Skin LesionOMS002_UKNCT03109327
Investigating the Clinical Utility of the MDS
An observational study of Skin Lesion and Melanoma, run by Orlucent, Inc at 1 site in United Kingdom.
Trial summary
The purpose of this study is to establish the clinical utility of the Melanoma Detection System (MDS). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Skin Lesion, Melanoma, Moles
- What is being tested?
- Melanoma Detection System -MDS
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2018to 30 Oct 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects referred to a specialist for possible presence of melanoma in skin lesions.
Who may be able to join
- Lesion has one or more of the ABCDE features and is recommended for excision.
- Lesion has at least 1 cm of skin around it that is accessible to the MDS.
- Patient is at least 18 years old.
- Patient is capable of giving written informed consent.
- Lesion is scheduled for primary excision.
Who cannot join
- Lesion is less than one centimetre from the eyes.
- Lesion is on the palms of the hands or soles of the feet.
- Lesion is mucosal.
- Lesion is ulcerated.
- Patient is pregnant.
- Low patient study procedure compliance.
Show all 11Show fewer
- Patient who is mentally or physically unable to comply with all aspects of the study.
- Patient is undergoing chemotherapy.
- Patient has known sensitivity to fluorescent dyes.
- Ink marking on or adjacent to lesion.
- Lesions larger than 20mm or too large to allow imaging.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NHS Lanarkshire, Monklands Hospital
Airdrie, ML60JS
About this study
Official title: Investigating the Clinical Utility of the MDS Test for the Oncogenic Activity in Nevi Suspected of Being Melanoma
The purpose of this study is to establish the clinical utility of the Melanoma Detection System (MDS).
Read the detailed description
The purpose of this study is to establish the clinical utility of the MDS while continuing to evaluate the safety and performance of the MDS in patients with skin lesions who are referred to secondary care clinics for evaluation, whose lesions (moles) are suspicious for melanoma.
- Conditions
- Skin Lesion, Melanoma, Moles
- Being tested
- Melanoma Detection System -MDS
- Medical subject headings
- Melanoma, Nevus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melanoma Detection System -MDSDiagnostic test
Also called MDS
Imaging of lesion using the MDS test.
| Study group | Role | What they receive |
|---|---|---|
| Urgent Excision | Subjects with moles suspicious of melanoma and are scheduled for an urgent excision. Receives: Diagnostic Test: Melanoma Detection System -MDS | |
| Non-urgent Excision | Subjects with moles not-suspicious of melanoma and are scheduled for a non urgent excision. Receives: Diagnostic Test: Melanoma Detection System -MDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utility of the MDS in determining urgent or non-urgent excision of moles.
The MDS will provide a score that reflects the possibility for the presence of melanoma in moles. The score will be used together with clinical evaluation.
Measured: 1 day
Secondary outcomes (1)
Does the MDS have an additive value to clinical evaluation of moles.
Does the MDS system provide superior results when compared to clinical evaluation.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start1 Apr 2018
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LesionStudies 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orlucent, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NHS Lanarkshire, NHS Tayside, NHS Greater Glasgow and Clyde, University Hospitals, Leicester, University of Dundee
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109327
- Sponsor's protocol ID
- OMS002_UK
- Acronym
- OMS002_UK
- Status last verified
- Nov 2020
- First submitted
- 8 Mar 2017
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Clinical Utility of the MDS Test for the Oncogenic Activity in Nevi Suspected of Being Melanoma
- ClinicalTrials.gov ID
- NCT03109327
- Acronym / sponsor ID
- OMS002_UK / OMS002_UK
- Conditions
- Skin Lesion, Melanoma, Moles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Orlucent, IncIndustry (pharma, biotech, devices)
- Collaborators
- NHS Lanarkshire, NHS Tayside, NHS Greater Glasgow and Clyde, University Hospitals, Leicester, University of Dundee
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 12 Apr 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.
The purpose of this study is to establish the clinical utility of the Melanoma Detection System (MDS).
Detailed description
The purpose of this study is to establish the clinical utility of the MDS while continuing to evaluate the safety and performance of the MDS in patients with skin lesions who are referred to secondary care clinics for evaluation, whose lesions (moles) are suspicious for melanoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urgent Excision | – | Diagnostic Test: Melanoma Detection System -MDSSubjects with moles suspicious of melanoma and are scheduled for an urgent excision. |
| Non-urgent Excision | – | Diagnostic Test: Melanoma Detection System -MDSSubjects with moles not-suspicious of melanoma and are scheduled for a non urgent excision. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects referred to a specialist for possible presence of melanoma in skin lesions.
Key inclusion criteria (5 listed)
- Lesion has one or more of the ABCDE features and is recommended for excision.
- Lesion has at least 1 cm of skin around it that is accessible to the MDS.
- Patient is at least 18 years old.
- Patient is capable of giving written informed consent.
- Lesion is scheduled for primary excision.
Key exclusion criteria (11 listed)
- Lesion is less than one centimetre from the eyes.
- Lesion is on the palms of the hands or soles of the feet.
- Lesion is mucosal.
- Lesion is ulcerated.
- Patient is pregnant.
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 |
|---|---|---|
| Melanoma Detection System -MDSAlso: MDSImaging of lesion using the MDS test. | Diagnostic test | Non-urgent Excision, Urgent Excision |
Primary outcome
Utility of the MDS in determining urgent or non-urgent excision of moles.
Time frame: 1 day
The MDS will provide a score that reflects the possibility for the presence of melanoma in moles. The score will be used together with clinical evaluation.
1 secondary outcome
Does the MDS have an additive value to clinical evaluation of moles.
Time frame: 1 day
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 19 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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 Lesion and Melanoma, run by Orlucent, Inc 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 5 inclusion and 11 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 19 Nov 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?
Utility of the MDS in determining urgent or non-urgent excision of moles. (time frame: 1 day). 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 19 Nov 2020.