MelanomaNCT02196246
Moletest Clinical Study in Scotland
An observational study of Melanoma, run by Moletest Scotland Ltd at 1 site in United Kingdom.
Trial summary
To evaluate an iPad based photoimage analysis system (Moletest) for improving discrimination of benign from malignant suspicious skin lesions or moles. Specifically the objective is to demonstrate that the Moletest system is able with a sufficient degree of confidence (95%) to identify lesions which are benign Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Melanoma
- How many people
- 1,120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Mar 2015to 31 May 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients referred to the Dermatology Department, Lanarkshire Hospitals for assessment of suspicious skin lesions are eligible for inclusion
Who may be able to join
- All patients referred to the Dermatology Department, Lanarkshire Hospitals during a period to be defined for assessment of suspicious skin lesions (cutaneous moles) will be eligible for inclusion in the study. There are no age limits but patients under the age of 18 years will also have their inclusion subject to parental/guardian consent
Who cannot join
- There is no exclsion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study to Evaluate the Ability of an iPad Based Photographic Image Analysis System to Discriminate Benign Skin Lesions From Those Considered Suspect for Melanoma
To evaluate an iPad based photoimage analysis system (Moletest) for improving discrimination of benign from malignant suspicious skin lesions or moles. Specifically the objective is to demonstrate that the Moletest system is able with a sufficient degree of confidence (95%) to identify lesions which are benign
- Conditions
- Melanoma
- Medical subject headings
- Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical accuracy of Moletest application, the combined measured attributes of a suspect legion compared to the outcome of a biopsy performed on the legion
The image and analysis by the application are performed within 10 minutes of the patient giving consent to be part of this study. The biopsy that will be used for comarison with the image analysis will be available to the Investigators approximatly 6 weeks later
Measured: 6 weeks turnaround for each sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study start27 Mar 2015
- Primary completion12 Oct 2016
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moletest Scotland Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Digital Health & Care Institute, NHS Lanarkshire
- Responsible party
- Principal investigator, Girish Gupta, Moletest Scotland Ltd
- Investigators
- Peter Freedman, Study director, Royal College of Physicians
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196246
- Sponsor's protocol ID
- Protocol-004
- Status last verified
- Dec 2017
- First submitted
- 17 Jul 2014
- Last updated
- 4 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Ability of an iPad Based Photographic Image Analysis System to Discriminate Benign Skin Lesions From Those Considered Suspect for Melanoma
- ClinicalTrials.gov ID
- NCT02196246
- Acronym / sponsor ID
- Protocol-004
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,120 participants (actual)
- Lead sponsor
- Moletest Scotland LtdIndustry (pharma, biotech, devices)
- Collaborators
- Digital Health & Care Institute, NHS Lanarkshire
- Study start
- 27 Mar 2015 (actual)
- Primary completion
- 12 Oct 2016 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 22 Jul 2014 (estimated)
- 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.
To evaluate an iPad based photoimage analysis system (Moletest) for improving discrimination of benign from malignant suspicious skin lesions or moles. Specifically the objective is to demonstrate that the Moletest system is able with a sufficient degree of confidence (95%) to identify lesions which are benign
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients referred to the Dermatology Department, Lanarkshire Hospitals for assessment of suspicious skin lesions are eligible for inclusion
Key inclusion criteria (1 listed)
- All patients referred to the Dermatology Department, Lanarkshire Hospitals during a period to be defined for assessment of suspicious skin lesions (cutaneous moles) will be eligible for inclusion in the study. There are no age limits but patients under the age of 18 years will also have their inclusion subject to parental/guardian consent
Key exclusion criteria (1 listed)
- There is no exclsion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical accuracy of Moletest application, the combined measured attributes of a suspect legion compared to the outcome of a biopsy performed on the legion
Time frame: 6 weeks turnaround for each sample
The image and analysis by the application are performed within 10 minutes of the patient giving consent to be part of this study. The biopsy that will be used for comarison with the image analysis will be available to the Investigators approximatly 6 weeks later
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 4 Dec 2017.
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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.
Peter Freedman study director
Royal College of Physicians
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, run by Moletest Scotland 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 1 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 4 Dec 2017. 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?
Clinical accuracy of Moletest application, the combined measured attributes of a suspect legion compared to the outcome of a biopsy performed on the legion (time frame: 6 weeks turnaround for each sample). 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 4 Dec 2017.