Skin CancerNCT00588315
In Vivo Confocal Microscopy of Cutaneous Neoplasms and Normal Skin
An observational study of Skin Cancer, run by Memorial Sloan Kettering Cancer Center at 4 sites in United States.
Trial summary
The purpose of this study is to investigate new non-invasive imaging techniques for the evaluation of skin lesions, as well as normal skin. Our primary goal is to collect and study these images of different skin lesions along with matching biopsy specimens. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer
- How many people
- 1,889 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 1999to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients of the Dermatology, Clinical Immunology Services, Pediatrics and Radiology Oncology departments that are determined to have a skin lesion with anticipated epidermal and superficial dermal histologic alterations amenable to visualization by surface confocal microscopy will be offered the opportunity to participate in the study.
Who may be able to join
- Patients older than or equal to 10 years of age.
- Patients with a skin lesion with anticipated epidermal and superficial dermal histologic alterations amenable to visualization by surface confocal microscopy.
- Healthy volunteer subjects older than or equal to 10 years old.
- Ability to give informed consent.
Who cannot join
- Patients who are allergic to fluorescein sodium.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Memorial Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, 10604
Memorial Sloan Kettering Hauppauge (Consent only)
Hauppauge, New York, 11788
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to investigate new non-invasive imaging techniques for the evaluation of skin lesions, as well as normal skin. Our primary goal is to collect and study these images of different skin lesions along with matching biopsy specimens. The long-term goal is to develop a technique that will improve the early detection of skin cancer and eliminate the need for many skin biopsies.
The High-resolution OCT (Apollo Medical Optics) device can provide both cross-sectional and en-face images with cellular information. Real-time color images through the same objective with OCT are also provided to show the OCT imaging location of lesion. The color image can be registered simultaneously on a larger dermoscopic image obtained by an external dermoscope. The imaging mode of cross-sectional, en-face and color image can be switched arbitrarily to align the lesion and obtain high-resolution images efficiently. The total imaging time is around 10 to 15 minutes depending on the number of images to be obtained.
Read more
To help identify more diagnostic features of optical imaging and better understand their histology correlation, we have developed a novel technique called "precision biopsy". Precision biopsy is an optical imaging guided, feature-targeted mini-biopsy. Once the feature of interest is identified and isolated by the optical imaging, a 2.0 mm punch biopsy is performed. Besides cosmetic benefit of minimal scarring, this tissue sparing biopsy captures the "feature of interest" for histology revelation.
Additionally, the histologic features of precision biopsy will be compared to images gathered by multi-modal optical imaging. The precision biopsy will also be compared to the traditional shave biopsy or shave excision, to determine whether the diagnostic information is comparable between the two methods.
For live remote control (LRC) imaging consultation, MSK dermatologist will based on his clinical examination. An imaging technician will perform the clinical and dermoscopic imaging, while the expert reader will perform confocal imaging remotely via a HIPPA compliant Webex platform.
- Conditions
- Skin Cancer
- Medical subject headings
- 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 |
|---|---|---|
| skin lesions | The integrated dermoscopic-and-confocal microscopic video-mosaics will be used to compare morphologic patterns and cellular patterns to each other and to the corresponding pathology | |
| normal skin | The integrated dermoscopic-and-confocal microscopic video-mosaics will be used to compare morphologic patterns and cellular patterns to each other and to the corresponding pathology |
What is being measured
The primary outcome is the main question the study is designed to answer.
The study is a descriptive one. No formal statistical testing of correlations will be performed.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2008 (estimated)
- Study startNov 1999
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer 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-control
- Time perspective
- Prospective
- Enrolment
- 1,889 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manu Jain, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00588315
- Sponsor's protocol ID
- 99-099
- Status last verified
- Jan 2026
- First submitted
- 24 Dec 2007
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Confocal Microscopy of Cutaneous Neoplasms and Normal Skin
- ClinicalTrials.gov ID
- NCT00588315
- Acronym / sponsor ID
- 99-099
- Conditions
- Skin Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,889 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Nov 1999 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Jan 2008 (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 investigate new non-invasive imaging techniques for the evaluation of skin lesions, as well as normal skin. Our primary goal is to collect and study these images of different skin lesions along with matching biopsy specimens. The long-term goal is to develop a technique that will improve the early detection of skin cancer and eliminate the need for many skin biopsies.
The High-resolution OCT (Apollo Medical Optics) device can provide both cross-sectional and en-face images with cellular information. Real-time color images through the same objective with OCT are also provided to show the OCT imaging location of lesion. The color image can be registered simultaneously on a larger dermoscopic image obtained by an external dermoscope. The imaging mode of cross-sectional, en-face and color image can be switched arbitrarily to align the lesion and obtain high-resolution images efficiently. The total imaging time is around 10 to 15 minutes depending on the number of images to be obtained.
To help identify more diagnostic features of optical imaging and better understand their histology correlation, we have developed a novel technique called "precision biopsy". Precision biopsy is an optical imaging guided, feature-targeted mini-biopsy. Once the feature of interest is identified and isolated by the optical imaging, a 2.0 mm punch biopsy is performed. Besides cosmetic benefit of minimal scarring, this tissue sparing biopsy captures the "feature of interest" for histology revelation.
Additionally, the histologic features of precision biopsy will be compared to images gathered by multi-modal optical imaging. The precision biopsy will also be compared to the traditional shave biopsy or shave excision, to determine whether the diagnostic information is comparable between the two methods.
For live remote control (LRC) imaging consultation, MSK dermatologist will based on his clinical examination. An imaging technician will perform the clinical and dermoscopic imaging, while the expert reader will perform confocal imaging remotely via a HIPPA compliant Webex platform.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| skin lesions | – | –The integrated dermoscopic-and-confocal microscopic video-mosaics will be used to compare morphologic patterns and cellular patterns to each other and to the corresponding pathology |
| normal skin | – | –The integrated dermoscopic-and-confocal microscopic video-mosaics will be used to compare morphologic patterns and cellular patterns to each other and to the corresponding pathology |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of the Dermatology, Clinical Immunology Services, Pediatrics and Radiology Oncology departments that are determined to have a skin lesion with anticipated epidermal and superficial dermal histologic alterations amenable to visualization by surface confocal microscopy will be offered the opportunity to participate in the study.
Key inclusion criteria (4 listed)
- Patients older than or equal to 10 years of age.
- Patients with a skin lesion with anticipated epidermal and superficial dermal histologic alterations amenable to visualization by surface confocal microscopy.
- Healthy volunteer subjects older than or equal to 10 years old.
- Ability to give informed consent.
Key exclusion criteria (1 listed)
- Patients who are allergic to fluorescein sodium.
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
The study is a descriptive one. No formal statistical testing of correlations will be performed.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Manu Jain, MD principal investigator
Memorial Sloan Kettering Cancer Center
4 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 Cancer, run by Memorial Sloan Kettering Cancer Center at 4 sites 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 4 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
The study is a descriptive one. No formal statistical testing of correlations will be performed. (time frame: 2 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 7 Jan 2026.