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/NCT06014697</url>
    </required_header>
    <id_info>
      <org_study_id>2023-3735</org_study_id>
      <nct_id>NCT06014697</nct_id>
    </id_info>
    <brief_title>OCT and Invasion in Cutaneous Skin Lesions</brief_title>
    <official_title>The Value of Optical Coherence Tomography in Discrimination Between the Presence and Absence of Invasion in Clinical 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>
        The increasing incidence of actinic keratosis (AK), morbus Bowen (MB) and cutaneous squamous&#xD;
        cell carcinoma (cSCC), the patients with often multiple lesions and the disadvantages of&#xD;
        invasive diagnostics show the need for an accurate non-invasive diagnostic tool for the&#xD;
        determination of invasive growth in AK and MB.&#xD;
  &#xD;
        Optical coherence tomography (OCT) is a non-invasive scanner creating cross-sectional images&#xD;
        of the skin, to a depth of 1-1,5 mm based on light waves. Until now, OCT has been proposed as&#xD;
        non-invasive diagnostic tool for basal cell carcinomas. Although the diagnostic value of OCT&#xD;
        for detection and sub-typing of basal cell carcinomas has already been demonstrated, it is&#xD;
        unclear whether OCT can discriminate between invasive and non-invasive lesions (AK, MB and&#xD;
        cSCCs). There are some studies that describe OCT characteristics of AK, MB and cSCCs,&#xD;
        however, these characteristics have a lot of overlap (8-13). To date there are no clearly&#xD;
        distinctive OCT features to distinguish between AK, MB and cSCCs. This study aims to&#xD;
        investigate the value of OCT in discriminating between the presence and absence of invasion&#xD;
        in lesions with clinical suspicion for invasion.&#xD;
  &#xD;
        Two experienced OCT-assessors will evaluate the OCT scans independently. The OCT assessors&#xD;
        are blinded to the histological diagnosis of the lesions (invasive or non-invasive), which is&#xD;
        used as golden standard.&#xD;
  &#xD;
        A 5-point Likert scale is used for OCT assessment.&#xD;
  &#xD;
          1. Definitely not invasive&#xD;
  &#xD;
          2. Probably not invasive&#xD;
  &#xD;
          3. Unknown, probably invasive/probably not invasive&#xD;
  &#xD;
          4. Probably invasive&#xD;
  &#xD;
          5. Definitely invasive&#xD;
  &#xD;
        In addition to completing the Likert-scale, assessors are asked to describe the&#xD;
        presence/absence of predefined OCT characteristics (a.o. hyperkeratosis and the presence of&#xD;
        the dermo-epidermal junction)&#xD;
  &#xD;
        In case of disagreement between the independent assessors, the OCT scan will be re-assessed&#xD;
        in a consensus meeting.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Anticipated">September 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>Sensitivity</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Sensitivity of OCT to detect invasion</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Specificity</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Specificity of OCT in determining the presence/absence of invasion</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Negative predictive value</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Negative predictive value of OCT in determining the presence/absence of invasion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Positive predictive value</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Positive predictive value of OCT in determining the presence/absence of invasion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the curve</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Area under the curve for OCT in determining the presence/absence of invasion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sensitivity of OCT features</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Sensitivity for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference OCT and clinical practice</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Difference in diagnostic parameters (sensitivity, specificity and area under the curve) between OCT and clinical practice (clinical assessment).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Specificity of OCT features</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Specificity for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Positive predictive value of OCT features</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Positive predictive value for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Negative predictive value of OCT features</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Negative predictive value for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the curve for OCT features</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Area under the curve for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">75</enrollment>
    <condition>Cutaneous Squamous Cell Carcinoma</condition>
    <condition>Bowen's Disease</condition>
    <condition>Actinic Keratoses</condition>
    <condition>Keratosis, Actinic</condition>
    <condition>Diagnosis</condition>
    <arm_group>
      <arm_group_label>Non-invasive lesion</arm_group_label>
      <description>Lesion with histological confirmation of a actinic keratosis or Bowens disease (non-invasive lesions).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Invasive lesion</arm_group_label>
      <description>Lesion with histological confirmation of a squamous cell carcinoma (invasive lesions).</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Optical Coherence Tomography</intervention_name>
      <description>Assessment of the lesion with a non-invasive OCT scan according to a confidence scale (5-point Likert scale: 1 Definitely not invasive, 2 Probably not invasive, 3 Unknown invasive or non-invasive, 4 Probably invasive, 5 Definitely invasive)</description>
      <arm_group_label>Invasive lesion</arm_group_label>
      <arm_group_label>Non-invasive lesion</arm_group_label>
      <other_name>OCT</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Clinical assessment</intervention_name>
      <description>Clinical assessment of the lesion by a dermatologist according to a confidence scale (5-point Likert scale: 1 Definitely not invasive, 2 Probably not invasive, 3 Unknown invasive or non-invasive, 4 Probably invasive, 5 Definitely invasive)</description>
