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/NCT06020612</url>
    </required_header>
    <id_info>
      <org_study_id>2023-3752</org_study_id>
      <nct_id>NCT06020612</nct_id>
    </id_info>
    <brief_title>Interobserver Variability Desmoplasia</brief_title>
    <official_title>Desmoplasia in Cutaneous Squamous Cell Carcinoma: Inter Observer Agreement Between Dermatopathologists.</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>
        According to the most recent guideline of the National Comprehensive Cancer Network (NCCN),&#xD;
        desmoplasia is considered to be a very high risk factor for recurrence, metastasis and death&#xD;
        in cutaneous squamous cell carcinoma (cSCC). The presence of desmoplasia is assessed by&#xD;
        dermatopathologists during histological examination of cSCCs. However, the inter-observer&#xD;
        agreement is between dermatopathologists in the assessment of desmoplasia is unclear. Studies&#xD;
        on inter-observer variability in the assessment of differentiation grade in cSCCs showed that&#xD;
        there is only a weak to moderate agreement among dermatopathologists in the assessment of&#xD;
        differentiation grade (2-4). This study aims to investigate the interobserver agreement of&#xD;
        desmoplasia between dermatopathologists. In this prospective study, 50 cSCCs will be assessed&#xD;
        for desmoplasia by at least eight dermatopathologists using a predefined definition.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">October 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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Interobserver agreement</measure>
      <time_frame>Through study completion, an average of 2 months</time_frame>
      <description>Interobserver agreement between dermatopathologists in the assessment of desmoplasia, expressed as percentages and Fleiss' kappa (Landis and Koch, see below) &lt;0 Poor agreement 0.0-0.20 Slight agreement 0.21-0.40 Fair agreement 0.41-0.60 Moderate agreement 0.61-0.80 Substantial agreement 0.81-1.00 Almost perfect agreement</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Definitions used</measure>
      <time_frame>Before the histological assessment, at baseline.</time_frame>
      <description>A description of the different definitions of desmoplasia used by the dermatopathologists.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">50</enrollment>
    <condition>Cutaneous Squamous Cell Carcinoma</condition>
    <condition>Pathology</condition>
    <condition>Recurrence</condition>
    <condition>Metastasis</condition>
    <arm_group>
      <arm_group_label>Presence of desmoplasia</arm_group_label>
      <description>Tumors with presence of desmoplasia according to the predefined definition.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Absence of desmoplasia</arm_group_label>
      <description>Tumors in absence of desmoplasia according to the predefined definition.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Assessment by dermatopathologists</intervention_name>
      <description>Histological assessment of the cSCCs by eight dermatopathologists.</description>
      <arm_group_label>Absence of desmoplasia</arm_group_label>
      <arm_group_label>Presence of desmoplasia</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study population consists of adult patients, both male and female, who were treated at&#xD;
          MUMC+ between 2010 and 2018 for a cSCC, with and without desmoplasia, and whose histology&#xD;
          is available.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Histological coupes of patients with a cSCC between 2010 and 2018 (both cSCC with and&#xD;
               without desmoplasia are included)&#xD;
  &#xD;
            -  Treated at the Maastricht University Medical Center+ (MUMC+)in Maastricht for their&#xD;
               cSCC&#xD;
  &#xD;
            -  Of which the histology is available in the MUMC+&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - None&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>K Mosterd, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Maastricht University Medical Center</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Maastricht University Medical Center+</name>
        <address>
          <city>Maastricht</city>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <reference>
      <citation>National Comprehensive Cancer Network. Squamous Cell Skin Cancer (Version 2.2022) May 2, 2022. Retrieved from https://www.nccn.org/professionals/physician_gls/pdf/squamous.pdf</citation>
    </reference>
    <reference>
      <citation>Prezzano JC, Scott GA, Lambert Smith F, Mannava KA, Ibrahim SF. Concordance of Squamous Cell Carcinoma Histologic Grading Among Dermatopathologists and Mohs Surgeons. Dermatol Surg. 2021 Nov 1;47(11):1433-1437. doi: 10.1097/DSS.0000000000003213.</citation>
      <PMID>34482328</PMID>
    </reference>
    <reference>
      <citation>Fujimoto M, Yamamoto Y, Takai T, Fujimoto N, Ogawa K, Yoshikawa T, Matsuzaki I, Takahashi Y, Iwahashi Y, Warigaya K, Kojima F, Jinnin M, Murata SI. Tumor Budding Is an Objective High-risk Factor Associated With Metastasis and Poor Clinical Prognosis in Cutaneous Squamous Cell Carcinoma Sized &lt;4 cm. Am J Surg Pathol. 2019 Jul;43(7):975-983. doi: 10.1097/PAS.0000000000001284.</citation>
