<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/NCT03290989</url>
  </required_header>
  <id_info>
    <org_study_id>PRURITCC</org_study_id>
    <nct_id>NCT03290989</nct_id>
  </id_info>
  <brief_title>Itch and Pain Characteristics in Skin Carcinomas</brief_title>
  <acronym>PRURITCC</acronym>
  <official_title>Itch and Pain Characteristics in Skin Carcinomas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to have better knowledge about sensations of patients with&#xD;
      skin carcinomas and to have data about characteristics of pain and pruritus . All patients&#xD;
      presenting with a suspicions lesion for skin carcinomas will be included and will respond to&#xD;
      a questionnaire. Demographics data, and histological data about skin carcinomas will be&#xD;
      collected.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2015</start_date>
  <completion_date type="Actual">July 31, 2015</completion_date>
  <primary_completion_date type="Actual">April 1, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate characteristics of pruritus in skin carcinomas</measure>
    <time_frame>Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma)</time_frame>
    <description>Questions about characteristics</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate characteristics of pruritus in skin carcinomas</measure>
    <time_frame>Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma</time_frame>
    <description>Numerical visual scale (EVA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate characteristics of pruritus in skin carcinomas</measure>
    <time_frame>Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma</time_frame>
    <description>5D-itch scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate characteristics of pain in skin carcinomas</measure>
    <time_frame>Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma</time_frame>
    <description>Numerical visual pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate characteristics of in skin carcinomas</measure>
    <time_frame>Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma</time_frame>
    <description>score DN4</description>
  </primary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Skin Carcinoma</condition>
  <condition>Skin Cancer</condition>
  <condition>Pruritus</condition>
  <eligibility>
    <study_pop>
      <textblock>
        From 1 April 2015 to 31 July 2015, all patients presenting with a skin lesion suspicious&#xD;
        for carcinoma (BCC or SCC) at the Department of Dermatology of the Military Hospital in&#xD;
        Brest were included in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        all patients with suspected skin carcinoma aged 18 years or more&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age under 18 years,&#xD;
&#xD;
          -  inability to complete the questionnaire because of cognitive impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHRU de Brest</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>September 18, 2017</last_update_submitted>
  <last_update_submitted_qc>September 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</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>Carcinoma</mesh_term>
    <mesh_term>Skin Neoplasms</mesh_term>
    <mesh_term>Pruritus</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/NCT03290989
org study id: PRURITCC
nct id: NCT03290989
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to have better knowledge about sensations of patients with
      skin carcinomas and to have data about characteristics of pain and pruritus . All patients
      presenting with a suspicions lesion for skin carcinomas will be included and will respond to
      a questionnaire. Demographics data, and histological data about skin carcinomas will be
      collected.
observational model: Case-Only
time perspective: Prospective
measure: Evaluate characteristics of pruritus in skin carcinomas
time frame: Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma)
description: Questions about characteristics
measure: Evaluate characteristics of pruritus in skin carcinomas
time frame: Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma
description: Numerical visual scale (EVA)
measure: Evaluate characteristics of pruritus in skin carcinomas
time frame: Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma
description: 5D-itch scale
measure: Evaluate characteristics of pain in skin carcinomas
time frame: Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma
description: Numerical visual pain
measure: Evaluate characteristics of in skin carcinomas
time frame: Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma
description: score DN4
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Skin Neoplasms
mesh term: Pruritus