<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/NCT04461574</url>
  </required_header>
  <id_info>
    <org_study_id>147-06</org_study_id>
    <nct_id>NCT04461574</nct_id>
  </id_info>
  <brief_title>Orcellex® Brush Versus Cervex-Brush® on Vault Smear Adequacy in Patients Treated With Radiotherapy for Cervical Cancer</brief_title>
  <official_title>Clinical Trial Comparing the Use of Orcellex® Brush Versus Cervex-Brush® on Vaginal Vault Smear Cytology Adequacy Rate in Patients Treated With Radiotherapy for Cervical Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Princess Margaret Hospital, Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Princess Margaret Hospital, Hong Kong</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Vaginal vault cytology is commonly used for follow-up surveillance in patients treated for&#xD;
      cervical cancer. It is known that the smear inadequacy rate is high, especially in patients&#xD;
      post-radiotherapy at 10%. The current practice is to use Cervex-Brush®, which was designed&#xD;
      for cervical smear taking. Cervix will shrink into a dimple with a flat vaginal vault and&#xD;
      vagina may be stenotic after radiotherapy, rendering the use of the conventional sampling&#xD;
      device difficult. Orcellex® Brush was designed to collect cells from oral mucosa, with high&#xD;
      patient satisfaction and low smear inadequacy of 1% in one study. As both the vaginal vault&#xD;
      mucosa and oral mucosa are flat surface lined with stratified squamous epithelium, the use of&#xD;
      Orcellex® Brush in vaginal vault smear appeared applicable. It has a smaller head with a flat&#xD;
      surface of hair, which might better fit the flat vault surface and narrow vaginal canal. It&#xD;
      is postulated that the Orcellex® Brush helps in improving vaginal vault smear adequacy rate&#xD;
      in patients after radiotherapy treatment for cervical cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with cervical cancer treated with primary irradiation will be recruited at their&#xD;
      routine post-treatment surveillance follow-up in the out-patient clinic, in the order of&#xD;
      their appointment time. Study procedure will be explained and written informed consent is&#xD;
      obtained from each subject at the visit. Systemic and vaginal examination will be carried out&#xD;
      as usual. Subjects will receive vaginal vault smear by both Cervex-Brush® and Orcellex® Brush&#xD;
      during the same speculum examination. The order of using smear sampling devices will be&#xD;
      randomized. Randomization will be carried out according to computer-generated random numbers,&#xD;
      allocated by sequentially numbered, sealed opaque envelopes. Subjects will be randomized into&#xD;
      two groups: using Cervex-Brush® first followed by Orcellex® Brush, or vice versa. The&#xD;
      procedure of smear taking will be carried out by four trained clinicians who are independent&#xD;
      of the study. The method of smear taking will be standardized for both Cervex-Brush® and&#xD;
      Orcellex® Brush. The vaginal vault will be swept horizontally by the brush and the cervical&#xD;
      dimple, if seen, will be rotated five times by the brush. Each sampling device will be shaken&#xD;
      vigorously in separate Thinprep specimen containers, which is labelled as smear A for&#xD;
      Cervex-Brush® and smear B for Orcellex® Brush.&#xD;
&#xD;
      The subjects are unaware of the sequence of the sampling device used, as they cannot see the&#xD;
      procedure of smear taking during examination. The patient will be asked about the pain score&#xD;
      during each smear taking, by using the visual analog scale. Any vaginal bleeding will be&#xD;
      recorded.&#xD;
&#xD;
      The specimen will be sent to the laboratory and will be processed by the ThinPrep method. The&#xD;
      cytopathologist is unaware as to which device is used for that particular specimen and the&#xD;
      slide prepared from it. One pathologist will be responsible in screening all the vault smears&#xD;
      involved in this study. Adequacy of vault smear sample was defined by the Bethesda System as&#xD;
      a minimum of 2000 well-visualized and well-preserved squamous cells.&#xD;
&#xD;
      Patients will be arranged subsequent follow-up visits at appropriate time interval according&#xD;
      to the department protocol. Patients with inadequate smear result by both sampling devices&#xD;
      will be called back early within 8 weeks for repeat smear using the conventional&#xD;
      Cervex-Brush®.&#xD;
&#xD;
      Patients with cervical cancer in the department will have surveillance follow-ups at variable&#xD;
      intervals from 3 months to 12 months, depending on the time interval from previous treatment&#xD;
      and patients' symptoms. Some patients may have repeated smears during the study period. As&#xD;
