<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/NCT03241680</url>
  </required_header>
  <id_info>
    <org_study_id>Citologia anal</org_study_id>
    <nct_id>NCT03241680</nct_id>
  </id_info>
  <brief_title>Study of Anal Cytologies in Patients With High Grade Cervical Intraepithelial Neoplasia (CIN II and III)</brief_title>
  <official_title>Study of Anal Cytologies in Patients With High Grade Cervical Intraepithelial Neoplasia (CIN II and III)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade do Vale do Sapucai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade do Vale do Sapucai</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>
      Cervical cancer is the third most frequent neoplasm in Brazilian women (estimated risk of&#xD;
      15.33 cases / 100,000 women by 2014), behind breast and colorectal cancer.&#xD;
&#xD;
      This high incidence is explained by the pre-neoplastic lesions of the cervix being probably&#xD;
      related to the practice of unsafe sex and to a poor local immune response against HPV.&#xD;
&#xD;
      Human papillomavirus (HPV) infection affects people of any age, although it is more common in&#xD;
      young people, probably due to increased sexual activity in that period.&#xD;
&#xD;
      The association between high-risk HPV and anus neoplasm in men and women with&#xD;
      immunodeficiency or immunosuppression has been confirmed and measures related to surveillance&#xD;
      are standardized.&#xD;
&#xD;
      In patients without immunodeficiencies, this association is still unclear, which may&#xD;
      contribute to the lack of adequate standards to diagnose HPV and prevent cancer of the anus.&#xD;
&#xD;
      The frequency of the cancer of anus previously considered low, is currently in considerable&#xD;
      elevation, mainly squamous cell carcinoma (SCC).&#xD;
&#xD;
      The causal relationship between this virus and cancer of the cervix and the anus is&#xD;
      established. These facts have motivated the inclusion of this disease as STD, which justifies&#xD;
      the necessity of adopting surveillance measures in the clinics of sexual, gynecological and&#xD;
      urological diseases.&#xD;
&#xD;
      Cancer of the anus, when diagnosed in the early stage, makes healing possible with less&#xD;
      aggressive treatments, but in the advanced stage, abdominoperineal amputation is necessary.&#xD;
&#xD;
      Concerned about possible anal cancer, some gynecologists have referred patients with genital&#xD;
      HPV to search for anal infection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 2, 2017</start_date>
  <completion_date type="Anticipated">May 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Study of Anal Cytologies in Patients With High Grade Cervical Intraepithelial Neoplasia (CIN II and III)</measure>
    <time_frame>Six months</time_frame>
    <description>Search for alterations in the anal cytology of patients with CIN 2-3 in conventional and liquid based anal citology</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Anal Carcinoma</condition>
  <condition>Anal Condyloma</condition>
  <arm_group>
    <arm_group_label>Control Group with conventional citology</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients who do not have high grade cervical intraepithelial neoplasia and will have anal cytology performed by conventional method</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group with liquid based citology</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients who do not have cervical intraepithelial neoplasia of high grade and will have anal cytology performed by liquid based method</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CIN 2-3/Conventional Citology</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients with high grade cervical intraepithelial neoplasia and will have anal citology performed by conventional method</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CIN 2-3/Liquid Based</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with high grade cervical intraepithelial neoplasia and will have anal citology performed by liquid based method</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Search of anal citology alterations</intervention_name>
    <description>All patients with a pathological diagnosis of CIN II and III, and in the general gynecological surgery outpatient clinic, will be selected at the outpatient clinic of Oncology Gynecology of the HCSL for a period of six months.&#xD;
Patients who meet the eligibility criteria will be clarified about the study, and only those who agree to participate will be included, by signing the informed consent form (TCLE).</description>
    <arm_group_label>CIN 2-3/Liquid Based</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Female patients aged 18-65 years with an anatomic pathology compatible with CIN II / CIN&#xD;
        III, without restriction regarding skin color, race, ethnicity, religion; Patients of the&#xD;
        Oncology Gynecology Service of the HCSL, registered in the hospital management system, in&#xD;
        outpatient consultations; Those who agree to participate in the study and sign the ICF.&#xD;
        Patients attended at the general gynecological surgery outpatient clinic (control group)&#xD;
        with no evidence of colpocitological alteration.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients who withdraw the consent term. History of previous anal cancer / anal&#xD;
        intraepithelial neoplasia. Immunosuppressed: HIV, SLE, users of immunosuppressive and&#xD;
        transplanted drugs.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniela F Veiga</last_name>
    <role>Study Chair</role>
    <affiliation>Vale do Sapucai University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>LYLIANA C R BARBOSA</last_name>
    <phone>35988532927</phone>
    <email>magibarbosa@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Lyliana C R Barbosa</name>
      <address>
        <city>Pouso Alegre</city>
        <state>MG</state>
        <zip>37550000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>LYLIANA C R BARBOSA</last_name>
      <phone>35988532927</phone>
      <email>magibarbosa@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>MARCIO E FRANCO RIBEIRO</last_name>
      <email>marcioerikfr@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>August 2, 2017</last_update_submitted>
  <last_update_submitted_qc>August 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade do Vale do Sapucai</investigator_affiliation>
    <investigator_full_name>Lyliana Coutinho Resende Barbosa</investigator_full_name>
    <investigator_title>MD Phd</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Dysplasia</mesh_term>
    <mesh_term>Anus Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03241680
org study id: Citologia anal
nct id: NCT03241680
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Cervical cancer is the third most frequent neoplasm in Brazilian women (estimated risk of
      15.33 cases / 100,000 women by 2014), behind breast and colorectal cancer.

