<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/NCT04400578</url>
  </required_header>
  <id_info>
    <org_study_id>EKS 48/19</org_study_id>
    <nct_id>NCT04400578</nct_id>
  </id_info>
  <brief_title>TRICIN: Prospective Study on the Efficacy of Single Topical Trichloroacetic Acid (TCA) 85% in the Treatment of Cervical Intraepithelial Neoplasia (CIN 1/2)</brief_title>
  <acronym>TRICIN</acronym>
  <official_title>TRICIN: Prospective Study on the Efficacy of Single Topical Trichloroacetic Acid (TCA) 85% in the Treatment of Cervical Intraepithelial Neoplasia (CIN 1/2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Krankenhaus Barmherzige Schwestern Linz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Krankenhaus Barmherzige Schwestern Linz</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Trichloroacetic acid 85% =TCA is an investigational device intended to achieve a complete&#xD;
      histologic remission in individuals with cervical intraepithelial neoplasia (CIN) grade 1/2.&#xD;
      The device system is to be used only in accordance with the approved Investigational Plan on&#xD;
      subjects, who have given written informed consent.&#xD;
&#xD;
      High remission and regression rates are expected after a single topical treatment with 85%&#xD;
      TCA. After a single topical treatment with 85% TCA for CIN 1-2 (Expected 70% or higher; null&#xD;
      hypothesis: not higher than 55%). Regression is defined as improvement from high grade lesion&#xD;
      (CIN 2) at baseline to low grade lesion (CIN 1) after TCA treatment. Regression from CIN 1&#xD;
      normal squamous epithelium after the TCA treatment is equal to remission and will be counted&#xD;
      as a remission in combined analysis. Remission is defined as complete histologic remission of&#xD;
      CIN back to normal squamous epithelium after the TCA treatment, i.e., no cervical dysplasia&#xD;
      is detectable by histology or cytology after the TCA treatment. Type-specific HPV Clearance&#xD;
      is defined as disappearance of the HPV type detected at screening.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Visit and assessment Schedule:&#xD;
&#xD;
      Visit1 Screening:&#xD;
&#xD;
        -  Informed Consent,&#xD;
&#xD;
        -  Inclusion/Exclusion Criteria,&#xD;
&#xD;
        -  Medical History,&#xD;
&#xD;
        -  Gynecological Examination&#xD;
&#xD;
        -  Cytology&#xD;
&#xD;
        -  HPV Test&#xD;
&#xD;
        -  Colposcopy&#xD;
&#xD;
        -  Biopsy&#xD;
&#xD;
        -  VAS (Visual analog scale)&#xD;
&#xD;
        -  Pregnancy test&#xD;
&#xD;
      Visit 2 Treatment Day with TCA 85%:&#xD;
&#xD;
        -  Colposcopy&#xD;
&#xD;
        -  TCA Treatment&#xD;
&#xD;
        -  VAS&#xD;
&#xD;
        -  Pregnancy test&#xD;
&#xD;
      Visit 3, Control 1, Week 10-14:&#xD;
&#xD;
        -  Cytology&#xD;
&#xD;
        -  HPV Test&#xD;
&#xD;
        -  Colposcopy&#xD;
&#xD;
        -  Biopsy&#xD;
&#xD;
        -  4-quadrant biopsy&#xD;
&#xD;
        -  ECC&#xD;
&#xD;
        -  Adverse event monitoring If there is no sign of CIN during the colposcopic examination&#xD;
           10-14 weeks a 4-quadrant biopsy and a ECC are performed&#xD;
&#xD;
      Visit 4, Control 2, Week 22-26:&#xD;
&#xD;
        -  Cytology&#xD;
&#xD;
        -  HPV Test&#xD;
&#xD;
        -  Colposcopy&#xD;
&#xD;
        -  Biopsy&#xD;
&#xD;
        -  4-quadrant biopsy&#xD;
&#xD;
        -  ECC&#xD;
&#xD;
        -  Adverse event monitoring&#xD;
&#xD;
        -  Pregnancy test If there is no sign of CIN during the colposcopic examination 22-26 weeks&#xD;
           after the TCA treatment, a 4-quadrant biopsy and a ECC are performed.&#xD;
&#xD;
      Visit 5, EOS , Week 24-30:&#xD;
&#xD;
      - Results Discussion&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 7, 2020</start_date>
  <completion_date type="Actual">January 18, 2022</completion_date>
  <primary_completion_date type="Actual">January 18, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CIN remission rate after treatment with TCA 85%</measure>
    <time_frame>6 months</time_frame>
    <description>measured by histologic remission within 6 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CIN regression rate after treatment with TCA 85%</measure>
    <time_frame>6 months</time_frame>
    <description>measured by histologic regression within 6 (improvement of at least one clinical CIN grade) months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain scores</measure>
    <time_frame>6 months</time_frame>
    <description>measured by Visual Analogue Scale of a single use of TCA 85% in patients with CIN 1/2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type specific human papillomavirus clearance rate after treatment with TCA 85%</measure>
    <time_frame>6 months</time_frame>
    <description>human papillomavirus clearance rate after treatment with TCA 85% with CIN I/CIN // within 6 months</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Cervical Intraepithelial Neoplasia Grade 1</condition>
  <condition>Cervical Intraepithelial Neoplasia Grade 2</condition>
  <arm_group>
    <arm_group_label>TRICIN</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>If a patient is eligible&#xD;
local anesthesia with Xylocain 10% with a pump spray for a period of 10 seconds- one time application&#xD;
Procain 2%: local anesthesia with a swab for a period of 10 seconds- one time application&#xD;
Trichloroacetic acid TCA 85% 1-2 ml with soaked swab for max. 2 minutes -one time application</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Trichloroacetic acid 85% (TCA)</intervention_name>
    <description>Purpose and scope of Medical Device: Treatment and relief of a disease. Application to cervical intraepithelial neoplasia with a cotton swab.TCA is an investigational device intended to achieve a complete histologic remission in individuals with cervical intraepithelial neoplasia (CIN) grade 1/2.</description>
    <arm_group_label>TRICIN</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven CIN 1/2&#xD;
&#xD;
          -  adequate colposcopy (i.e. fully visible transformation zone and margins of any visible&#xD;
             lesion)&#xD;
&#xD;
          -  positive HPV test&#xD;
&#xD;
          -  conducted negative pregnancy test&#xD;
&#xD;
          -  women aged 18 to 50 years&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria are a cytologically suspected CIN (Pap IIID, IV)&#xD;
&#xD;
          -  inadequate colposcopy&#xD;
&#xD;
          -  negative or missing biopsy&#xD;
&#xD;
          -  cytology results indicating invasive disease (PAP V)&#xD;
&#xD;
          -  if the cervical lesion recedes into the endocervical canal&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  any medical circumstance considered relevant for proper performance of the study, or&#xD;
             risks to the patient, at the discretion of the investigator&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lukas Hefler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Krankenhaus Barmherzige Schwestern Linz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of gynaecology, Ordensklinikum Linz Ges.m.b.H, Barmherzige Schwestern</name>
      <address>
        <city>Linz</city>
        <zip>4010</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>March 17, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>March 29, 2022</last_update_submitted>
  <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2022</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>Neoplasms</mesh_term>
    <mesh_term>Carcinoma in Situ</mesh_term>
    <mesh_term>Uterine Cervical Dysplasia</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/NCT04400578
org study id: EKS 48/19
nct id: NCT04400578
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Trichloroacetic acid 85% =TCA is an investigational device intended to achieve a complete
      histologic remission in individuals with cervical intraepithelial neoplasia (CIN) grade 1/2.
      The device system is to be used only in accordance with the approved Investigational Plan on
      subjects, who have given written informed consent.

