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/NCT06024629</url>
    </required_header>
    <id_info>
      <org_study_id>2023-0086</org_study_id>
      <nct_id>NCT06024629</nct_id>
    </id_info>
    <brief_title>cOCT Versus LC-OCT for Diagnosing Basal Cell Carcinoma: a Diagnostic Cohort Study</brief_title>
    <official_title>cOCT Versus LC-OCT for Diagnosing Basal Cell Carcinoma: a Diagnostic Cohort Study</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>
        Basal cell carcinoma (BCC) is the most common form of cancer among the Caucasian population.&#xD;
        Equivocal BCC lesions are usually diagnosed by means of a punch biopsy, but since the last&#xD;
        few decades, non-invasive imaging techniques for the diagnosis of BCC gained popularity&#xD;
        within the field of dermatology. Conventional optical coherence tomography (cOCT) is an&#xD;
        example of a non-invasive imaging technique. Recent studies revealed that OCT assessors may&#xD;
        achieve high diagnostic certainty and accuracy for diagnosing BCC. However, cOCT has a&#xD;
        limited axial and lateral resolution and can therefore only visualize the gross architecture&#xD;
        of the skin. It has been proposed that the diagnostic certainty and accuracy of cOCT could be&#xD;
        optimized by improving the resolution. Line-field confocal optical coherence tomography&#xD;
        (LC-OCT) is a new non-invasive imaging technique that provides tridimensional images of the&#xD;
        skin with a cellular resolution. Although the resolution of LC-OCT is superior to cOCT, the&#xD;
        penetration depth of LC-OCT (500µm) is limited compared to that of cOCT (1.0-1.5mm). In the&#xD;
        proposed study, we aim to assess whether LC-OCT is superior to cOCT in terms of diagnostic&#xD;
        accuracy for diagnosing BCC in equivocal BCC lesions.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</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>Diagnostic accuracy of cOCT and LC-OCT</measure>
      <time_frame>Measured before september 1st 2024</time_frame>
      <description>Diagnostic parameters such as sensitivity, specificity, PPV, NPV and DOR will be evaluated for diagnosing BCC in patients with equivocal lesions and compared between both imaging devices.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Diagnostic accuracy for BCC subtyping on cOCT and LC-OCT</measure>
      <time_frame>Measured before september 1st 2024</time_frame>
      <description>Diagnostic parameter for differentiating BCC subtypes (sBCC/nBCC/iBCC) will be evaluated and compared between both imaging devices.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">197</enrollment>
    <condition>Basal Cell Carcinoma</condition>
    <arm_group>
      <arm_group_label>Patients with equivocal BCC lesions</arm_group_label>
      <description>Patients with equivocal BCC lesions (18+ years) who will undergo biopsy conform regular care will undergo a cOCT and LC-OCT scan.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>cOCT and LC-OCT</intervention_name>
      <description>cOCT: conventional optical coherence tomography (cOCT) is an established imaging modality within dermatology that enables visualization of the architecture of the skin with a penetration depth of 1.0 - 1.5mm.&#xD;
  LC-OCT: Line-field confocal optical coherence tomography (LC-OCT) is a new emerging diagnostic modality within the field of dermatology. LC-OCT enables tridimensional imaging of the skin with a cellular resolution and BCC features on LC-OCT have been described. However, the penetration depth of LC-OCT (500µm), is limited compared to the penetration depth of cOCT (1.0-1.5mm)</description>
      <arm_group_label>Patients with equivocal BCC lesions</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study population will consist of patients visiting the outpatient clinic of Maastricht&#xD;
          University Medical Center+ (MUMC+). All included patients (18+) will undergo a punch&#xD;
          biopsie for their equivocal BCC lesion conform regular care.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients (18+) with equivocal BCC lesions undergoing biopsy conform regular care&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients unable to sign informed consent&#xD;
  &#xD;
            -  Patients with clinically evident BCC lesions who do not undergo biopsy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 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">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Optical coherence tomography</keyword>
    <keyword>Line-field confocal optical coherence tomography</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Carcinoma, Basal Cell</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>IPD may be shared upon reasonable request</ipd_description>
    </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/NCT06024629
  org study id: 2023-0086
  nct id: NCT06024629
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Basal cell carcinoma (BCC) is the most common form of cancer among the Caucasian population.
        Equivocal BCC lesions are usually diagnosed by means of a punch biopsy, but since the last
        few decades, non-invasive imaging techniques for the diagnosis of BCC gained popularity
        within the field of dermatology. Conventional optical coherence tomography (cOCT) is an
        example of a non-invasive imaging technique. Recent studies revealed that OCT assessors may
        achieve high diagnostic certainty and accuracy for diagnosing BCC. However, cOCT has a
        limited axial and lateral resolution and can therefore only visualize the gross architecture
        of the skin. It has been proposed that the diagnostic certainty and accuracy of cOCT could be
        optimized by improving the resolution. Line-field confocal optical coherence tomography
        (LC-OCT) is a new non-invasive imaging technique that provides tridimensional images of the
        skin with a cellular resolution. Although the resolution of LC-OCT is superior to cOCT, the
        penetration depth of LC-OCT (500µm) is limited compared to that of cOCT (1.0-1.5mm). In the
        proposed study, we aim to assess whether LC-OCT is superior to cOCT in terms of diagnostic
        accuracy for diagnosing BCC in equivocal BCC lesions.
  observational model: Cohort
  time perspective: Retrospective
  measure: Diagnostic accuracy of cOCT and LC-OCT
  time frame: Measured before september 1st 2024
  description: Diagnostic parameters such as sensitivity, specificity, PPV, NPV and DOR will be evaluated for diagnosing BCC in patients with equivocal lesions and compared between both imaging devices.
  measure: Diagnostic accuracy for BCC subtyping on cOCT and LC-OCT
  time frame: Measured before september 1st 2024
  description: Diagnostic parameter for differentiating BCC subtypes (sBCC/nBCC/iBCC) will be evaluated and compared between both imaging devices.
  arm group label: Patients with equivocal BCC lesions
  description: Patients with equivocal BCC lesions (18+ years) who will undergo biopsy conform regular care will undergo a cOCT and LC-OCT scan.
  intervention type: Device
  intervention name: cOCT and LC-OCT
  description: cOCT: conventional optical coherence tomography (cOCT) is an established imaging modality within dermatology that enables visualization of the architecture of the skin with a penetration depth of 1.0 - 1.5mm.
  LC-OCT: Line-field confocal optical coherence tomography (LC-OCT) is a new emerging diagnostic modality within the field of dermatology. LC-OCT enables tridimensional imaging of the skin with a cellular resolution and BCC features on LC-OCT have been described. However, the penetration depth of LC-OCT (500µm), is limited compared to the penetration depth of cOCT (1.0-1.5mm)
  arm group label: Patients with equivocal BCC lesions
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Carcinoma, Basal Cell
  sharing ipd: Undecided
  ipd description: IPD may be shared upon reasonable request