      <arm_group_label>Invasive lesion</arm_group_label>
      <arm_group_label>Non-invasive lesion</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patient with a histologically confirmed actinic keratosis, bowens disease or cutaneous&#xD;
          squamous cell carcinoma, with a clinical differential diagnosis of actinic keratosis and/or&#xD;
          bowens disease and cutaneous squamous cell carcinoma, included in a previous study. All&#xD;
          patients retrospectively had a OCT scan.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who are included in a previous study on OCT, with written informed consent to&#xD;
               use their data regarding OCT.&#xD;
  &#xD;
            -  Patients who retrospectively had an OCT scan for their skin lesion&#xD;
  &#xD;
            -  With a histological confirmed actinic keratosis, bowens disease or cutaneous squamous&#xD;
               cell carcinoma of the skin&#xD;
  &#xD;
            -  with a differential diagnosis of a invasive lesion (cutaneous squamous cell carcinoma)&#xD;
               and a non-invasive lesion (bowens disease or actinic keratosis).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients who waived informed consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</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>
    <link>
      <url>https://www.vivosightatlas.com/</url>
      <description>VivoSight OCT Education Centre. VivoSight. 2022.</description>
    </link>
    <reference>
      <citation>Stratigos AJ, Garbe C, Dessinioti C, Lebbe C, Bataille V, Bastholt L, Dreno B, Fargnoli MC, Forsea AM, Frenard C, Harwood CAlpha, Hauschild A, Hoeller C, Kandolf-Sekulovic L, Kaufmann R, Kelleners-Smeets NW, Malvehy J, Del Marmol V, Middleton MR, Moreno-Ramirez D, Pellecani G, Peris K, Saiag P, van den Beuken-van Everdingen MHJ, Vieira R, Zalaudek I, Eggermont AMM, Grob JJ; European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO) and the European Organization for Research and Treatment of Cancer (EORTC). European interdisciplinary guideline on invasive squamous cell carcinoma of the skin: Part 1. epidemiology, diagnostics and prevention. Eur J Cancer. 2020 Mar;128:60-82. doi: 10.1016/j.ejca.2020.01.007. Epub 2020 Feb 26.</citation>
      <PMID>32113941</PMID>
    </reference>
    <reference>
      <citation>Hollestein LM, de Vries E, Nijsten T. Trends of cutaneous squamous cell carcinoma in the Netherlands: increased incidence rates, but stable relative survival and mortality 1989-2008. Eur J Cancer. 2012 Sep;48(13):2046-53. doi: 10.1016/j.ejca.2012.01.003. Epub 2012 Feb 16.</citation>
      <PMID>22342554</PMID>
    </reference>
    <reference>
      <citation>Lomas A, Leonardi-Bee J, Bath-Hextall F. A systematic review of worldwide incidence of nonmelanoma skin cancer. Br J Dermatol. 2012 May;166(5):1069-80. doi: 10.1111/j.1365-2133.2012.10830.x.</citation>
      <PMID>22251204</PMID>
    </reference>
    <reference>
      <citation>Sinx KAE, van Loo E, Tonk EHJ, Kelleners-Smeets NWJ, Winnepenninckx VJL, Nelemans PJ, Mosterd K. Optical Coherence Tomography for Noninvasive Diagnosis and Subtyping of Basal Cell Carcinoma: A Prospective Cohort Study. J Invest Dermatol. 2020 Oct;140(10):1962-1967. doi: 10.1016/j.jid.2020.01.034. Epub 2020 Mar 6.</citation>
      <PMID>32147505</PMID>
    </reference>
    <reference>
      <citation>Moy RL. Clinical presentation of actinic keratoses and squamous cell carcinoma. J Am Acad Dermatol. 2000 Jan;42(1 Pt 2):8-10. doi: 10.1067/mjd.2000.103343.</citation>
      <PMID>10607350</PMID>
    </reference>
    <reference>
      <citation>Ahmady S, Jansen MHE, Nelemans PJ, Kessels JPHM, Arits AHMM, de Rooij MJM, Essers BAB, Quaedvlieg PJF, Kelleners-Smeets NWJ, Mosterd K. Risk of Invasive Cutaneous Squamous Cell Carcinoma After Different Treatments for Actinic Keratosis: A Secondary Analysis of a Randomized Clinical Trial. JAMA Dermatol. 2022 Jun 1;158(6):634-640. doi: 10.1001/jamadermatol.2022.1034.</citation>
      <PMID>35475852</PMID>
    </reference>
    <reference>
      <citation>Levine A, Wang K, Markowitz O. Optical Coherence Tomography in the Diagnosis of Skin Cancer. Dermatol Clin. 2017 Oct;35(4):465-488. doi: 10.1016/j.det.2017.06.008. Epub 2017 Aug 9.</citation>
      <PMID>28886803</PMID>
    </reference>
    <reference>
      <citation>Sattler E, Kastle R, Welzel J. Optical coherence tomography in dermatology. J Biomed Opt. 2013 Jun;18(6):061224. doi: 10.1117/1.JBO.18.6.061224.</citation>
      <PMID>23314617</PMID>
    </reference>
    <reference>
      <citation>Boone MA, Marneffe A, Suppa M, Miyamoto M, Alarcon I, Hofmann-Wellenhof R, Malvehy J, Pellacani G, Del Marmol V. High-definition optical coherence tomography algorithm for the discrimination of actinic keratosis from normal skin and from squamous cell carcinoma. J Eur Acad Dermatol Venereol. 2015 Aug;29(8):1606-15. doi: 10.1111/jdv.12954. Epub 2015 Feb 5.</citation>
      <PMID>25656269</PMID>
    </reference>
    <reference>
      <citation>Marneffe A, Suppa M, Miyamoto M, Del Marmol V, Boone M. Validation of a diagnostic algorithm for the discrimination of actinic keratosis from normal skin and squamous cell carcinoma by means of high-definition optical coherence tomography. Exp Dermatol. 2016 Sep;25(9):684-7. doi: 10.1111/exd.13036.</citation>
      <PMID>27095632</PMID>
    </reference>
    <reference>
      <citation>Friis KBE, Themstrup L, Jemec GBE. Optical coherence tomography in the diagnosis of actinic keratosis-A systematic review. Photodiagnosis Photodyn Ther. 2017 Jun;18:98-104. doi: 10.1016/j.pdpdt.2017.02.003. Epub 2017 Feb 7.</citation>
      <PMID>28188920</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Optical coherence tomography</keyword>
    <keyword>Invasion</keyword>
    <keyword>Diagnostic device</keyword>
    <keyword>Non-invasive</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Keratosis, Actinic</mesh_term>
      <mesh_term>Bowen's Disease</mesh_term>
      <mesh_term>Keratosis</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/NCT06014697
  org study id: 2023-3735
  nct id: NCT06014697
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The increasing incidence of actinic keratosis (AK), morbus Bowen (MB) and cutaneous squamous
        cell carcinoma (cSCC), the patients with often multiple lesions and the disadvantages of
        invasive diagnostics show the need for an accurate non-invasive diagnostic tool for the
        determination of invasive growth in AK and MB.
  
