Skin CancerNCT04411810
SpotCheck: Comparison of Enhanced Telemedicine Versus In-person Evaluation for the Diagnosis of Skin Cancer
A study testing Nevisense 3.0, Dermlite Cam and Skin biopsy in people with Skin Cancer, run by NYU Langone Health at 1 site in United States.
Trial summary
The overall goal of this research is to develop a platform that can increase patient access to expert skin cancer diagnostic services via telemedicine. This is especially important for medically underserved areas where melanoma outcomes are worse than in areas with greater access to in-person evaluations. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer
- What is being tested?
- Nevisense 3.0, Dermlite Cam and Skin biopsy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2020to 4 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be 18 years of age or older
- Have 1-3 lesions for evaluation
Who cannot join
- Lesions of the hair-bearing scalp, in the mouth, on the lips, genitalia, nails, on/around the eyes, inside the ear
Trial locations and contacts
1 site in 1 country.
About this study
The overall goal of this research is to develop a platform that can increase patient access to expert skin cancer diagnostic services via telemedicine. This is especially important for medically underserved areas where melanoma outcomes are worse than in areas with greater access to in-person evaluations. If successful, the widespread availability of such services would be combined with public education efforts to encourage individuals with changing skin lesions to seek evaluation. With decreased travel times to high quality diagnostic services, such efforts may decrease the diagnosis of more advanced melanomas (with a concomitant increase in the diagnosis of earlier stage tumors), and potentially decrease melanoma mortality.
Read the detailed description
This is a prospective pilot study of a store-and-forward telemedicine diagnostic assessment of participant-selected skin lesions concerning for skin cancer, controlled against an in-person dermatologist assessment (gold standard evaluation). The study will be a single arm design with each participant undergoing telemedicine data acquisition (i.e. clinical and dermoscopic imaging and Nevisense measurement), immediately followed by the in-person dermatologist assessment. The in-person dermatologist will be blinded to the Nevisense score at the time of the visit. Using the telemedicine data, the teledermatology team will render a biopsy/no-biopsy recommendation within 3 business days of the participant evaluation. They will be blinded to the results of the in-person dermatologist's diagnostic evaluation.
- Conditions
- Skin Cancer
- Being tested
- Nevisense 3.0, Dermlite Cam, Skin biopsy, Barco Demetra
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nevisense 3.0Device
Nevisense, an AI-based point-of-care system for the non-invasive evaluation of irregular moles remains the only FDA approved system available for melanoma detection in the US. Nevisense 3.0 will be used as a one-time exposure of <8 seconds per lesion. Disposable electrodes that contact the participant are 5mm x 5mm in size. Nevisense 3.0 measures electrical impedance of skin lesions and provides an output called the electrical impedence spectroscopy (EIS) score. Electrical impedance is a measure of a material's overall resistance to the flow of alternating electric currents of various frequencies. The principle is that electrical impedance is different in normal versus abnormal tissue.
Dermlite CamDevice
Dermlite Cam is a digital camera that captures images of the skin under cross-polarized and non-polarized light and is 510(k) exempt. The DermLite Cam device appears as a single piece camera with a charging cable and USB computer cable. As part of the camera unit, an extensor arm exists to allow for the capture of standardized clinical images. The DermLite Cam will be used to acquire 3 images of <5 seconds per lesion (one clinical, one polarized dermoscopic, and one non-polarized dermoscopic). NOTE - for the purposes of this study, teledermatology images (dermoscopic and clinical - at approximately 6 inches, 12 inches, and 18 inches) were taken using the Barco Demetra after technical issues arose that prohibited the continued use of the Dermlite Cam.
Skin biopsyProcedure or surgery
A skin biopsy is a small procedure that removes a sample of skin from the surface of the body. The method utilized will be either a shave or punch technique. The maximum size of a punch biopsy will be 6mm and these wounds are generally closed with no more than 2-3 sutures. A skin biopsy takes <15 minutes including preparation time, administration of intradermal anesthesia using lidocaine 1% with epinephrine 1:100,000, removal of the skin sample, achievement of hemostasis, dressing the wound, and providing instructions for home care. Samples will be placed formalin for routine processing.
