<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04411810</url>
  </required_header>
  <id_info>
    <org_study_id>19-01242</org_study_id>
    <nct_id>NCT04411810</nct_id>
  </id_info>
  <brief_title>SpotCheck: Comparison of Enhanced Telemedicine Versus In-person Evaluation for the Diagnosis of Skin Cancer</brief_title>
  <official_title>SpotCheck: Comparison of Enhanced Telemedicine Versus In-person Evaluation for the Diagnosis of Skin Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall goal of this research is to develop a platform that can increase patient access&#xD;
      to expert skin cancer diagnostic services via telemedicine. This is especially important for&#xD;
      medically underserved areas where melanoma outcomes are worse than in areas with greater&#xD;
      access to in-person evaluations. If successful, the widespread availability of such services&#xD;
      would be combined with public education efforts to encourage individuals with changing skin&#xD;
      lesions to seek evaluation. With decreased travel times to high quality diagnostic services,&#xD;
      such efforts may decrease the diagnosis of more advanced melanomas (with a concomitant&#xD;
      increase in the diagnosis of earlier stage tumors), and potentially decrease melanoma&#xD;
      mortality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective pilot study of a store-and-forward telemedicine diagnostic assessment&#xD;
      of participant-selected skin lesions concerning for skin cancer, controlled against an&#xD;
      in-person dermatologist assessment (gold standard evaluation). The study will be a single arm&#xD;
      design with each participant undergoing telemedicine data acquisition (i.e. clinical and&#xD;
      dermoscopic imaging and Nevisense measurement), immediately followed by the in-person&#xD;
      dermatologist assessment. The in-person dermatologist will be blinded to the Nevisense score&#xD;
      at the time of the visit. Using the telemedicine data, the teledermatology team will render a&#xD;
      biopsy/no-biopsy recommendation within 3 business days of the participant evaluation. They&#xD;
      will be blinded to the results of the in-person dermatologist's diagnostic evaluation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 20, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Actual">March 3, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Agreement Between Telemedicine and In-Person Treatment Recommendation</measure>
    <time_frame>End of the study (4 weeks)</time_frame>
    <description>To determine the agreement between in-person recommendation and the telemedicine (tele) recommendation, the number of discordant benign vs. malignant diagnoses will be calculated; specifically, the number of subjects that were recommended a biopsy from the in-person dermatologist but were recommended no biopsy from the teledermatology team, and the number of subjects that were recommended no biopsy from the in-person dermatologist but biopsy by the teledermatologist team.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of Telemedicine Evaluation in Diagnosing Skin Cancer</measure>
    <time_frame>End of the study (4 weeks)</time_frame>
    <description>Assessment of the dermatologist's ability to designate an individual who has skin cancer as &quot;positive&quot; using the telemedicine platform.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of In-Person Evaluation in Diagnosing Skin Cancer</measure>
    <time_frame>End of the study (4 weeks)</time_frame>
    <description>Assessment of the dermatologist's ability to designate an individual who has skin cancer as &quot;positive&quot; during in-person evaluations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of Telemedicine Evaluation in Diagnosing Skin Cancer</measure>
    <time_frame>End of the study (4 weeks)</time_frame>
    <description>Assessment of the dermatologist's ability to designate an individual who does not have skin cancer as &quot;negative&quot; using the telemedicine platform.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of In-Person Evaluation in Diagnosing Skin Cancer</measure>
    <time_frame>End of the study (4 weeks)</time_frame>
    <description>Assessment of the dermatologist's ability to designate an individual who does not have skin cancer as &quot;negative&quot; during in-person evaluations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>False-Positive Rate of Telemedicine Evaluation</measure>
    <time_frame>End of the study (4 weeks)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>False-Positive Rate of In-Person Evaluation</measure>
    <time_frame>End of the study (4 weeks)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>False-Negative Rate of Telemedicine Evaluation</measure>
    <time_frame>End of the study (4 weeks)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>False-Negative Rate of In-Person Evaluation</measure>
    <time_frame>End of the study (4 weeks)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive Predictive Value of Telemedicine Evaluation</measure>
    <time_frame>End of the study (4 weeks)</time_frame>
    <description>The probability that a patient with a positive (abnormal) test result via telemedicine evaluation actually has skin cancer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive Predictive Value of In-Person Evaluation</measure>
    <time_frame>End of the study (4 weeks)</time_frame>
    <description>The probability that a patient with a positive (abnormal) test result via in-person evaluation actually has skin cancer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Negative Predictive Value of Telemedicine Evaluation</measure>
    <time_frame>End of the study (4 weeks)</time_frame>
    <description>The probability that a person with a negative (normal) test result via telemedicine evaluation is truly free of disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Negative Predictive Value of In-Person Evaluation</measure>
    <time_frame>End of the study (4 weeks)</time_frame>
    <description>The probability that a person with a negative (normal) test result via in-person evaluation is truly free of disease.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">149</enrollment>
  <condition>Skin Cancer</condition>
