Melanocytic NevusNCT02473874
Comparison Imaging System Between Spatially Modulated Quantitative Spectroscopy and Skin Spect Dermoscopy
An observational study of Melanocytic Nevus, run by University of California, Irvine at 1 site in United States.
Trial summary
The purpose of this study is to obtain skin spectroscopic data from two imaging systems. Comparison groups: Skin Spect dermoscope Spatially modulated quantitative spectrometer Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melanocytic Nevus
- What is being tested?
- Skin Spect dermoscope and Spatially modulated quantitative
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jan 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: Subjects will be recruited from an outpatient population of subjects at Beckman Laser Medical Clinic, University of California, Irvine.
Who may be able to join
- Skin lesion a mole located on flat surface of the body
Who cannot join
- Mole located on complex surface
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spectral Comparison Between Spatially Modulated Quantitative Spectroscopy and Polarization-Sensitive Hyperspectral Multimode Dermoscopy for the Purpose of Skin Compositional Analysis
The purpose of this study is to obtain skin spectroscopic data from two imaging systems.
Comparison groups:
- Skin Spect dermoscope
- Spatially modulated quantitative spectrometer
Read the detailed description
The researcher can compare the spectroscopic data from the two systems as well as the relative concentrations of melanin, oxy- and deoxy- hemoglobin calculated from the measurements.
Skin Spect can measure larger area of skin, whereas Spatially modulated quantitative spectrometer is a point-based measurement.Therefore, larger nevi will require multiple Spatially modulated quantitative spectrometer measurements for comparison with corresponding sub-regions of the larger Skin Spect measurements. Only sub-regions of the image data from Skin Spect that match the locations Spatially modulated quantitative spectrometer acquired data will be used in this correlation study.
This researcher ensure that the spectral data collected by the two instruments are collected from the same spatial locations, should lesion heterogeneity be present.
- Conditions
- Melanocytic Nevus
- Being tested
- Skin Spect dermoscope, Spatially modulated quantitative
- Medical subject headings
- Nevus, Pigmented
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Spect dermoscopeDevice
Skin imaging
Spatially modulated quantitativeDevice
Skin imaging
| Study group | Role | What they receive |
|---|---|---|
| Skin Spect dermoscope | Skin mole Receives: Device: Skin Spect dermoscope | |
| Spatially modulated quantitative | Skin mole Receives: Device: Spatially modulated quantitative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in human skin structure
Comparison Imaging Changes in human skin structure Between Spatially Modulated Quantitative Spectroscopy and Skin Spect Dermoscopy
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2020
- Study completionJan 2020
Why it stopped: Not NIH defined clinical trial study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanocytic NevusStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- Kristen Kelly, MD, Principal investigator, Beckman Laser Institute, UCI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473874
- Sponsor's protocol ID
- 20151791
- Status last verified
- Oct 2022
- First submitted
- 5 Jun 2015
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectral Comparison Between Spatially Modulated Quantitative Spectroscopy and Polarization-Sensitive Hyperspectral Multimode Dermoscopy for the Purpose of Skin Compositional Analysis
- ClinicalTrials.gov ID
- NCT02473874
- Acronym / sponsor ID
- 20151791
- Conditions
- Melanocytic Nevus
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Not NIH defined clinical trial study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Study start
- Jun 2015
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 17 Jun 2015 (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 purpose of this study is to obtain skin spectroscopic data from two imaging systems.
Comparison groups:
- Skin Spect dermoscope
- Spatially modulated quantitative spectrometer
Detailed description
The researcher can compare the spectroscopic data from the two systems as well as the relative concentrations of melanin, oxy- and deoxy- hemoglobin calculated from the measurements.
Skin Spect can measure larger area of skin, whereas Spatially modulated quantitative spectrometer is a point-based measurement.Therefore, larger nevi will require multiple Spatially modulated quantitative spectrometer measurements for comparison with corresponding sub-regions of the larger Skin Spect measurements. Only sub-regions of the image data from Skin Spect that match the locations Spatially modulated quantitative spectrometer acquired data will be used in this correlation study.
This researcher ensure that the spectral data collected by the two instruments are collected from the same spatial locations, should lesion heterogeneity be present.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin Spect dermoscope | – | Device: Skin Spect dermoscopeSkin mole |
| Spatially modulated quantitative | – | Device: Spatially modulated quantitativeSkin mole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from an outpatient population of subjects at Beckman Laser Medical Clinic, University of California, Irvine.
Key inclusion criteria (1 listed)
- Skin lesion a mole located on flat surface of the body
Key exclusion criteria (2 listed)
- Mole located on complex surface
- Pregnant women
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 |
|---|---|---|
| Skin Spect dermoscopeSkin imaging | Device | Skin Spect dermoscope |
| Spatially modulated quantitativeSkin imaging | Device | Spatially modulated quantitative |
Primary outcome
Changes in human skin structure
Time frame: up to 12 weeks
Comparison Imaging Changes in human skin structure Between Spatially Modulated Quantitative Spectroscopy and Skin Spect Dermoscopy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
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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.
Kristen Kelly, MD principal investigator
Beckman Laser Institute, UCI
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 Melanocytic Nevus, run by University of California, Irvine at 1 site in United States.
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 2 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: withdrawn, as of the sponsor's last update on 1 Nov 2022. 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 States. 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 withdrawn before enrolling participants, so there are no results.
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?
Changes in human skin structure (time frame: up to 12 weeks). 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 1 Nov 2022.