Barco DemetraDevice
Barco Demetra is a non-invasive skin imaging system, which acquires multispectral and white light dermoscopic images and clinical photographs of the skin which can then be stored, retrieved, displayed, and reviewed by medical practitioners. The Barco Demetra received 510(k) Premarket approval (K192829). The system involves a hardware imaging device and a stand-alone software application. The hardware device is a portable, battery-powered medical device for acquiring and visualizing images of the skin and uploads all images to cloud storage. The software application is cloud software with an associated web application; it can be used to visualize images and related data and can generate consultation reports. For the purposes of this study, teledermatology images (dermoscopic and clinical - at approximately 6 inches, 12 inches, and 18 inches) were taken using the Barco Demetra after technical issues arose that prohibited the continued use of the Dermlite Cam.
| Study group | Role | What they receive |
|---|---|---|
| Participants with skin lesions | Experimental | Participants who have up to 3 concerning skin lesions will be evaluated by both an in-person dermatologist and a team of three teledermatologists(board-certified dermatologists). The teledermatoogy team will deliver a consensus recommendation. If either the in-person dermatologist or teledermatologists are concerned that the skin spot(s) may be a skin cancer, a biopsy will be recommended and can be performed at no charge. Or if both agree that the spot(s) are not concerning for skin cancer, no biopsy will be needed. Receives: Device: Nevisense 3.0; Device: Dermlite Cam; Procedure: Skin biopsy; Device: Barco Demetra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Skin Cancer Diagnosis: In-Person Assessment
To compare the accuracy of skin cancer diagnoses between in-person recommendation and the telemedicine (tele) recommendation, the number of "positive" evaluations (i.e. recommended for biopsy) that were truly skin cancer plus the number of "negative" evaluations (i.e. not recommended for biopsy) that were truly non-cancerous divided by the total number of skin lesions evaluated is calculated.
Measured: End of the study (4 weeks)
Accuracy of Skin Cancer Diagnosis: Telemedicine Without Nevisense
To compare the accuracy of skin cancer diagnoses between in-person recommendation and the telemedicine (tele) recommendation, the number of "positive" evaluations (i.e. recommended for biopsy) that were truly skin cancer plus the number of "negative" evaluations (i.e. not recommended for biopsy) that were truly non-cancerous divided by the total number of skin lesions evaluated is calculated.
Measured: End of the study (4 weeks)
Accuracy of Skin Cancer Diagnosis: Telemedicine With Nevisense
To compare the accuracy of skin cancer diagnoses between in-person recommendation and the telemedicine (tele) recommendation, the number of "positive" evaluations (i.e. recommended for biopsy) that were truly skin cancer plus the number of "negative" evaluations (i.e. not recommended for biopsy) that were truly non-cancerous divided by the total number of skin lesions evaluated is calculated.
Measured: End of the study (4 weeks)
Secondary outcomes (18)
Sensitivity of Telemedicine Evaluation in Diagnosing Skin Cancer: Without Nevisense
Assessment of the dermatologist's ability to designate an individual who has skin cancer as "positive" using the telemedicine platform without nevisense.
Measured: End of the study (4 weeks)
Sensitivity of Telemedicine Evaluation in Diagnosing Skin Cancer: With Nevisense
Assessment of the dermatologist's ability to designate an individual who has skin cancer as "positive" using the telemedicine platform with nevisense.
Measured: End of the study (4 weeks)
Sensitivity of In-Person Evaluation in Diagnosing Skin Cancer
Assessment of the dermatologist's ability to designate an individual who has skin cancer as "positive" during in-person evaluations.
Measured: End of the study (4 weeks)
Specificity of Telemedicine Evaluation in Diagnosing Skin Cancer: Without Nevisense
Assessment of the dermatologist's ability to designate an individual who does not have skin cancer as "negative" using the telemedicine platform without nevisense.
Measured: End of the study (4 weeks)
Specificity of Telemedicine Evaluation in Diagnosing Skin Cancer: With Nevisense
Assessment of the dermatologist's ability to designate an individual who does not have skin cancer as "negative" using the telemedicine platform with Nevisense.
