<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/NCT01700101</url>
  </required_header>
  <id_info>
    <org_study_id>20123</org_study_id>
    <nct_id>NCT01700101</nct_id>
  </id_info>
  <brief_title>MelaFind Evaluations for Patients With Multiple Nevi</brief_title>
  <official_title>MelaFind Evaluations for Patients With Multiple Nevi</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MELA Sciences, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MELA Sciences, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We have added objectives 4-6 to our updated study:&#xD;
&#xD;
      Study Objective 1: To determine whether the distribution of MelaFind scores is different for&#xD;
      different patients with multiple nevi, and whether such distributions can be utilized to&#xD;
      identify &quot;signature&quot; lesions for a given patient.&#xD;
&#xD;
      Study Objective 2: To investigate whether distributions of quantitative ABCD parameters&#xD;
      differ among patients and whether these qABCD parameters identify &quot;signature&quot; lesions.&#xD;
&#xD;
      Study Objective 3: To determine the feasibility of defining and using relative thresholds to&#xD;
      improve the specificity of MelaFind without sacrificing its high sensitivity.&#xD;
&#xD;
      Study Objective 4: To determine the repeatability of MelaFind scores for a given lesion for&#xD;
      different patient and lesion characteristics.&#xD;
&#xD;
      Study Objective 5: To identify patient and lesion characteristics that result in the highest&#xD;
      variability of MelaFind scores for a given lesion.&#xD;
&#xD;
      Study Objective 6: To use standard errors of MelaFind scores to propose a robust individual&#xD;
      threshold for lesions to be considered for biopsy to rule out melanoma on patients with&#xD;
      multiple nevi.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Multiple values and standard deviations of MelaFind scores for pigmented skin lesions</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <enrollment type="Actual">19</enrollment>
  <condition>Clinically Atypical Pigmented Skin Lesion</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have at least one lesion that meets the inclusion/exclusion criteria (see&#xD;
        eligibility criteria below) AND each lesion enrolled must be clinically atypical (i.e.,&#xD;
        contain at least one of the following ABCDEPRU characteristics: Asymmetry, Border&#xD;
        irregularity, Color variegation, Diameter &lt; 6 mm, Evolving, Patient's concern, Regression,&#xD;
        Ugly duckling).&#xD;
&#xD;
        Lesions should be selected to have characteristics that may affect the repeatability of&#xD;
        lesion scores: anatomic site (often exposed to UV - sun or tanning beds - or not;&#xD;
        sun-damage may affect the repeatability); lesion diameter (6 mm, e.g. ~5 mm or &gt; 6 mm,&#xD;
        e.g., 10 mm); and melanin content relative to normal skin (dark pigmentation or light&#xD;
        pigmentation).&#xD;
&#xD;
        A maximum of 8 lesions may be enrolled per patient&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Cutaneous lesions examined with MelaFind must satisfy all of the following inclusion&#xD;
        criteria:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  The lesion is pigmented (i.e., melanin, keratin, blood)&#xD;
&#xD;
          -  The diameter of the pigmented area is not &lt; 2 mm, and not &gt; 22 mm&#xD;
&#xD;
          -  The lesion is accessible to the MelaFind&#xD;
&#xD;
          -  The patient, or a legally authorized representative, has consented to participate in&#xD;
             the study and has signed the Informed Consent Form;&#xD;
&#xD;
        Cutaneous lesions that meet any of the following exclusion criteria will not be accepted:&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient has a known allergy to isopropyl alcohol&#xD;
&#xD;
          -  The lesion has been previously biopsied, excised, or traumatized&#xD;
&#xD;
          -  The skin is not intact (e.g., open sores, ulcers, bleeding)&#xD;
&#xD;
          -  The lesion is within 1 cm of the eye&#xD;
&#xD;
          -  The lesion is on mucosal surfaces (e.g., lips, genitals)&#xD;
&#xD;
          -  The lesion is on palmar hands&#xD;
&#xD;
          -  The lesion is on plantar feet&#xD;
&#xD;
          -  The lesion is on or under nails&#xD;
&#xD;
          -  The lesion is located on or in an area of visible scarring&#xD;
&#xD;
          -  The lesion contains foreign matter (e.g., tattoo, splinter, marker)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>August 25, 2014</last_update_submitted>
  <last_update_submitted_qc>August 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 26, 2014</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>Pigmentation Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT01700101
org study id: 20123
nct id: NCT01700101
lead sponsor: 
has dmc: No
We have added objectives 4-6 to our updated study:

      Study Objective 1: To determine whether the distribution of MelaFind scores is different for
      different patients with multiple nevi, and whether such distributions can be utilized to
      identify "signature" lesions for a given patient.

      Study Objective 2: To investigate whether distributions of quantitative ABCD parameters
      differ among patients and whether these qABCD parameters identify "signature" lesions.

      Study Objective 3: To determine the feasibility of defining and using relative thresholds to
      improve the specificity of MelaFind without sacrificing its high sensitivity.

      Study Objective 4: To determine the repeatability of MelaFind scores for a given lesion for
      different patient and lesion characteristics.

      Study Objective 5: To identify patient and lesion characteristics that result in the highest
      variability of MelaFind scores for a given lesion.

      Study Objective 6: To use standard errors of MelaFind scores to propose a robust individual
      threshold for lesions to be considered for biopsy to rule out melanoma on patients with
      multiple nevi.
observational model: Cohort
time perspective: Prospective
measure: Multiple values and standard deviations of MelaFind scores for pigmented skin lesions
time frame: 1 month
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Pigmentation Disorders