  <arm_group>
    <arm_group_label>Participants with skin lesions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nevisense 3.0</intervention_name>
    <description>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 &lt;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.</description>
    <arm_group_label>Participants with skin lesions</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dermlite Cam</intervention_name>
    <description>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 &lt;5 seconds per lesion (one clinical, one polarized dermoscopic, and one non-polarized dermoscopic).</description>
    <arm_group_label>Participants with skin lesions</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Skin biopsy</intervention_name>
    <description>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 &lt;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.</description>
    <arm_group_label>Participants with skin lesions</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be 18 years of age or older&#xD;
&#xD;
          -  Have 1-3 lesions for evaluation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lesions of the hair-bearing scalp, in the mouth, on the lips, genitalia, nails,&#xD;
             on/around the eyes, inside the ear&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Polsky, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NYU Langone Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>August 28, 2023</last_update_submitted>
  <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Skin Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.</ipd_time_frame>
    <ipd_access_criteria>The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to David.Polsky@nyulangone.org To gain access, data requestors will need to sign a data access agreement.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04411810
org study id: 19-01242
nct id: NCT04411810
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Percentage of Agreement Between Telemedicine and In-Person Treatment Recommendation
time frame: End of the study (4 weeks)
description: To determine the agreement between in-person recommendation and the telemedicine (tele) recommendation, the number of discordant benign vs. malignant diagnoses will be calculated; specifically, the number of subjects that were recommended a biopsy from the in-person dermatologist but were recommended no biopsy from the teledermatology team, and the number of subjects that were recommended no biopsy from the in-person dermatologist but biopsy by the teledermatologist team.
measure: Sensitivity of Telemedicine Evaluation in Diagnosing Skin Cancer
time frame: End of the study (4 weeks)
description: Assessment of the dermatologist's ability to designate an individual who has skin cancer as "positive" using the telemedicine platform.
measure: Sensitivity of In-Person Evaluation in Diagnosing Skin Cancer
time frame: End of the study (4 weeks)
description: Assessment of the dermatologist's ability to designate an individual who has skin cancer as "positive" during in-person evaluations.
measure: Specificity of Telemedicine Evaluation in Diagnosing Skin Cancer
time frame: End of the study (4 weeks)
description: Assessment of the dermatologist's ability to designate an individual who does not have skin cancer as "negative" using the telemedicine platform.
measure: Specificity of In-Person Evaluation in Diagnosing Skin Cancer
time frame: End of the study (4 weeks)
description: Assessment of the dermatologist's ability to designate an individual who does not have skin cancer as "negative" during in-person evaluations.
measure: False-Positive Rate of Telemedicine Evaluation
time frame: End of the study (4 weeks)
description: 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.
measure: False-Positive Rate of In-Person Evaluation
time frame: End of the study (4 weeks)
description: 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.
measure: False-Negative Rate of Telemedicine Evaluation
time frame: End of the study (4 weeks)
description: 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.
measure: False-Negative Rate of In-Person Evaluation
time frame: End of the study (4 weeks)
description: 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.
measure: Positive Predictive Value of Telemedicine Evaluation
time frame: End of the study (4 weeks)
description: The probability that a patient with a positive (abnormal) test result via telemedicine evaluation actually has skin cancer.
measure: Positive Predictive Value of In-Person Evaluation
time frame: End of the study (4 weeks)
description: The probability that a patient with a positive (abnormal) test result via in-person evaluation actually has skin cancer.
measure: Negative Predictive Value of Telemedicine Evaluation
time frame: End of the study (4 weeks)
description: The probability that a person with a negative (normal) test result via telemedicine evaluation is truly free of disease.
measure: Negative Predictive Value of In-Person Evaluation
time frame: End of the study (4 weeks)
description: The probability that a person with a negative (normal) test result via in-person evaluation is truly free of disease.
arm group label: Participants with skin lesions
arm group type: Experimental
description: 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.
intervention type: Device
intervention name: Nevisense 3.0
description: 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.
arm group label: Participants with skin lesions
intervention type: Device
intervention name: Dermlite Cam
description: 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).
arm group label: Participants with skin lesions
intervention type: Procedure
intervention name: Skin biopsy
description: 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.
arm group label: Participants with skin lesions
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David Polsky, MD, PhD
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Skin Neoplasms
sharing ipd: Yes
ipd description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
ipd access criteria: The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to David.Polsky@nyulangone.org To gain access, data requestors will need to sign a data access agreement.