      <PMID>31094931</PMID>
    </reference>
    <reference>
      <citation>Nash J, Shahwan KT, Chung C, Abidi N, Gokun Y, Pan X, Carr DR. Grading of differentiation in cutaneous squamous cell carcinoma: Evaluation of interrater and intrarater reliability. J Am Acad Dermatol. 2022 Oct;87(4):895-897. doi: 10.1016/j.jaad.2021.12.015. Epub 2021 Dec 15. No abstract available.</citation>
      <PMID>34920027</PMID>
    </reference>
    <reference>
      <citation>Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.</citation>
      <PMID>843571</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 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>
    <keyword>Interobserver variability</keyword>
    <keyword>Interobserver agreement</keyword>
    <keyword>Reproducibility</keyword>
    <keyword>Dermatopathologist</keyword>
    <keyword>Desmoplasia</keyword>
    <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>Recurrence</mesh_term>
      <mesh_term>Fibrosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06020612
  org study id: 2023-3752
  nct id: NCT06020612
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  According to the most recent guideline of the National Comprehensive Cancer Network (NCCN),
        desmoplasia is considered to be a very high risk factor for recurrence, metastasis and death
        in cutaneous squamous cell carcinoma (cSCC). The presence of desmoplasia is assessed by
        dermatopathologists during histological examination of cSCCs. However, the inter-observer
        agreement is between dermatopathologists in the assessment of desmoplasia is unclear. Studies
        on inter-observer variability in the assessment of differentiation grade in cSCCs showed that
        there is only a weak to moderate agreement among dermatopathologists in the assessment of
        differentiation grade (2-4). This study aims to investigate the interobserver agreement of
        desmoplasia between dermatopathologists. In this prospective study, 50 cSCCs will be assessed
        for desmoplasia by at least eight dermatopathologists using a predefined definition.
  observational model: Cohort
  time perspective: Prospective
  measure: Interobserver agreement
  time frame: Through study completion, an average of 2 months
  description: Interobserver agreement between dermatopathologists in the assessment of desmoplasia, expressed as percentages and Fleiss' kappa (Landis and Koch, see below) <0 Poor agreement 0.0-0.20 Slight agreement 0.21-0.40 Fair agreement 0.41-0.60 Moderate agreement 0.61-0.80 Substantial agreement 0.81-1.00 Almost perfect agreement
  measure: Definitions used
  time frame: Before the histological assessment, at baseline.
  description: A description of the different definitions of desmoplasia used by the dermatopathologists.
  arm group label: Presence of desmoplasia
  description: Tumors with presence of desmoplasia according to the predefined definition.
  arm group label: Absence of desmoplasia
  description: Tumors in absence of desmoplasia according to the predefined definition.
  intervention type: Other
  intervention name: Assessment by dermatopathologists
  description: Histological assessment of the cSCCs by eight dermatopathologists.
  arm group label: Absence of desmoplasia
  arm group label: Presence of desmoplasia
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: N/A
  healthy volunteers: No
  last name: K Mosterd, MD, PhD
  role: Principal Investigator
  affiliation: Maastricht University Medical Center
  facility: 
  country: Netherlands
  citation: National Comprehensive Cancer Network. Squamous Cell Skin Cancer (Version 2.2022) May 2, 2022. Retrieved from https://www.nccn.org/professionals/physician_gls/pdf/squamous.pdf
  citation: Prezzano JC, Scott GA, Lambert Smith F, Mannava KA, Ibrahim SF. Concordance of Squamous Cell Carcinoma Histologic Grading Among Dermatopathologists and Mohs Surgeons. Dermatol Surg. 2021 Nov 1;47(11):1433-1437. doi: 10.1097/DSS.0000000000003213.
  PMID: 34482328
  citation: Fujimoto M, Yamamoto Y, Takai T, Fujimoto N, Ogawa K, Yoshikawa T, Matsuzaki I, Takahashi Y, Iwahashi Y, Warigaya K, Kojima F, Jinnin M, Murata SI. Tumor Budding Is an Objective High-risk Factor Associated With Metastasis and Poor Clinical Prognosis in Cutaneous Squamous Cell Carcinoma Sized <4 cm. Am J Surg Pathol. 2019 Jul;43(7):975-983. doi: 10.1097/PAS.0000000000001284.
  PMID: 31094931
  citation: Nash J, Shahwan KT, Chung C, Abidi N, Gokun Y, Pan X, Carr DR. Grading of differentiation in cutaneous squamous cell carcinoma: Evaluation of interrater and intrarater reliability. J Am Acad Dermatol. 2022 Oct;87(4):895-897. doi: 10.1016/j.jaad.2021.12.015. Epub 2021 Dec 15. No abstract available.
  PMID: 34920027
  citation: Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.
  PMID: 843571
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Carcinoma, Squamous Cell
  mesh term: Recurrence
  mesh term: Fibrosis
  sharing ipd: Undecided