Common Melanocytic NeviNCT01194947
Classification and Longitudinal Follow-up of Common Melanocytic Nevi With in Vivo Reflectance Confocal Microscopy
An observational study of Common Melanocytic Nevi, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Our working hypothesis is that reflectance confocal microscopy (RCM) can identify distinct subsets of melanocytic nevi that retain their distinctive pattern over time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Common Melanocytic Nevi
- What is being tested?
- RCM imaging
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2010to Sep 2013
- 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
- No healthy volunteers
- Adult, Older adult
Study population: patients visiting the pigmented lesion clinic for skin cancer surveillance
Who may be able to join
- Patients visiting the Sheba Medical Center pigmented lesion clinic for skin examination
- Patients having at least three banal-appearing nevi, one on the upper back, one on the lower back and one on the lower extremity (excluding foot), which are amenable for RCM examination.
Who cannot join
- Patients who are unwilling or medically unable to lie down for 30 minutes.
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sheba Medical Center
Rmat-gan, 52621
ALON SCOPE, MD, 972-3-5302443
ALON SCOPE, MD
About this study
Our working hypothesis is that reflectance confocal microscopy (RCM) can identify distinct subsets of melanocytic nevi that retain their distinctive pattern over time.
- Conditions
- Common Melanocytic Nevi
- Being tested
- RCM imaging
- Keywords
- banal-appearing nevi, NEVUS
- Medical subject headings
- Nevus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RCM imagingDevice
RCM imaging will be performed using a commercially-available RCM (Vivascope 1500, Lucid Inc, Rochester, NY, USA) with 830-nm diode laser with emitting power less than 35 milliwatts
| Study group | Role | What they receive |
|---|---|---|
| Study participants | patients 18 or older presenting to the Sheba Medical Center pigmented lesion clinic for skin cancer surveillance. Patients routinely undergo total skin examination that includes clinical and dermoscopic evaluation of skin lesions. Patients also routinely undergo annual total body digital photography that allows identification of new or changing lesions. Receives: Device: RCM imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-rater agreement on assignment of nevi to RCM patterns (baseline and follow-up images).
Measured: 3 YEARS
Secondary outcomes (1)
Description of rates of retention and change in RCM pattern of nevi during follow-up
Measured: 3 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Melanocytic NeviStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- ALON SCOPE, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01194947
- Sponsor's protocol ID
- SHEBA-10-8015-AS-CTIL
- Status last verified
- Sep 2010
- First submitted
- 2 Sep 2010
- Last updated
- 3 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Classification and Longitudinal Follow-up of Common Melanocytic Nevi With in Vivo Reflectance Confocal Microscopy
- ClinicalTrials.gov ID
- NCT01194947
- Acronym / sponsor ID
- SHEBA-10-8015-AS-CTIL
- Conditions
- Common Melanocytic Nevi
- Keywords
- banal-appearing nevi, NEVUS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Sep 2010
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 3 Sep 2010 (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.
Our working hypothesis is that reflectance confocal microscopy (RCM) can identify distinct subsets of melanocytic nevi that retain their distinctive pattern over time.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study participants | – | Device: RCM imagingpatients 18 or older presenting to the Sheba Medical Center pigmented lesion clinic for skin cancer surveillance. Patients routinely undergo total skin examination that includes clinical and dermoscopic evaluation of skin lesions. Patients also routinely undergo annual total body digital photography that allows identification of new or changing lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients visiting the pigmented lesion clinic for skin cancer surveillance
Key inclusion criteria (2 listed)
- Patients visiting the Sheba Medical Center pigmented lesion clinic for skin examination
- Patients having at least three banal-appearing nevi, one on the upper back, one on the lower back and one on the lower extremity (excluding foot), which are amenable for RCM examination.
Key exclusion criteria (2 listed)
- Patients who are unwilling or medically unable to lie down for 30 minutes.
- 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 |
|---|---|---|
| RCM imagingRCM imaging will be performed using a commercially-available RCM (Vivascope 1500, Lucid Inc, Rochester, NY, USA) with 830-nm diode laser with emitting power less than 35 milliwatts | Device | Study participants |
Primary outcome
Inter-rater agreement on assignment of nevi to RCM patterns (baseline and follow-up images).
Time frame: 3 YEARS
1 secondary outcome
Description of rates of retention and change in RCM pattern of nevi during follow-up
Time frame: 3 YEARS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2010.
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.
ALON SCOPE, MD principal investigator
Sheba Medical Center
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 Common Melanocytic Nevi, run by Sheba Medical Center at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 3 Sep 2010. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ALON SCOPE, MD (972-3-5302443, scopea1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-rater agreement on assignment of nevi to RCM patterns (baseline and follow-up images). (time frame: 3 YEARS). 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 3 Sep 2010.