Measured: End of the study (4 weeks)
Specificity of In-Person Evaluation in Diagnosing Skin Cancer
Assessment of the dermatologist's ability to designate an individual who does not have skin cancer as "negative" during in-person evaluations.
Measured: End of the study (4 weeks)
False-Positive Rate of Telemedicine Evaluation: Without Nevisense
The number of false-positives (i.e., diagnosing a patient with skin cancer when no skin cancer is present) out of the total number of telemedicine evaluations without Nevisense.
Measured: End of the study (4 weeks)
False-Positive Rate of Telemedicine Evaluation: With Nevisense
The number of false-positives (i.e., diagnosing a patient with skin cancer when no skin cancer is present) out of the total number of telemedicine evaluations with Nevisense.
Measured: End of the study (4 weeks)
False-Positive Rate of In-Person Evaluation
The number of false-positives (i.e., diagnosing a patient with skin cancer when no skin cancer is present) out of the total number of in-person evaluations.
Measured: End of the study (4 weeks)
False-Negative Rate of Telemedicine Evaluation: Without Nevisense
The number of false-negatives (i.e., indicating a patient does not have skin cancer when skin cancer is present) out of the total number of telemedicine evaluations without Nevisense.
Measured: End of the study (4 weeks)
False-Negative Rate of Telemedicine Evaluation: With Nevisense
The number of false-negatives (i.e., indicating a patient does not have skin cancer when skin cancer is present) out of the total number of telemedicine evaluations with Nevisense.
Measured: End of the study (4 weeks)
False-Negative Rate of In-Person Evaluation
The number of false-negatives (i.e., indicating a patient does not have skin cancer when skin cancer is present) out of the total number of in-person evaluations.
Measured: End of the study (4 weeks)
Positive Predictive Value of Telemedicine Evaluation: Without Nevisense
The probability that a patient with a positive (abnormal) test result via telemedicine evaluation without Nevisense actually has skin cancer.
Measured: End of the study (4 weeks)
Positive Predictive Value of Telemedicine Evaluation: With Nevisense
The probability that a patient with a positive (abnormal) test result via telemedicine evaluation with Nevisense actually has skin cancer.
Measured: End of the study (4 weeks)
Positive Predictive Value of In-Person Evaluation
The probability that a patient with a positive (abnormal) test result via in-person evaluation actually has skin cancer.
Measured: End of the study (4 weeks)
Negative Predictive Value of Telemedicine Evaluation: Without Nevisense
The probability that a person with a negative (normal) test result via telemedicine evaluation without Nevisense is truly free of disease.
Measured: End of the study (4 weeks)
Negative Predictive Value of Telemedicine Evaluation: With Nevisense
The probability that a person with a negative (normal) test result via telemedicine evaluation with Nevisense is truly free of disease.
Measured: End of the study (4 weeks)
Negative Predictive Value of In-Person Evaluation
The probability that a person with a negative (normal) test result via in-person evaluation is truly free of disease.
Measured: End of the study (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start20 Aug 2020
- Primary completion3 Mar 2023
- Study completion4 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Polsky, MD, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411810
- Sponsor's protocol ID
- 19-01242
- Status last verified
- Apr 2024
- First submitted
- 28 May 2020
- Last updated
- 8 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SpotCheck: Comparison of Enhanced Telemedicine Versus In-person Evaluation for the Diagnosis of Skin Cancer
- ClinicalTrials.gov ID
- NCT04411810
- Acronym / sponsor ID
- 19-01242
- Conditions
- Skin Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 4 Mar 2023 (actual)
- First posted
- 2 Jun 2020 (actual)
- Results
- Posted 8 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this research is to develop a platform that can increase patient access to expert skin cancer diagnostic services via telemedicine. This is especially important for medically underserved areas where melanoma outcomes are worse than in areas with greater access to in-person evaluations. If successful, the widespread availability of such services would be combined with public education efforts to encourage individuals with changing skin lesions to seek evaluation. With decreased travel times to high quality diagnostic services, such efforts may decrease the diagnosis of more advanced melanomas (with a concomitant increase in the diagnosis of earlier stage tumors), and potentially decrease melanoma mortality.