        Optical coherence tomography (OCT) is a non-invasive scanner creating cross-sectional images
        of the skin, to a depth of 1-1,5 mm based on light waves. Until now, OCT has been proposed as
        non-invasive diagnostic tool for basal cell carcinomas. Although the diagnostic value of OCT
        for detection and sub-typing of basal cell carcinomas has already been demonstrated, it is
        unclear whether OCT can discriminate between invasive and non-invasive lesions (AK, MB and
        cSCCs). There are some studies that describe OCT characteristics of AK, MB and cSCCs,
        however, these characteristics have a lot of overlap (8-13). To date there are no clearly
        distinctive OCT features to distinguish between AK, MB and cSCCs. This study aims to
        investigate the value of OCT in discriminating between the presence and absence of invasion
        in lesions with clinical suspicion for invasion.
  
        Two experienced OCT-assessors will evaluate the OCT scans independently. The OCT assessors
        are blinded to the histological diagnosis of the lesions (invasive or non-invasive), which is
        used as golden standard.
  
        A 5-point Likert scale is used for OCT assessment.
  
          1. Definitely not invasive
  
          2. Probably not invasive
  
          3. Unknown, probably invasive/probably not invasive
  
          4. Probably invasive
  
          5. Definitely invasive
  
        In addition to completing the Likert-scale, assessors are asked to describe the
        presence/absence of predefined OCT characteristics (a.o. hyperkeratosis and the presence of
        the dermo-epidermal junction)
  