      the result of previous smear will have no impact on the adequacy rate of subsequent smear,&#xD;
      patients can be recruited for smear taking more than once in the study. Hence the actual&#xD;
      number of patients recruited in the study would be less than the calculated sample size of&#xD;
      160.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vault cytology adequacy rate</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Adequacy of vault smear sample was defined by the Bethesda System as a minimum of 2000 well-visualized and well-preserved squamous cells</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient pain score</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Pain score 0-10 by visual analog scale higher score means higher level of pain minimum = 0 maximum = 10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vaginal bleeding</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Any bleeding noted by investigators during per vaginal examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Detection of abnormal cytology</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Any detection of abnormal cells by vault cytology</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>borderline cellularity rate</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>borderline cellularity requiring further clarification</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>Cervex Brush</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Orcellex Brush</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Orcellex Brush</intervention_name>
    <description>Subjects will receive vaginal vault smear using both Orcellex Brush and Cervex Brush at the same follow-up visit, with order of smear taking decided by randomization.</description>
    <arm_group_label>Cervex Brush</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cervex Brush</intervention_name>
    <description>Subjects will receive vaginal vault smear using both Orcellex Brush and Cervex Brush at the same follow-up visit, with order of smear taking decided by randomization.</description>
    <arm_group_label>Orcellex Brush</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with cervical cancer treated with primary radiotherapy&#xD;
&#xD;
          -  Patients aged 18 years or older&#xD;
&#xD;
          -  Patients requiring vaginal vault cytology for follow-up surveillance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who refuse vaginal examination or vaginal vault smear at follow-up.&#xD;
&#xD;
          -  Patients who have visible tumour at vaginal vault requiring direct biopsy at speculum&#xD;
             examination.&#xD;
&#xD;
          -  Patients who cannot understand the study purpose and procedure.&#xD;
&#xD;
          -  Patients who cannot read the words written in Chinese or English.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mung Yuen He, MBBS</last_name>
    <phone>85262403147</phone>
    <email>hmy703@ha.org.hk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Princess Margaret Hospital</name>
      <address>
        <city>Hong Kong</city>
        <zip>000</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mung Yuen He, MBBS</last_name>
      <phone>85262403147</phone>
      <email>hmy703@ha.org.hk</email>
    </contact>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>March 15, 2021</last_update_submitted>
  <last_update_submitted_qc>March 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Princess Margaret Hospital, Hong Kong</investigator_affiliation>
    <investigator_full_name>He Mung Yuen</investigator_full_name>
    <investigator_title>Associate Consultant</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</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/NCT04461574
org study id: 147-06
nct id: NCT04461574
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Vaginal vault cytology is commonly used for follow-up surveillance in patients treated for
      cervical cancer. It is known that the smear inadequacy rate is high, especially in patients
      post-radiotherapy at 10%. The current practice is to use Cervex-Brush®, which was designed
      for cervical smear taking. Cervix will shrink into a dimple with a flat vaginal vault and
      vagina may be stenotic after radiotherapy, rendering the use of the conventional sampling
      device difficult. Orcellex® Brush was designed to collect cells from oral mucosa, with high
      patient satisfaction and low smear inadequacy of 1% in one study. As both the vaginal vault
      mucosa and oral mucosa are flat surface lined with stratified squamous epithelium, the use of
      Orcellex® Brush in vaginal vault smear appeared applicable. It has a smaller head with a flat
      surface of hair, which might better fit the flat vault surface and narrow vaginal canal. It
      is postulated that the Orcellex® Brush helps in improving vaginal vault smear adequacy rate
      in patients after radiotherapy treatment for cervical cancer.