Detailed description
This is a prospective pilot study of a store-and-forward telemedicine diagnostic assessment of participant-selected skin lesions concerning for skin cancer, controlled against an in-person dermatologist assessment (gold standard evaluation). The study will be a single arm design with each participant undergoing telemedicine data acquisition (i.e. clinical and dermoscopic imaging and Nevisense measurement), immediately followed by the in-person dermatologist assessment. The in-person dermatologist will be blinded to the Nevisense score at the time of the visit. Using the telemedicine data, the teledermatology team will render a biopsy/no-biopsy recommendation within 3 business days of the participant evaluation. They will be blinded to the results of the in-person dermatologist's diagnostic evaluation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with skin lesions | Experimental | Device: Nevisense 3.0, Device: Dermlite Cam, Procedure: Skin biopsy, Device: Barco DemetraParticipants who have up to 3 concerning skin lesions will be evaluated by both an in-person dermatologist and a team of three teledermatologists(board-certified dermatologists). The teledermatoogy team will deliver a consensus recommendation. If either the in-person dermatologist or teledermatologists are concerned that the skin spot(s) may be a skin cancer, a biopsy will be recommended and can be performed at no charge. Or if both agree that the spot(s) are not concerning for skin cancer, no biopsy will be needed. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Be 18 years of age or older
- Have 1-3 lesions for evaluation
Key exclusion criteria (1 listed)
- Lesions of the hair-bearing scalp, in the mouth, on the lips, genitalia, nails, on/around the eyes, inside the ear
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 |
|---|---|---|
| Nevisense 3.0Nevisense, an AI-based point-of-care system for the non-invasive evaluation of irregular moles remains the only FDA approved system available for melanoma detection in the US. Nevisense 3.0 will be used as a one-time exposure of <8 seconds per lesion. Disposable electrodes that contact the participant are 5mm x 5mm in size. Nevisense 3.0 measures electrical impedance of skin lesions and provides an output called the electrical impedence spectroscopy (EIS) score. Electrical impedance is a measure of a material's overall resistance to the flow of alternating electric currents of various frequencies. The principle is that electrical impedance is different in normal versus abnormal tissue. | Device | Participants with skin lesions |
| Dermlite CamDermlite Cam is a digital camera that captures images of the skin under cross-polarized and non-polarized light and is 510(k) exempt. The DermLite Cam device appears as a single piece camera with a charging cable and USB computer cable. As part of the camera unit, an extensor arm exists to allow for the capture of standardized clinical images. The DermLite Cam will be used to acquire 3 images of <5 seconds per lesion (one clinical, one polarized dermoscopic, and one non-polarized dermoscopic). NOTE - for the purposes of this study, teledermatology images (dermoscopic and clinical - at approximately 6 inches, 12 inches, and 18 inches) were taken using the Barco Demetra after technical issues arose that prohibited the continued use of the Dermlite Cam. | Device | Participants with skin lesions |
| Skin biopsyA skin biopsy is a small procedure that removes a sample of skin from the surface of the body. The method utilized will be either a shave or punch technique. The maximum size of a punch biopsy will be 6mm and these wounds are generally closed with no more than 2-3 sutures. A skin biopsy takes <15 minutes including preparation time, administration of intradermal anesthesia using lidocaine 1% with epinephrine 1:100,000, removal of the skin sample, achievement of hemostasis, dressing the wound, and providing instructions for home care. Samples will be placed formalin for routine processing. | Procedure or surgery | Participants with skin lesions |
| Barco DemetraBarco Demetra is a non-invasive skin imaging system, which acquires multispectral and white light dermoscopic images and clinical photographs of the skin which can then be stored, retrieved, displayed, and reviewed by medical practitioners. The Barco Demetra received 510(k) Premarket approval (K192829). The system involves a hardware imaging device and a stand-alone software application. The hardware device is a portable, battery-powered medical device for acquiring and visualizing images of the skin and uploads all images to cloud storage. The software application is cloud software with an associated web application; it can be used to visualize images and related data and can generate consultation reports. For the purposes of this study, teledermatology images (dermoscopic and clinical - at approximately 6 inches, 12 inches, and 18 inches) were taken using the Barco Demetra after technical issues arose that prohibited the continued use of the Dermlite Cam. | Device | Participants with skin lesions |
Primary outcome
Accuracy of Skin Cancer Diagnosis: In-Person Assessment
Time frame: End of the study (4 weeks)
To compare the accuracy of skin cancer diagnoses between in-person recommendation and the telemedicine (tele) recommendation, the number of "positive" evaluations (i.e. recommended for biopsy) that were truly skin cancer plus the number of "negative" evaluations (i.e. not recommended for biopsy) that were truly non-cancerous divided by the total number of skin lesions evaluated is calculated.