        In case of disagreement between the independent assessors, the OCT scan will be re-assessed
        in a consensus meeting.
  observational model: Cohort
  time perspective: Prospective
  measure: Sensitivity
  time frame: Through study completion, an average of 6 months
  description: Sensitivity of OCT to detect invasion
  measure: Specificity
  time frame: Through study completion, an average of 6 months
  description: Specificity of OCT in determining the presence/absence of invasion
  measure: Negative predictive value
  time frame: Through study completion, an average of 6 months
  description: Negative predictive value of OCT in determining the presence/absence of invasion
  measure: Positive predictive value
  time frame: Through study completion, an average of 6 months
  description: Positive predictive value of OCT in determining the presence/absence of invasion
  measure: Area under the curve
  time frame: Through study completion, an average of 6 months
  description: Area under the curve for OCT in determining the presence/absence of invasion
  measure: Sensitivity of OCT features
  time frame: Through study completion, an average of 6 months
  description: Sensitivity for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis.
  measure: Difference OCT and clinical practice
  time frame: Through study completion, an average of 6 months
  description: Difference in diagnostic parameters (sensitivity, specificity and area under the curve) between OCT and clinical practice (clinical assessment).
  measure: Specificity of OCT features
  time frame: Through study completion, an average of 6 months
  description: Specificity for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis.
  measure: Positive predictive value of OCT features
  time frame: Through study completion, an average of 6 months
  description: Positive predictive value for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis.
  measure: Negative predictive value of OCT features
  time frame: Through study completion, an average of 6 months
  description: Negative predictive value for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis.
  measure: Area under the curve for OCT features
  time frame: Through study completion, an average of 6 months
  description: Area under the curve for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis.
  arm group label: Non-invasive lesion
  description: Lesion with histological confirmation of a actinic keratosis or Bowens disease (non-invasive lesions).
  arm group label: Invasive lesion
  description: Lesion with histological confirmation of a squamous cell carcinoma (invasive lesions).
  intervention type: Diagnostic Test
  intervention name: Optical Coherence Tomography
  description: Assessment of the lesion with a non-invasive OCT scan according to a confidence scale (5-point Likert scale: 1 Definitely not invasive, 2 Probably not invasive, 3 Unknown invasive or non-invasive, 4 Probably invasive, 5 Definitely invasive)
  arm group label: Invasive lesion
  arm group label: Non-invasive lesion
  other name: OCT
  intervention type: Other
  intervention name: Clinical assessment
  description: Clinical assessment of the lesion by a dermatologist according to a confidence scale (5-point Likert scale: 1 Definitely not invasive, 2 Probably not invasive, 3 Unknown invasive or non-invasive, 4 Probably invasive, 5 Definitely invasive)
  arm group label: Invasive lesion
  arm group label: Non-invasive lesion
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: K Mosterd, MD, PhD
  role: Principal Investigator
  affiliation: Maastricht University Medical Center
  facility: 
  country: Netherlands
  url: https://www.vivosightatlas.com/
