Skin LesionsNCT02056522
Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging
An observational study of Skin Lesions, run by Orlucent, Inc at 2 sites in Israel.
Trial summary
The use of MDS to access the presence of melanoma in the skin. Read more about this study
- Who is it for?
- Ages 21 to 97 years
- Conditions the study is for
- Skin Lesions
- How many people
- 357 participants
- Where
- 2 sitesIsrael
- Study dates
- Jul 2016to Jul 2018
- 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 21 to 97 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individual referred by a dermatologist or plastic surgeon for a skin biopsy or lesion excision.
Who may be able to join
- Individuals with skin lesion with one or more of the ABCDE features and recommended for a skin biopsy.
- The lesion is accessible to the imaging device, with at least 1 cm of skin around the lesion that is accessible to the MDS.
- Male and female ≥ 21 years old.
- Subject is capable of giving written informed consent.
- Primary excision.
Who cannot join
- The lesion is less than 1 cm from the eyes.
- The lesion is on the palms of hands or soles of the feet.
- Mucosal lesion.
- Pregnant females.
- Low study procedure compliance.
- Patients who are mentally or physically unable to comply with all aspects of the study.
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- Undergoing chemotherapy.
- Minor or legally incompetent and not able to sign the consent form.
- Patient previously tested by MDS and was diagnosed with melanoma during the study.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Clalit Health Services
Kiryat Bialik
Ziv Medical Center
Safed, 13100
About this study
Official title: Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging: the MDS (Melanoma Detecting System)
The use of MDS to access the presence of melanoma in the skin.
Read the detailed description
A topical agent is applied to suspicious skin lesions and imaged. The images are analyzed to provide a score that correlates with the probability for the presence of melanoma in the lesion.
- Conditions
- Skin Lesions
- Keywords
- Melanoma, Skin Cancer
- Medical subject headings
- Melanoma, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Suspicious skin lesions. | No intervention is administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate the performance of MDS
Measured: 28 days
Secondary outcomes (1)
To calculate and specify the PPV and NPV of the MDS for melanoma detection when used as an adjacent tool to visual skin examination.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study startJul 2016
- Primary completionApr 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LesionsStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orlucent, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shokrey Kassis, MA, Principal investigator, Head of Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056522
- Sponsor's protocol ID
- OMS 001
- Status last verified
- Feb 2018
- First submitted
- 15 Dec 2013
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging: the MDS (Melanoma Detecting System)
- ClinicalTrials.gov ID
- NCT02056522
- Acronym / sponsor ID
- OMS 001
- Conditions
- Skin Lesions
- Keywords
- Melanoma, Skin Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- Orlucent, IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 6 Feb 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.
The use of MDS to access the presence of melanoma in the skin.
Detailed description
A topical agent is applied to suspicious skin lesions and imaged. The images are analyzed to provide a score that correlates with the probability for the presence of melanoma in the lesion.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspicious skin lesions. | – | –No intervention is administered. |
Who may qualify
- Ages
- 21 to 97 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individual referred by a dermatologist or plastic surgeon for a skin biopsy or lesion excision.
Key inclusion criteria (5 listed)
- Individuals with skin lesion with one or more of the ABCDE features and recommended for a skin biopsy.
- The lesion is accessible to the imaging device, with at least 1 cm of skin around the lesion that is accessible to the MDS.
- Male and female ≥ 21 years old.
- Subject is capable of giving written informed consent.
- Primary excision.
Key exclusion criteria (9 listed)
- The lesion is less than 1 cm from the eyes.
- The lesion is on the palms of hands or soles of the feet.
- Mucosal lesion.
- Pregnant females.
- Low study procedure compliance.
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
To validate the performance of MDS
Time frame: 28 days
1 secondary outcome
To calculate and specify the PPV and NPV of the MDS for melanoma detection when used as an adjacent tool to visual skin examination.
Time frame: 28 days
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 18 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.
Shokrey Kassis, MA principal investigator
Head of Plastic Surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Lesions, run by Orlucent, Inc at 2 sites in Israel.
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 9 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 18 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 2 sites in Israel. 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?
To validate the performance of MDS (time frame: 28 days). 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 18 Nov 2020.