscope device images, Standard medical photographs including dermoscopy images and Clinic proforma completion
- Type of treatment
- Medical device
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jul 2018to 17 Mar 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All eligible \& consenting participants will be approached in a Skin Cancer clinic. Once the clinic consultation has been completed and a decision regarding their management has been made, patients will be invited to consent to the study.
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Patient presenting with any visible skin lesion for Dermatologist review on a body site amenable for optimal photographic imaging
- Able and willing to comply with all study requirements.
- Patient with a skin lesion that is clinically diagnosed by a Consultant Dermatologist as benign OR a suspicious skin lesion requiring excisional biopsy for histological diagnosis
- Patient attending for a 'New' or 'Follow-up' consultation
Who cannot join
- Patients aged under 18 years old
- Patients unable to provide informed consent
- Skin lesions in an anatomical site which is not suitable for photography including genital lesion, hair-bearing site or subungual lesion
- Maximum size of lesion 25 mm
- Lesion is at a site where previous surgery was undertaken
- Lesion on a mucosal site
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7LE
About this study
Official title: Feasibility Study to Evaluate Utility of the BARCO NV Digital Dermatoscope in the Skin Cancer Clinic
This feasibility study aims to evaluate the use of the BARCO NV digital dermatoscope (non-CE marked device) in the skin cancer clinic. All eligible patients attending the Dermatology outpatient skin cancer clinic will be invited to participate. Patients who consent to the study will undergo standard care which will include medical photography of skin lesion(s) and appropriate management as determined by the Consultant Dermatologist in clinic. In addition to standard care, patients will undergo photography of the same lesion(s) using the BARCO NV digital dermatoscope. There will be no other intervention and no additional hospital visits in relation to the study. Use of the device will not influence the clinical management of the patient.
A detailed experience questionnaire will be administered to all clinicians using the BARCO device to explore their opinion on its ease of use and features.
Read more
All standard macroscopic \& dermoscopic images will be taken by OUH medical illustration department and stored on the 'Fotoweb' database (in keeping with current standard practice). Trained Dermatology Consultants, Dermatology Registrars, Research nurses or Medical Photographers, will take BARCO NV device images. A database of all BARCO images will be collected and stored on a dedicated NHS computer separate from the patient clinical record. Standard medical photography images will be stored on Fotoweb as per standard NHS clinical care.
Data will be anonymised and collated and then sent securely to BARCO for further analyses to enable optimization of the BARCO device and for development of diagnostic algorithms in the future.
- Conditions
- Skin Cancer, Dermatology/Skin - Other
- Being tested
- Barco NV Digital Dermatoscope device images, Standard medical photographs including dermoscopy images, Clinic proforma completion
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barco NV Digital Dermatoscope device imagesDevice
Images taken by Clinician in consultation OR in Dermatology department theatres OR images taken in medical photography suite - in the latter case, images can be taken by medical photographer or Research nurse or Dermatologist
Standard medical photographs including dermoscopy imagesDevice
Images taken by medical photographer as part of standard care in the medical photography suite.
Clinic proforma completionOther
This is part of standard care and will be undertaken by the clinician who is responsible for the patient
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician experience questionnaire results
To assess the acceptability of the new dermoscope in the skin cancer clinic, questions about the usability of the device and about the image quality of the obtained dermoscopic pictures are included.
Measured: 1 year
Secondary outcomes (2)
Collection of image database
Anonymised database of clinicopathological and digital images of benign, malignant and equivocal skin lesions + Proportion of high quality images amenable to clinician evaluation
Measured: 1 year
Safety of the device for the patient and the user: occurrence of adverse events
Number of adverse events reported
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start12 Jul 2018
- Primary completion17 Mar 2020
- Study completion17 Mar 2020
Why it stopped: COVID pandemic / Change in strategic direction
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barco NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497455
- Sponsor's protocol ID
- 234237
- Status last verified
- Dec 2021
- First submitted
- 5 Apr 2018
- Last updated
- 29 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study to Evaluate Utility of the BARCO NV Digital Dermatoscope in the Skin Cancer Clinic
- ClinicalTrials.gov ID
- NCT03497455
- Acronym / sponsor ID
- 234237
- Conditions
- Skin Cancer, Dermatology/Skin - Other
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID pandemic / Change in strategic direction
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Barco NVIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 13 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.