  description: VivoSight OCT Education Centre. VivoSight. 2022.
  citation: Stratigos AJ, Garbe C, Dessinioti C, Lebbe C, Bataille V, Bastholt L, Dreno B, Fargnoli MC, Forsea AM, Frenard C, Harwood CAlpha, Hauschild A, Hoeller C, Kandolf-Sekulovic L, Kaufmann R, Kelleners-Smeets NW, Malvehy J, Del Marmol V, Middleton MR, Moreno-Ramirez D, Pellecani G, Peris K, Saiag P, van den Beuken-van Everdingen MHJ, Vieira R, Zalaudek I, Eggermont AMM, Grob JJ; European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO) and the European Organization for Research and Treatment of Cancer (EORTC). European interdisciplinary guideline on invasive squamous cell carcinoma of the skin: Part 1. epidemiology, diagnostics and prevention. Eur J Cancer. 2020 Mar;128:60-82. doi: 10.1016/j.ejca.2020.01.007. Epub 2020 Feb 26.
  PMID: 32113941
  citation: Hollestein LM, de Vries E, Nijsten T. Trends of cutaneous squamous cell carcinoma in the Netherlands: increased incidence rates, but stable relative survival and mortality 1989-2008. Eur J Cancer. 2012 Sep;48(13):2046-53. doi: 10.1016/j.ejca.2012.01.003. Epub 2012 Feb 16.
  PMID: 22342554
  citation: Lomas A, Leonardi-Bee J, Bath-Hextall F. A systematic review of worldwide incidence of nonmelanoma skin cancer. Br J Dermatol. 2012 May;166(5):1069-80. doi: 10.1111/j.1365-2133.2012.10830.x.
  PMID: 22251204
  citation: Sinx KAE, van Loo E, Tonk EHJ, Kelleners-Smeets NWJ, Winnepenninckx VJL, Nelemans PJ, Mosterd K. Optical Coherence Tomography for Noninvasive Diagnosis and Subtyping of Basal Cell Carcinoma: A Prospective Cohort Study. J Invest Dermatol. 2020 Oct;140(10):1962-1967. doi: 10.1016/j.jid.2020.01.034. Epub 2020 Mar 6.
  PMID: 32147505
  citation: Moy RL. Clinical presentation of actinic keratoses and squamous cell carcinoma. J Am Acad Dermatol. 2000 Jan;42(1 Pt 2):8-10. doi: 10.1067/mjd.2000.103343.
  PMID: 10607350
  citation: Ahmady S, Jansen MHE, Nelemans PJ, Kessels JPHM, Arits AHMM, de Rooij MJM, Essers BAB, Quaedvlieg PJF, Kelleners-Smeets NWJ, Mosterd K. Risk of Invasive Cutaneous Squamous Cell Carcinoma After Different Treatments for Actinic Keratosis: A Secondary Analysis of a Randomized Clinical Trial. JAMA Dermatol. 2022 Jun 1;158(6):634-640. doi: 10.1001/jamadermatol.2022.1034.
  PMID: 35475852
  citation: Levine A, Wang K, Markowitz O. Optical Coherence Tomography in the Diagnosis of Skin Cancer. Dermatol Clin. 2017 Oct;35(4):465-488. doi: 10.1016/j.det.2017.06.008. Epub 2017 Aug 9.
  PMID: 28886803
  citation: Sattler E, Kastle R, Welzel J. Optical coherence tomography in dermatology. J Biomed Opt. 2013 Jun;18(6):061224. doi: 10.1117/1.JBO.18.6.061224.
  PMID: 23314617
  citation: Boone MA, Marneffe A, Suppa M, Miyamoto M, Alarcon I, Hofmann-Wellenhof R, Malvehy J, Pellacani G, Del Marmol V. High-definition optical coherence tomography algorithm for the discrimination of actinic keratosis from normal skin and from squamous cell carcinoma. J Eur Acad Dermatol Venereol. 2015 Aug;29(8):1606-15. doi: 10.1111/jdv.12954. Epub 2015 Feb 5.
  PMID: 25656269
  citation: Marneffe A, Suppa M, Miyamoto M, Del Marmol V, Boone M. Validation of a diagnostic algorithm for the discrimination of actinic keratosis from normal skin and squamous cell carcinoma by means of high-definition optical coherence tomography. Exp Dermatol. 2016 Sep;25(9):684-7. doi: 10.1111/exd.13036.
  PMID: 27095632
  citation: Friis KBE, Themstrup L, Jemec GBE. Optical coherence tomography in the diagnosis of actinic keratosis-A systematic review. Photodiagnosis Photodyn Ther. 2017 Jun;18:98-104. doi: 10.1016/j.pdpdt.2017.02.003. Epub 2017 Feb 7.
  PMID: 28188920
  responsible party type: Sponsor
  mesh term: Keratosis, Actinic
  mesh term: Bowen's Disease
  mesh term: Keratosis
  sharing ipd: Undecided