Skin LesionsNCT02009085
Pilot Study to Determine Feasibility of Benign and Malignant Skin Lesion Detection.
An observational study of Skin Lesions, run by Orlucent, Inc.
Trial summary
In this study a fluorescent contrast dye is applied to a suspicious skin lesion. Images are acquired and processed. The information is used to develop a prediction model for the presence of malignant transformation in the skin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Lesions
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients above 18 years scheduled for a skin biopsy.
Who may be able to join
- Over the age of 18
- Individual is scheduled for a skin biopsy in toto
- The lesion is pigmented or non pigmented
- Lesions may be under suspicion for basal cell carcinoma, squamous cell carcinoma, actinic keratosis, nevi, melanoma, seborrheic keratosis.
- The lesion is accessible to the imaging device
Who cannot join
- The patient has sensitive skin and easily breaks out in rash
- The lesion is within 1 cm of the eye
- The lesion is on mucosal surfaces (e.g., lips, genitals)
- Pregnant females
- Taking medications that pigments the skin
About this study
Official title: Pilot Study to Asses the Identification of Melanoma in Skin Lesions.
In this study a fluorescent contrast dye is applied to a suspicious skin lesion.
Images are acquired and processed. The information is used to develop a prediction model for the presence of malignant transformation in the skin.
Read the detailed description
Images acquired in the study are used for the development of a software analysis program.
- Conditions
- Skin Lesions
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 |
|---|---|---|
| Individuals undergoing skin excision. | Skin lesions are under suspicion for skin cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between imaging and pathology.
Patients are imaged and then undergo a biopsy. Images are used to develop a software predicting model based on pathology. Sensitivity and specificity parameters are calculated.
No long term follow up is required since the biopsy is performed on the skin imaged. The follow up required is for the pathology for the skin excised.
Measured: No long term follow up is necessary.
Secondary outcomes (1)
Acute response
The acute dermal response to the imaging procedure is evaluated.
Measured: up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2017
- Study completionJun 2017
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
- Retrospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orlucent, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clalit Health Services
- Responsible party
- Sponsor
- Investigators
- Yehuda Ullmann, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009085
- Sponsor's protocol ID
- KH 2012
- Status last verified
- Feb 2018
- First submitted
- 25 Nov 2013
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Asses the Identification of Melanoma in Skin Lesions.
- ClinicalTrials.gov ID
- NCT02009085
- Acronym / sponsor ID
- KH 2012
- Conditions
- Skin Lesions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Orlucent, IncIndustry (pharma, biotech, devices)
- Collaborators
- Clalit Health Services
- Study start
- Jun 2013
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 11 Dec 2013 (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.
In this study a fluorescent contrast dye is applied to a suspicious skin lesion.
Images are acquired and processed. The information is used to develop a prediction model for the presence of malignant transformation in the skin.
Detailed description
Images acquired in the study are used for the development of a software analysis program.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals undergoing skin excision. | – | –Skin lesions are under suspicion for skin cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients above 18 years scheduled for a skin biopsy.
Key inclusion criteria (5 listed)
- Over the age of 18
- Individual is scheduled for a skin biopsy in toto
- The lesion is pigmented or non pigmented
- Lesions may be under suspicion for basal cell carcinoma, squamous cell carcinoma, actinic keratosis, nevi, melanoma, seborrheic keratosis.
- The lesion is accessible to the imaging device
Key exclusion criteria (5 listed)
- The patient has sensitive skin and easily breaks out in rash
- The lesion is within 1 cm of the eye
- The lesion is on mucosal surfaces (e.g., lips, genitals)
- Pregnant females
- Taking medications that pigments the skin
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
Correlation between imaging and pathology.
Time frame: No long term follow up is necessary.
Patients are imaged and then undergo a biopsy. Images are used to develop a software predicting model based on pathology. Sensitivity and specificity parameters are calculated. No long term follow up is required since the biopsy is performed on the skin imaged. The follow up required is for the pathology for the skin excised.
1 secondary outcome
Acute response
Time frame: up to 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 Feb 2018.
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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.
Yehuda Ullmann, MD principal investigator
Rambam Health Care Campus
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Lesions, run by Orlucent, Inc.
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 5 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 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Correlation between imaging and pathology. (time frame: No long term follow up is necessary.). 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 Feb 2018.