      High remission and regression rates are expected after a single topical treatment with 85%
      TCA. After a single topical treatment with 85% TCA for CIN 1-2 (Expected 70% or higher; null
      hypothesis: not higher than 55%). Regression is defined as improvement from high grade lesion
      (CIN 2) at baseline to low grade lesion (CIN 1) after TCA treatment. Regression from CIN 1
      normal squamous epithelium after the TCA treatment is equal to remission and will be counted
      as a remission in combined analysis. Remission is defined as complete histologic remission of
      CIN back to normal squamous epithelium after the TCA treatment, i.e., no cervical dysplasia
      is detectable by histology or cytology after the TCA treatment. Type-specific HPV Clearance
      is defined as disappearance of the HPV type detected at screening.
Visit and assessment Schedule:

      Visit1 Screening:

        -  Informed Consent,

        -  Inclusion/Exclusion Criteria,

        -  Medical History,

        -  Gynecological Examination

        -  Cytology

        -  HPV Test

        -  Colposcopy

        -  Biopsy

        -  VAS (Visual analog scale)

        -  Pregnancy test

      Visit 2 Treatment Day with TCA 85%:

        -  Colposcopy

        -  TCA Treatment

        -  VAS

        -  Pregnancy test

      Visit 3, Control 1, Week 10-14:

        -  Cytology

        -  HPV Test

        -  Colposcopy

        -  Biopsy

        -  4-quadrant biopsy

        -  ECC

        -  Adverse event monitoring If there is no sign of CIN during the colposcopic examination
           10-14 weeks a 4-quadrant biopsy and a ECC are performed

      Visit 4, Control 2, Week 22-26:

        -  Cytology

        -  HPV Test

        -  Colposcopy

        -  Biopsy

        -  4-quadrant biopsy

        -  ECC

        -  Adverse event monitoring

        -  Pregnancy test If there is no sign of CIN during the colposcopic examination 22-26 weeks
           after the TCA treatment, a 4-quadrant biopsy and a ECC are performed.

      Visit 5, EOS , Week 24-30:

      - Results Discussion
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: CIN remission rate after treatment with TCA 85%
time frame: 6 months
description: measured by histologic remission within 6 months
measure: CIN regression rate after treatment with TCA 85%
time frame: 6 months
description: measured by histologic regression within 6 (improvement of at least one clinical CIN grade) months
measure: Pain scores
time frame: 6 months
description: measured by Visual Analogue Scale of a single use of TCA 85% in patients with CIN 1/2
measure: Type specific human papillomavirus clearance rate after treatment with TCA 85%
time frame: 6 months
description: human papillomavirus clearance rate after treatment with TCA 85% with CIN I/CIN // within 6 months
arm group label: TRICIN
arm group type: Experimental
description: If a patient is eligible
local anesthesia with Xylocain 10% with a pump spray for a period of 10 seconds- one time application
Procain 2%: local anesthesia with a swab for a period of 10 seconds- one time application
Trichloroacetic acid TCA 85% 1-2 ml with soaked swab for max. 2 minutes -one time application
intervention type: Device
intervention name: Trichloroacetic acid 85% (TCA)
description: Purpose and scope of Medical Device: Treatment and relief of a disease. Application to cervical intraepithelial neoplasia with a cotton swab.TCA is an investigational device intended to achieve a complete histologic remission in individuals with cervical intraepithelial neoplasia (CIN) grade 1/2.
arm group label: TRICIN
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Lukas Hefler, MD
role: Principal Investigator
affiliation: Krankenhaus Barmherzige Schwestern Linz
facility: 
country: Austria
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Carcinoma in Situ
mesh term: Uterine Cervical Dysplasia