<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/NCT02976987</url>
  </required_header>
  <id_info>
    <org_study_id>CHUB-POST-Colvir II</org_study_id>
    <nct_id>NCT02976987</nct_id>
  </id_info>
  <brief_title>A Prolongation of a Clinical Study to Evaluate the Efficacy of an Aqueous Gel Containing 2% (w/w) of Cidofovir, Directly Applied on the Cervix Exhibiting High Grade Squamous Intraepithelial Lesions.</brief_title>
  <official_title>A Prolongation of Phase II Clinical Study to Evaluate the Efficacy of an Aqueous Gel Containing 2% (w/w) of Cidofovir, Directly Applied on the Cervix Exhibiting High Grade Squamous Intraepithelial Lesions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brugmann University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brugmann University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The infections of high grade induced by the human papilloma viruses cause precancerous&#xD;
      lesions of the cervical epithelium. The progression of these lesions can lead to the onset of&#xD;
      cervical cancer. To reduce the risk of cancer lesions classified as 'cervical squamous&#xD;
      intraepithelial neoplasia 2' (CIN2) and 'cervical squamous intraepithelial neoplasia 3'&#xD;
      (CIN3), the standard treatment is the conisation of the cervix. This surgery can lead to&#xD;
      complications such as infertility or a risk of preterm birth, hence the need to move towards&#xD;
      a non-surgical alternative therapy.&#xD;
&#xD;
      The colvir clinical trial was a phase-II, multi center, randomized, double blind, efficacy&#xD;
      study of an aqueous gel containing 2% (w/w) cidofovir, administrated directly on cervix&#xD;
      exhibiting high grade squamous intraepithelial lesion (CIN 2 and 3).&#xD;
&#xD;
      This clinical trial is a prolongation of the colvir trial, in order to&#xD;
&#xD;
        -  assess the long term histological and virological evolution (24 months) of 3 g of 2%&#xD;
           (w/w) cidofovir gel, administrated directly on cervix exhibiting high grade&#xD;
           intraepithelial neoplasia after complete response, partial response or response failure&#xD;
           at the end of the Colvir study.&#xD;
&#xD;
        -  assess the long term (24 months) rate of recurrence of histological lesions of the&#xD;
           Colvir patients after conisation, in both placebo and treatment groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</primary_completion_date>
  <phase>Phase 2</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>change in biopsy conclusions (treatment success or not)</measure>
    <time_frame>24 months after initial treatment</time_frame>
    <description>A gynecological examination will be done, including colposcopy. Cervical sampling for virology will be taken and sent to Riatol laboratory. A biopsy will be taken in presence of colposcopic cervical squamous intraepithelial neoplasia (CIN2-3) lesions, or in case of colposcopic doubt lesions, or in case of persistence (after 6 months) of colposcopic CIN1 lesion or if the last cytology was a high grade squamous intraepithelial lesion (HSIL) cytology, or if the last cytology suspected glandular lesions, or if the two last cervical smears were low-grade intraepithelial lesion (LSIL) cytologies with presence of high risk human papillomavirus (HPV).The biopsy fixation, HE (eosin-hematoxylin) staining and P16 + Ki67 staining will be done according to a validated procedure. Biopsy slides will be send to the central lab for immunological and histological reading (three pathologic experts).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HPV viral load</measure>
    <time_frame>24 months after initial treatment</time_frame>
    <description>Cervical sampling for virology will be taken and send to Riatol laboratory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HPV genotype</measure>
    <time_frame>24 months after initial treatment</time_frame>
    <description>Cervical sampling for virology will be taken and send to Riatol laboratory.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>High Grade Cervical Epithelial Neoplasia (CIN2+)</condition>
  <arm_group>
    <arm_group_label>Cidofovir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women receiving an aqueous gel containing 2% (w/w) cidofovir, administrated directly on cervix exhibiting high grade squamous intraepithelial lesion (CIN 2 and 3).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cidofovir</intervention_name>
    <arm_group_label>Cidofovir</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women who participated in the COLVIR study and received complete treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women from the Colvir study who received incomplete treatment&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Catherine Vanpachterbeke, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Brugmann</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Brugmann Hospital</name>
      <address>
        <city>Brussels</city>
        <zip>1020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>November 25, 2016</last_update_submitted>
  <last_update_submitted_qc>November 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brugmann University Hospital</investigator_affiliation>
    <investigator_full_name>Catherine Vanpachterbeke</investigator_full_name>
    <investigator_title>Head of clinic</investigator_title>
  </responsible_party>
  <keyword>Colvir</keyword>
  <keyword>high grade squamous intraepithelial lesions</keyword>
  <keyword>cervix</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Squamous Intraepithelial Lesions of the Cervix</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Carcinoma in Situ</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cidofovir</mesh_term>
  </intervention_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/NCT02976987
org study id: CHUB-POST-Colvir II
nct id: NCT02976987
lead sponsor: 
has dmc: No
The infections of high grade induced by the human papilloma viruses cause precancerous
      lesions of the cervical epithelium. The progression of these lesions can lead to the onset of
      cervical cancer. To reduce the risk of cancer lesions classified as 'cervical squamous
      intraepithelial neoplasia 2' (CIN2) and 'cervical squamous intraepithelial neoplasia 3'
      (CIN3), the standard treatment is the conisation of the cervix. This surgery can lead to
      complications such as infertility or a risk of preterm birth, hence the need to move towards
      a non-surgical alternative therapy.