This feasibility study aims to evaluate the use of the BARCO NV digital dermatoscope (non-CE marked device) in the skin cancer clinic. All eligible patients attending the Dermatology outpatient skin cancer clinic will be invited to participate. Patients who consent to the study will undergo standard care which will include medical photography of skin lesion(s) and appropriate management as determined by the Consultant Dermatologist in clinic. In addition to standard care, patients will undergo photography of the same lesion(s) using the BARCO NV digital dermatoscope. There will be no other intervention and no additional hospital visits in relation to the study. Use of the device will not influence the clinical management of the patient.
A detailed experience questionnaire will be administered to all clinicians using the BARCO device to explore their opinion on its ease of use and features.
All standard macroscopic \& dermoscopic images will be taken by OUH medical illustration department and stored on the 'Fotoweb' database (in keeping with current standard practice). Trained Dermatology Consultants, Dermatology Registrars, Research nurses or Medical Photographers, will take BARCO NV device images. A database of all BARCO images will be collected and stored on a dedicated NHS computer separate from the patient clinical record. Standard medical photography images will be stored on Fotoweb as per standard NHS clinical care.
Data will be anonymised and collated and then sent securely to BARCO for further analyses to enable optimization of the BARCO device and for development of diagnostic algorithms in the future.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible \& consenting participants will be approached in a Skin Cancer clinic. Once the clinic consultation has been completed and a decision regarding their management has been made, patients will be invited to consent to the study.
Key inclusion criteria (6 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Patient presenting with any visible skin lesion for Dermatologist review on a body site amenable for optimal photographic imaging
- Able and willing to comply with all study requirements.
- Patient with a skin lesion that is clinically diagnosed by a Consultant Dermatologist as benign OR a suspicious skin lesion requiring excisional biopsy for histological diagnosis
Key exclusion criteria (6 listed)
- Patients aged under 18 years old
- Patients unable to provide informed consent
- Skin lesions in an anatomical site which is not suitable for photography including genital lesion, hair-bearing site or subungual lesion
- Maximum size of lesion 25 mm
- Lesion is at a site where previous surgery was undertaken
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 |
|---|---|---|
| Barco NV Digital Dermatoscope device imagesImages taken by Clinician in consultation OR in Dermatology department theatres OR images taken in medical photography suite - in the latter case, images can be taken by medical photographer or Research nurse or Dermatologist | Device | – |
| Standard medical photographs including dermoscopy imagesImages taken by medical photographer as part of standard care in the medical photography suite. | Device | – |
| Clinic proforma completionThis is part of standard care and will be undertaken by the clinician who is responsible for the patient | Other | – |
Primary outcome
Clinician experience questionnaire results
Time frame: 1 year
To assess the acceptability of the new dermoscope in the skin cancer clinic, questions about the usability of the device and about the image quality of the obtained dermoscopic pictures are included.
2 secondary outcomes
Collection of image database
Time frame: 1 year
Safety of the device for the patient and the user: occurrence of adverse events
Time frame: 1 year
Results and safety
The study was stopped early (reason given: COVID pandemic / Change in strategic direction). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Skin Cancer and Dermatology/Skin - Other, run by Barco NV 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 6 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: stopped early, as of the sponsor's last update on 29 Dec 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 was stopped early (reason given: COVID pandemic / Change in strategic direction). Results are not available in the source record.
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?
Clinician experience questionnaire results (time frame: 1 year). 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 29 Dec 2021.