      This high incidence is explained by the pre-neoplastic lesions of the cervix being probably
      related to the practice of unsafe sex and to a poor local immune response against HPV.

      Human papillomavirus (HPV) infection affects people of any age, although it is more common in
      young people, probably due to increased sexual activity in that period.

      The association between high-risk HPV and anus neoplasm in men and women with
      immunodeficiency or immunosuppression has been confirmed and measures related to surveillance
      are standardized.

      In patients without immunodeficiencies, this association is still unclear, which may
      contribute to the lack of adequate standards to diagnose HPV and prevent cancer of the anus.

      The frequency of the cancer of anus previously considered low, is currently in considerable
      elevation, mainly squamous cell carcinoma (SCC).

      The causal relationship between this virus and cancer of the cervix and the anus is
      established. These facts have motivated the inclusion of this disease as STD, which justifies
      the necessity of adopting surveillance measures in the clinics of sexual, gynecological and
      urological diseases.

      Cancer of the anus, when diagnosed in the early stage, makes healing possible with less
      aggressive treatments, but in the advanced stage, abdominoperineal amputation is necessary.

      Concerned about possible anal cancer, some gynecologists have referred patients with genital
      HPV to search for anal infection.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Study of Anal Cytologies in Patients With High Grade Cervical Intraepithelial Neoplasia (CIN II and III)
time frame: Six months
description: Search for alterations in the anal cytology of patients with CIN 2-3 in conventional and liquid based anal citology
arm group label: Control Group with conventional citology
arm group type: No Intervention
description: Patients who do not have high grade cervical intraepithelial neoplasia and will have anal cytology performed by conventional method
arm group label: Control Group with liquid based citology
arm group type: No Intervention
description: Patients who do not have cervical intraepithelial neoplasia of high grade and will have anal cytology performed by liquid based method
arm group label: CIN 2-3/Conventional Citology
arm group type: No Intervention
description: Patients with high grade cervical intraepithelial neoplasia and will have anal citology performed by conventional method
arm group label: CIN 2-3/Liquid Based
arm group type: Active Comparator
description: Patients with high grade cervical intraepithelial neoplasia and will have anal citology performed by liquid based method
intervention type: Diagnostic Test
intervention name: Search of anal citology alterations
description: All patients with a pathological diagnosis of CIN II and III, and in the general gynecological surgery outpatient clinic, will be selected at the outpatient clinic of Oncology Gynecology of the HCSL for a period of six months.
Patients who meet the eligibility criteria will be clarified about the study, and only those who agree to participate will be included, by signing the informed consent form (TCLE).
arm group label: CIN 2-3/Liquid Based
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Daniela F Veiga
role: Study Chair
affiliation: Vale do Sapucai University
last name: LYLIANA C R BARBOSA
phone: 35988532927
email: magibarbosa@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade do Vale do Sapucai
investigator full name: Lyliana Coutinho Resende Barbosa
investigator title: MD Phd
mesh term: Uterine Cervical Dysplasia
mesh term: Anus Neoplasms
sharing ipd: No