      The colvir clinical trial was a phase-II, multi center, randomized, double blind, efficacy
      study of an aqueous gel containing 2% (w/w) cidofovir, administrated directly on cervix
      exhibiting high grade squamous intraepithelial lesion (CIN 2 and 3).

      This clinical trial is a prolongation of the colvir trial, in order to

        -  assess the long term histological and virological evolution (24 months) of 3 g of 2%
           (w/w) cidofovir gel, administrated directly on cervix exhibiting high grade
           intraepithelial neoplasia after complete response, partial response or response failure
           at the end of the Colvir study.

        -  assess the long term (24 months) rate of recurrence of histological lesions of the
           Colvir patients after conisation, in both placebo and treatment groups.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: change in biopsy conclusions (treatment success or not)
time frame: 24 months after initial treatment
description: A gynecological examination will be done, including colposcopy. Cervical sampling for virology will be taken and sent to Riatol laboratory. A biopsy will be taken in presence of colposcopic cervical squamous intraepithelial neoplasia (CIN2-3) lesions, or in case of colposcopic doubt lesions, or in case of persistence (after 6 months) of colposcopic CIN1 lesion or if the last cytology was a high grade squamous intraepithelial lesion (HSIL) cytology, or if the last cytology suspected glandular lesions, or if the two last cervical smears were low-grade intraepithelial lesion (LSIL) cytologies with presence of high risk human papillomavirus (HPV).The biopsy fixation, HE (eosin-hematoxylin) staining and P16 + Ki67 staining will be done according to a validated procedure. Biopsy slides will be send to the central lab for immunological and histological reading (three pathologic experts).
measure: HPV viral load
time frame: 24 months after initial treatment
description: Cervical sampling for virology will be taken and send to Riatol laboratory.
measure: HPV genotype
time frame: 24 months after initial treatment
description: Cervical sampling for virology will be taken and send to Riatol laboratory.
arm group label: Cidofovir
arm group type: Experimental
description: Women receiving an aqueous gel containing 2% (w/w) cidofovir, administrated directly on cervix exhibiting high grade squamous intraepithelial lesion (CIN 2 and 3).
intervention type: Drug
intervention name: Cidofovir
arm group label: Cidofovir
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Catherine Vanpachterbeke, MD
role: Principal Investigator
affiliation: CHU Brugmann
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Brugmann University Hospital
investigator full name: Catherine Vanpachterbeke
investigator title: Head of clinic
mesh term: Squamous Intraepithelial Lesions of the Cervix
mesh term: Carcinoma, Squamous Cell
mesh term: Carcinoma in Situ
mesh term: Cidofovir