<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/NCT04491825</url>
  </required_header>
  <id_info>
    <org_study_id>CTCL_Classifier_KLIF</org_study_id>
    <nct_id>NCT04491825</nct_id>
  </id_info>
  <brief_title>Diagnostic Classifier for Cutaneous T-cell Lymphomas</brief_title>
  <official_title>Diagnostic Classifier for Cutaneous T-cell Lymphomas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</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>
      Primary cutaneous T-cell lymphomas (CTCL) are a form of skin cancer that is derived from&#xD;
      immune cells. The most common form of CTCL is mycosis fungoides (MF). While initially&#xD;
      confined to the skin, MF may spread to lymph nodes, blood or inner organs, resulting in an&#xD;
      overall poor prognosis for the patient. Thus, being a potentially lethal disease, an early&#xD;
      and correct diagnosis of MF has very important implications for the patient. However,&#xD;
      diagnosis of early MF is often difficult, as it usually shows a close resemblance to benign&#xD;
      inflammatory conditions such as eczema and psoriasis. Strikingly, it takes an average of 3-6&#xD;
      (!) years from the appearance of the first skin lesions until a diagnosis of MF can be made.&#xD;
      For this reason, a test to distinguishing early MF from benign inflammatory conditions is&#xD;
      urgently mandated. By using skin suction blister fluid as well as skin biopsies from patients&#xD;
      with MF, eczema and psoriasis, the investigators want to develop a classifier system that can&#xD;
      distinguish early MF from benign inflammatory skin diseases.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 22, 2021</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 22, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proteomic signature of MF in comparison to eczema, psoriasis, and healthy control skin</measure>
    <time_frame>At baseline</time_frame>
    <description>Proteomic multiplex assay</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">160</enrollment>
  <condition>CTCL/ Mycosis Fungoides</condition>
  <arm_group>
    <arm_group_label>Mycosis fungoides (MF)</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Eczema (Atopic Dermatitis)</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic Plaque-Psoriasis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Control Skin</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Skin suction blistering and skin biopsies</intervention_name>
    <description>Skin suction blistering and skin biopsies will be used for the identification of potential proteomic biomarkers that can distinguish MF from eczema, psoriasis and healthy control skin.</description>
    <arm_group_label>Chronic Plaque-Psoriasis</arm_group_label>
    <arm_group_label>Eczema (Atopic Dermatitis)</arm_group_label>
    <arm_group_label>Healthy Control Skin</arm_group_label>
    <arm_group_label>Mycosis fungoides (MF)</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Suction blister fluid and skin biopsies.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        MF patients need prior histopathological verification of their disease.&#xD;
&#xD;
        Eczema and psoriasis patients will be diagnosed clinically and, if necessary, on a&#xD;
        histopathological basis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical and/or histopathological diagnosis of MF, eczema or psoriasis&#xD;
&#xD;
          -  Healthy control subjects without personal history of MF, eczema or psoriasis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ongoing skin-targeted treatment (Wash out times: 2 weeks for topical, and 4 weeks for&#xD;
             systemic treatments)&#xD;
&#xD;
          -  Ongoing other treatment that might, in the opinion of the investigator, influence&#xD;
             proteomic features of the samples to be acquired&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Patrick M Brunner, MD, MSc</last_name>
    <phone>+43140400</phone>
    <phone_ext>77020</phone_ext>
    <email>patrick.brunner@meduniwien.ac.at</email>
  </overall_contact>
  <location>
    <facility>
      <name>Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick Brunner, MD, MSc</last_name>
      <phone>+436644605954</phone>
      <email>patrick.brunner@meduniwien.ac.at</email>
    </contact>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>April 4, 2022</last_update_submitted>
  <last_update_submitted_qc>April 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Patrick M. Brunner</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mycoses</mesh_term>
    <mesh_term>Lymphoma, T-Cell</mesh_term>
    <mesh_term>Mycosis Fungoides</mesh_term>
    <mesh_term>Lymphoma, T-Cell, Cutaneous</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04491825
org study id: CTCL_Classifier_KLIF
nct id: NCT04491825
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Primary cutaneous T-cell lymphomas (CTCL) are a form of skin cancer that is derived from
      immune cells. The most common form of CTCL is mycosis fungoides (MF). While initially
      confined to the skin, MF may spread to lymph nodes, blood or inner organs, resulting in an
      overall poor prognosis for the patient. Thus, being a potentially lethal disease, an early
      and correct diagnosis of MF has very important implications for the patient. However,
      diagnosis of early MF is often difficult, as it usually shows a close resemblance to benign
      inflammatory conditions such as eczema and psoriasis. Strikingly, it takes an average of 3-6
      (!) years from the appearance of the first skin lesions until a diagnosis of MF can be made.
      For this reason, a test to distinguishing early MF from benign inflammatory conditions is
      urgently mandated. By using skin suction blister fluid as well as skin biopsies from patients
      with MF, eczema and psoriasis, the investigators want to develop a classifier system that can
      distinguish early MF from benign inflammatory skin diseases.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Proteomic signature of MF in comparison to eczema, psoriasis, and healthy control skin
time frame: At baseline
description: Proteomic multiplex assay
arm group label: Mycosis fungoides (MF)
arm group label: Eczema (Atopic Dermatitis)
arm group label: Chronic Plaque-Psoriasis
arm group label: Healthy Control Skin
intervention type: Diagnostic Test
intervention name: Skin suction blistering and skin biopsies
description: Skin suction blistering and skin biopsies will be used for the identification of potential proteomic biomarkers that can distinguish MF from eczema, psoriasis and healthy control skin.
arm group label: Chronic Plaque-Psoriasis
arm group label: Eczema (Atopic Dermatitis)
arm group label: Healthy Control Skin
arm group label: Mycosis fungoides (MF)
Suction blister fluid and skin biopsies.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
last name: Patrick M Brunner, MD, MSc
phone: +43140400
phone ext: 77020
email: patrick.brunner@meduniwien.ac.at
facility: 
status: Recruiting
contact: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Patrick M. Brunner
investigator title: Associate Professor
mesh term: Mycoses
mesh term: Lymphoma, T-Cell
mesh term: Mycosis Fungoides
mesh term: Lymphoma, T-Cell, Cutaneous