Accuracy of Skin Cancer Diagnosis: Telemedicine Without Nevisense
Time frame: End of the study (4 weeks)
To compare the accuracy of skin cancer diagnoses between in-person recommendation and the telemedicine (tele) recommendation, the number of "positive" evaluations (i.e. recommended for biopsy) that were truly skin cancer plus the number of "negative" evaluations (i.e. not recommended for biopsy) that were truly non-cancerous divided by the total number of skin lesions evaluated is calculated.
Accuracy of Skin Cancer Diagnosis: Telemedicine With Nevisense
Time frame: End of the study (4 weeks)
To compare the accuracy of skin cancer diagnoses between in-person recommendation and the telemedicine (tele) recommendation, the number of "positive" evaluations (i.e. recommended for biopsy) that were truly skin cancer plus the number of "negative" evaluations (i.e. not recommended for biopsy) that were truly non-cancerous divided by the total number of skin lesions evaluated is calculated.
18 secondary outcomes
Sensitivity of Telemedicine Evaluation in Diagnosing Skin Cancer: Without Nevisense
Time frame: End of the study (4 weeks)
Sensitivity of Telemedicine Evaluation in Diagnosing Skin Cancer: With Nevisense
Time frame: End of the study (4 weeks)
Sensitivity of In-Person Evaluation in Diagnosing Skin Cancer
Time frame: End of the study (4 weeks)
Specificity of Telemedicine Evaluation in Diagnosing Skin Cancer: Without Nevisense
Time frame: End of the study (4 weeks)
Specificity of Telemedicine Evaluation in Diagnosing Skin Cancer: With Nevisense
Time frame: End of the study (4 weeks)
Specificity of In-Person Evaluation in Diagnosing Skin Cancer
Time frame: End of the study (4 weeks)
False-Positive Rate of Telemedicine Evaluation: Without Nevisense
Time frame: End of the study (4 weeks)
False-Positive Rate of Telemedicine Evaluation: With Nevisense
Time frame: End of the study (4 weeks)
False-Positive Rate of In-Person Evaluation
Time frame: End of the study (4 weeks)
False-Negative Rate of Telemedicine Evaluation: Without Nevisense
Time frame: End of the study (4 weeks)
False-Negative Rate of Telemedicine Evaluation: With Nevisense
Time frame: End of the study (4 weeks)
False-Negative Rate of In-Person Evaluation
Time frame: End of the study (4 weeks)
Positive Predictive Value of Telemedicine Evaluation: Without Nevisense
Time frame: End of the study (4 weeks)
Positive Predictive Value of Telemedicine Evaluation: With Nevisense
Time frame: End of the study (4 weeks)
Positive Predictive Value of In-Person Evaluation
Time frame: End of the study (4 weeks)
Negative Predictive Value of Telemedicine Evaluation: Without Nevisense
Time frame: End of the study (4 weeks)
Negative Predictive Value of Telemedicine Evaluation: With Nevisense
Time frame: End of the study (4 weeks)
Negative Predictive Value of In-Person Evaluation
Time frame: End of the study (4 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
David Polsky, MD, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nevisense 3.0, Dermlite Cam and Skin biopsy in people with Skin Cancer, run by NYU Langone Health 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 2 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: finished, as of the sponsor's last update on 8 Apr 2024. 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?
Yes. Results are posted in the registry (first posted 8 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Accuracy of Skin Cancer Diagnosis: In-Person Assessment (time frame: End of the study (4 weeks)). The study lists 3 primary outcomes in all. 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 8 Apr 2024.