Patients with cervical cancer treated with primary irradiation will be recruited at their
      routine post-treatment surveillance follow-up in the out-patient clinic, in the order of
      their appointment time. Study procedure will be explained and written informed consent is
      obtained from each subject at the visit. Systemic and vaginal examination will be carried out
      as usual. Subjects will receive vaginal vault smear by both Cervex-Brush® and Orcellex® Brush
      during the same speculum examination. The order of using smear sampling devices will be
      randomized. Randomization will be carried out according to computer-generated random numbers,
      allocated by sequentially numbered, sealed opaque envelopes. Subjects will be randomized into
      two groups: using Cervex-Brush® first followed by Orcellex® Brush, or vice versa. The
      procedure of smear taking will be carried out by four trained clinicians who are independent
      of the study. The method of smear taking will be standardized for both Cervex-Brush® and
      Orcellex® Brush. The vaginal vault will be swept horizontally by the brush and the cervical
      dimple, if seen, will be rotated five times by the brush. Each sampling device will be shaken
      vigorously in separate Thinprep specimen containers, which is labelled as smear A for
      Cervex-Brush® and smear B for Orcellex® Brush.

      The subjects are unaware of the sequence of the sampling device used, as they cannot see the
      procedure of smear taking during examination. The patient will be asked about the pain score
      during each smear taking, by using the visual analog scale. Any vaginal bleeding will be
      recorded.

      The specimen will be sent to the laboratory and will be processed by the ThinPrep method. The
      cytopathologist is unaware as to which device is used for that particular specimen and the
      slide prepared from it. One pathologist will be responsible in screening all the vault smears
      involved in this study. Adequacy of vault smear sample was defined by the Bethesda System as
      a minimum of 2000 well-visualized and well-preserved squamous cells.

      Patients will be arranged subsequent follow-up visits at appropriate time interval according
      to the department protocol. Patients with inadequate smear result by both sampling devices
      will be called back early within 8 weeks for repeat smear using the conventional
      Cervex-Brush®.

      Patients with cervical cancer in the department will have surveillance follow-ups at variable
      intervals from 3 months to 12 months, depending on the time interval from previous treatment
      and patients' symptoms. Some patients may have repeated smears during the study period. As
      the result of previous smear will have no impact on the adequacy rate of subsequent smear,
      patients can be recruited for smear taking more than once in the study. Hence the actual
      number of patients recruited in the study would be less than the calculated sample size of
      160.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: Vault cytology adequacy rate
time frame: through study completion, an average of 1 year
description: Adequacy of vault smear sample was defined by the Bethesda System as a minimum of 2000 well-visualized and well-preserved squamous cells
measure: Patient pain score
time frame: through study completion, an average of 1 year
description: Pain score 0-10 by visual analog scale higher score means higher level of pain minimum = 0 maximum = 10
measure: Vaginal bleeding
time frame: through study completion, an average of 1 year
description: Any bleeding noted by investigators during per vaginal examination
measure: Detection of abnormal cytology
time frame: through study completion, an average of 1 year
description: Any detection of abnormal cells by vault cytology
measure: borderline cellularity rate
time frame: through study completion, an average of 1 year
description: borderline cellularity requiring further clarification
arm group label: Cervex Brush
arm group type: Placebo Comparator
arm group label: Orcellex Brush
arm group type: Active Comparator
intervention type: Device
intervention name: Orcellex Brush
description: Subjects will receive vaginal vault smear using both Orcellex Brush and Cervex Brush at the same follow-up visit, with order of smear taking decided by randomization.
arm group label: Cervex Brush
intervention type: Device
intervention name: Cervex Brush
description: Subjects will receive vaginal vault smear using both Orcellex Brush and Cervex Brush at the same follow-up visit, with order of smear taking decided by randomization.
arm group label: Orcellex Brush
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mung Yuen He, MBBS
phone: 85262403147
email: hmy703@ha.org.hk
facility: 
status: Recruiting
contact: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Princess Margaret Hospital, Hong Kong
investigator full name: He Mung Yuen
investigator title: Associate Consultant
mesh term: Uterine Cervical Neoplasms