xml: <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/NCT05976048</url>
    </required_header>
    <id_info>
      <org_study_id>2019-1313</org_study_id>
      <nct_id>NCT05976048</nct_id>
    </id_info>
    <brief_title>Implementation of Actinic Keratosis Guideline Among General Practitioners.</brief_title>
    <official_title>Implementation of Actinic Keratosis Guideline Among General Practitioners. Retrospective Cohort Study on Prescription Patterns in the Treatment of Actinic Keratosis.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Maastricht University Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Maastricht University Medical Center</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>
        This study investigates 5-fluorouracil cream prescription trends by general practitioners for&#xD;
        the treatment of field changes of actinic keratosis over the years 2016-2021. The aim is to&#xD;
        analyse whether the publication of the multidisciplinary guideline on suspect skin lesions&#xD;
        for general practitioners in 2017 has made an impact in the prescribing behaviour of general&#xD;
        practitioners.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Actinic keratosis is the most common epithelial precancerous lesion among the Caucasian race.&#xD;
        With an increase in prevalence worldwide due to an aging population and rise of ultraviolet&#xD;
        exposure actinic keratosis are among the most frequently encountered skin lesions in clinical&#xD;
        practice. Both dermatologists and general practitioners are increasingly confronted with&#xD;
        actinic keratosis, entailing to higher healthcare costs and time burden.&#xD;
  &#xD;
        There are many therapeutic modalities for the treatment of actinic keratosis, depending on&#xD;
        multiple factors such as distribution, characteristics, patient preference, side effects,&#xD;
        availability and costs. Treatment options can be divided into: lesion directed therapy en&#xD;
        field directed therapy. Both dermatologists and general practitioners can treat actinic&#xD;
        keratosis and 5-fluorouracil cream can also be prescribed by general practitioners.&#xD;
  &#xD;
        The objective of this study was to investigate 5-fluorouracil cream prescription trends by&#xD;
        general practitioner for the treatment of field changes of actinic keratosis over the years&#xD;
        2016-2021.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">March 1, 2020</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Actual">September 1, 2022</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage (%) of longitudinal changes in prescriptions of 5-fluorouracil cream</measure>
      <time_frame>Measurement years 2016, 2019 and 2021</time_frame>
      <description>Percentage (%) of longitudinal changes in prescriptions of 5-fluorouracil cream by general practitioners for the diagnosis actinic keratosis, measured from the Research Network Family Medicine Maastricht database between 2016 - 2021. The Research Network Family Medicine is a registration database with information about the affiliated general practices.</description>
    </primary_outcome>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Actinic Keratoses</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Data of patients with actinic keratosis in the general practitioners extracted from the&#xD;
          Research network family medicine (RNFM) Maastricht database between 2016 - 2021.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age &gt;18 years&#xD;
  &#xD;
            -  diagnosis actinic keratosis (clinical diagnosed or by biopsy)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  cutaneous malignancy (suspicion)&#xD;
  &#xD;
            -  immunosuppressive co-medication.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Klara Mosterd, prof.dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Maastricht UMC+</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Ellen Oyen</name>
        <address>
          <city>Maastricht</city>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>actinic keratosis</keyword>
    <keyword>general physician</keyword>
    <keyword>5-fluorouracil cream</keyword>
    <keyword>general practitioner</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Keratosis, Actinic</mesh_term>
      <mesh_term>Keratosis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05976048
  org study id: 2019-1313
  nct id: NCT05976048
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study investigates 5-fluorouracil cream prescription trends by general practitioners for
        the treatment of field changes of actinic keratosis over the years 2016-2021. The aim is to
        analyse whether the publication of the multidisciplinary guideline on suspect skin lesions
        for general practitioners in 2017 has made an impact in the prescribing behaviour of general
        practitioners.
  Actinic keratosis is the most common epithelial precancerous lesion among the Caucasian race.
        With an increase in prevalence worldwide due to an aging population and rise of ultraviolet
        exposure actinic keratosis are among the most frequently encountered skin lesions in clinical
        practice. Both dermatologists and general practitioners are increasingly confronted with
        actinic keratosis, entailing to higher healthcare costs and time burden.
  
        There are many therapeutic modalities for the treatment of actinic keratosis, depending on
        multiple factors such as distribution, characteristics, patient preference, side effects,
        availability and costs. Treatment options can be divided into: lesion directed therapy en
        field directed therapy. Both dermatologists and general practitioners can treat actinic
        keratosis and 5-fluorouracil cream can also be prescribed by general practitioners.
  
        The objective of this study was to investigate 5-fluorouracil cream prescription trends by
        general practitioner for the treatment of field changes of actinic keratosis over the years
        2016-2021.
  observational model: Cohort
  time perspective: Retrospective
  measure: Percentage (%) of longitudinal changes in prescriptions of 5-fluorouracil cream
  time frame: Measurement years 2016, 2019 and 2021
  description: Percentage (%) of longitudinal changes in prescriptions of 5-fluorouracil cream by general practitioners for the diagnosis actinic keratosis, measured from the Research Network Family Medicine Maastricht database between 2016 - 2021. The Research Network Family Medicine is a registration database with information about the affiliated general practices.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Klara Mosterd, prof.dr.
  role: Principal Investigator
  affiliation: Maastricht UMC+
  facility: 
  country: Netherlands
  responsible party type: Sponsor
  mesh term: Keratosis, Actinic
  mesh term: Keratosis