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/NCT05987579</url>
    </required_header>
    <id_info>
      <org_study_id>2021-2706</org_study_id>
      <nct_id>NCT05987579</nct_id>
    </id_info>
    <brief_title>Surgical Treatment of Stage T3 Squamous Cell Carcinomas of the Scalp</brief_title>
    <official_title>Surgical Treatment of Stage T3 Squamous Cell Carcinomas of the Scalp</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 examines tumor- en surgical characteristics of stage T3 cutaneous squamous cell&#xD;
        carcinomas on the scalp, diagnosed between 2010 and 2018. Histological data and patient- and&#xD;
        tumor characteristics were collected.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cutaneous squamous cell carcinoma is the second most common type of non-melanoma skin cancer,&#xD;
        following basal cell carcinoma. Following the American Joint Committee on Cancer Tumour, Node&#xD;
        and Metastasis (TNM) Classification of Malignant Tumors staging system (TNM8), T3 cutaneous&#xD;
        squamous cell carcinomas comprise an interesting group, especially on the scalp, because of&#xD;
        the thin subcutaneous fat layer. According to the TNM8 criteria, T3 include all cutaneous&#xD;
        squamous cel carcinomas with greatest tumor dimension ≥4cm, tumors with minimal bone erosion&#xD;
        or perineural growth (defined as involvement of the nerve sheath of a nerve lying deeper than&#xD;
        the dermis or measuring 0.1mm or larger in caliber or showing clinical or radiographic&#xD;
        involvement of nerves without invasion of the skull base) or with deep invasion. Deep&#xD;
        invasion is defined as invasion deeper than the subcutaneous fat or a tumor thickness &gt;6mm.&#xD;
        The scalp has a natural anatomical and oncological barrier for extension in depth known as&#xD;
        the epicranial aponeurosis, also called the galea aponeurotica.&#xD;
  &#xD;
        This retrospective study, examines the tumor- en surgical characteristics of these stage T3&#xD;
        cutaneous squamous cell carcinomas on the scalp.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">May 3, 2021</start_date>
    <completion_date type="Anticipated">July 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2023</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>Surgical characteristics</measure>
      <time_frame>Between 2010-2017</time_frame>
      <description>Choice of treatment, complications, reconstruction types</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tumor characteristics</measure>
      <time_frame>Between 2010-2017</time_frame>
      <description>Histological data on invasion depth, tumor differentiation</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patients characteristics</measure>
      <time_frame>Between 2010-2017</time_frame>
      <description>Risk factors, comorbidities</description>
    </primary_outcome>
    <enrollment type="Actual">104</enrollment>
    <condition>Squamous Cell Carcinoma</condition>
    <condition>Surgery</condition>
    <condition>Cancer Head Neck</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Data from patients are collected retrospectively using data from the Pathological&#xD;
          Anatomical National Automated Archive (PALGA) of the MUMC+ between 2010 - 2018. The TNM&#xD;
          staging of all cutaneous squamous cell carcinomas in the research period was reassessed and&#xD;
          classified following the TNM 8 criteria.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  stage T3 cutaneous squamous cell carcinoma of the scalp (histologically proven)&#xD;
  &#xD;
            -  surgical treatment or radiotherapy treatment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  metastasis by diagnosis&#xD;
  &#xD;
            -  stage T1/T2/T4&#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>Nicole Kelleners-Smeets, 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>
    <reference>
      <citation>Amin MB, Greene FL, Edge SB, Compton CC, Gershenwald JE, Brookland RK, Meyer L, Gress DM, Byrd DR, Winchester DP. The Eighth Edition AJCC Cancer Staging Manual: Continuing to build a bridge from a population-based to a more &quot;personalized&quot; approach to cancer staging. CA Cancer J Clin. 2017 Mar;67(2):93-99. doi: 10.3322/caac.21388. Epub 2017 Jan 17.</citation>
      <PMID>28094848</PMID>
    </reference>
    <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 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 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>Carcinoma</mesh_term>
      <mesh_term>Carcinoma, Squamous Cell</mesh_term>
      <mesh_term>Head and Neck Neoplasms</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/NCT05987579
  org study id: 2021-2706
  nct id: NCT05987579
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study examines tumor- en surgical characteristics of stage T3 cutaneous squamous cell
        carcinomas on the scalp, diagnosed between 2010 and 2018. Histological data and patient- and
        tumor characteristics were collected.
  Cutaneous squamous cell carcinoma is the second most common type of non-melanoma skin cancer,
        following basal cell carcinoma. Following the American Joint Committee on Cancer Tumour, Node
        and Metastasis (TNM) Classification of Malignant Tumors staging system (TNM8), T3 cutaneous
        squamous cell carcinomas comprise an interesting group, especially on the scalp, because of
        the thin subcutaneous fat layer. According to the TNM8 criteria, T3 include all cutaneous
        squamous cel carcinomas with greatest tumor dimension ≥4cm, tumors with minimal bone erosion
        or perineural growth (defined as involvement of the nerve sheath of a nerve lying deeper than
        the dermis or measuring 0.1mm or larger in caliber or showing clinical or radiographic
        involvement of nerves without invasion of the skull base) or with deep invasion. Deep
        invasion is defined as invasion deeper than the subcutaneous fat or a tumor thickness >6mm.
        The scalp has a natural anatomical and oncological barrier for extension in depth known as
        the epicranial aponeurosis, also called the galea aponeurotica.
  
        This retrospective study, examines the tumor- en surgical characteristics of these stage T3
        cutaneous squamous cell carcinomas on the scalp.
  observational model: Cohort
  time perspective: Retrospective
  measure: Surgical characteristics
  time frame: Between 2010-2017
  description: Choice of treatment, complications, reconstruction types
  measure: Tumor characteristics
  time frame: Between 2010-2017
  description: Histological data on invasion depth, tumor differentiation
  measure: Patients characteristics
  time frame: Between 2010-2017
  description: Risk factors, comorbidities
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Nicole Kelleners-Smeets, dr.
  role: Principal Investigator
  affiliation: Maastricht UMC+
  facility: 
  country: Netherlands
  citation: Amin MB, Greene FL, Edge SB, Compton CC, Gershenwald JE, Brookland RK, Meyer L, Gress DM, Byrd DR, Winchester DP. The Eighth Edition AJCC Cancer Staging Manual: Continuing to build a bridge from a population-based to a more "personalized" approach to cancer staging. CA Cancer J Clin. 2017 Mar;67(2):93-99. doi: 10.3322/caac.21388. Epub 2017 Jan 17.
  PMID: 28094848
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Carcinoma, Squamous Cell
  mesh term: Head and Neck Neoplasms