<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/NCT03757299</url>
  </required_header>
  <id_info>
    <org_study_id>2017-01110</org_study_id>
    <nct_id>NCT03757299</nct_id>
  </id_info>
  <brief_title>Promoting Comprehensive Cervical Cancer Prevention and Better Women Health in Cameroon</brief_title>
  <acronym>PCCCP</acronym>
  <official_title>Promoting Comprehensive Cervical Cancer Prevention and Better Women Health in Cameroon</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof. Patrick Petignat</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Geneva</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>
      In sub-Saharan Africa, cervical cancer is the leading cause of cancer death among women&#xD;
      because of the difficulty in implementing screening programs. The main obstacles in these&#xD;
      countries are poverty, lack of healthcare infrastructures and trained practitioners. With the&#xD;
      availability of new technologies, researchers are looking for new strategies adapted to low-&#xD;
      and middle-income countries to identify cervical precancerous lesions.&#xD;
&#xD;
      Current evidence shows that Human Papilloma Virus (HPV) testing is more effective than&#xD;
      cytology (Pap smear) for cervical cancer screening in resource-limited settings. Indeed, the&#xD;
      GeneXpert® HPV test offers the opportunity to prevent cervical cancer (CC) in a single visit:&#xD;
      rapid detection of high-risk HPV (HPV) infection followed by same day treatment of&#xD;
      HPV-positive women during the same visit (screen-and-treat approach).&#xD;
&#xD;
      However only a small proportion of HPV-positive women will develop cervical (pre)cancer,&#xD;
      making it important to select those to treat. This triage can be achieved by colposcopy,&#xD;
      cytology and visual inspection after application of acetic acid (VIA). Though VIA is the&#xD;
      triage test recommended by WHO for resource-limited countries, it has not yet been widely&#xD;
      assessed in sub-Saharan Africa (SSA).&#xD;
&#xD;
      The main objective of the investigators is to assess the performance of HPV-test followed by&#xD;
      Visual Inspection after application of Acetic acid and Lugol's iodine VIA/VILI to detect&#xD;
      cervical precancerous lesions in a screen-and-treat strategy in Cameroon (sub-Saharan Africa)&#xD;
      where there is no cervical cancer-screening program.&#xD;
&#xD;
      The investigators organized a successful free screening campaign in Cameroon in 2015 that&#xD;
      allowed to identify the expectations of women and their eagerness to benefit from prevention&#xD;
      of gynecological cancers and sexually transmitted diseases.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">October 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2023</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity and specificity of HPV test followed by VIA/VILI to detect cervical precancerous lesions in sub-Saharan Africa using histology as gold standard</measure>
    <time_frame>3 - 5 years</time_frame>
    <description>VIA/VILI is assessed by pelvic examination and Sensitivity and specificity are measured by using histology as gold stantard</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of HPV infection</measure>
    <time_frame>3 - 5 years</time_frame>
    <description>HPV self-test analysed by GeneXpert machine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of cervical pre-cancer and cancer among Cameroonian women</measure>
    <time_frame>3 - 5 years</time_frame>
    <description>Histological analyses of cervical biopsies and endocervical brushing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HPV clearance</measure>
    <time_frame>3 - 5 years</time_frame>
    <description>Measured by self HPV performed at 6 and 12 months follow up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Persistance of CIN2+ disease at the 12-month follow-up</measure>
    <time_frame>3 - 5 years</time_frame>
    <description>Histological analyses of cervical biopsies and endocervical brushing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Provide teaching material for professional training on cervical cancer prevention through VIA/VILI (cervical images database)</measure>
    <time_frame>3 - 5 years</time_frame>
    <description>images database</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability rate of self-HPV test and cervical cancer screening procedures</measure>
    <time_frame>3 years</time_frame>
    <description>To assess the acceptability of self-HPV, patients complete a questionnaire comprising different questions about the collection device (embarassment, comfort, anxiety and confidence about the test).&#xD;
Likert Scale 4 points : 1 (not at all) to 4 (very).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of side effects and complications after thermoablation or LEEP</measure>
    <time_frame>3 - 5 years</time_frame>
    <description>questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VIA test-positive rate (HPV-positive women);</measure>
    <time_frame>3 - 5 years</time_frame>
    <description>VIA/VILI is assessed by pelvic examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VIA test-positive rate after 1- year follow-up of VIA-negative tests</measure>
    <time_frame>3 - 5 years</time_frame>
    <description>VIA/VILI is assessed by pelvic examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thermal ablation efficacy rate</measure>
    <time_frame>3 - 5 years</time_frame>
    <description>Thermal ablation efficacy rate will be assessed according to the biopsy proven CIN2+ rate after thermoablation treatment at the 6 and 12-month follow-up. The absence of CIN2+ will determine the success of the treatment in a patient who previously had a CIN2+ lesion.&#xD;
Adverses event : bleeding, complications, hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability rate of thermoablation</measure>
    <time_frame>3 years</time_frame>
    <description>To assess the acceptability of thermoablation, patients completed a questionnaire comprising different questions about treatment tolerance, pain and following side effects. Respondent were invited to rate answers on a likert scale of 1 (no accpetability) to 4 (high acceptability)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual dysfunction score, score of anxiety and method of contraception after screening procedures,</measure>
    <time_frame>2 years</time_frame>
    <description>SF12, Asex, STAI 6 Y-form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of women screened with and without community health care workers.</measure>
    <time_frame>2 years</time_frame>
    <description>community health workers registre</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Increase awareness on gynecological pathologies, including cervical cancer, sexually transmitted diseases and HIV, vaginal fistula in the community of the study area,</measure>
    <time_frame>3-5 years</time_frame>
    <description>questionnaire</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">6000</enrollment>
  <condition>Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>Self HPV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>HPV Test</intervention_name>
    <description>Vaginal specimens for HPV test will be collected by participants themselves using flocked swabs after explanations by co-investigators. Two transport mediums will be used for those self-collected vaginal samples: NaCl 0.9%.</description>
    <arm_group_label>Self HPV</arm_group_label>
    <other_name>VIA/VILI,</other_name>
    <other_name>Pap smear,</other_name>
    <other_name>Cervical biopsy</other_name>
    <other_name>ECC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged 30-49 years, able to comply with the study protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Previous total hysterectomy&#xD;
&#xD;
          -  Conditions impairing examination of the cervix&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Only women will be recruited by the study</gender_description>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Geneva</name>
      <address>
        <city>Geneva</city>
        <zip>1205</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick Petignat</last_name>
      <phone>+4122 37 24 432</phone>
      <email>patrick.petignat@hcuge.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>May 9, 2023</last_update_submitted>
  <last_update_submitted_qc>May 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
    <investigator_full_name>Prof. Patrick Petignat</investigator_full_name>
    <investigator_title>Director of the gynecology departement</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>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03757299
org study id: 2017-01110
nct id: NCT03757299
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In sub-Saharan Africa, cervical cancer is the leading cause of cancer death among women
      because of the difficulty in implementing screening programs. The main obstacles in these
      countries are poverty, lack of healthcare infrastructures and trained practitioners. With the
      availability of new technologies, researchers are looking for new strategies adapted to low-
      and middle-income countries to identify cervical precancerous lesions.

      Current evidence shows that Human Papilloma Virus (HPV) testing is more effective than
      cytology (Pap smear) for cervical cancer screening in resource-limited settings. Indeed, the
      GeneXpert® HPV test offers the opportunity to prevent cervical cancer (CC) in a single visit:
      rapid detection of high-risk HPV (HPV) infection followed by same day treatment of
      HPV-positive women during the same visit (screen-and-treat approach).

      However only a small proportion of HPV-positive women will develop cervical (pre)cancer,
      making it important to select those to treat. This triage can be achieved by colposcopy,
      cytology and visual inspection after application of acetic acid (VIA). Though VIA is the
      triage test recommended by WHO for resource-limited countries, it has not yet been widely
      assessed in sub-Saharan Africa (SSA).

      The main objective of the investigators is to assess the performance of HPV-test followed by
      Visual Inspection after application of Acetic acid and Lugol's iodine VIA/VILI to detect
      cervical precancerous lesions in a screen-and-treat strategy in Cameroon (sub-Saharan Africa)
      where there is no cervical cancer-screening program.

      The investigators organized a successful free screening campaign in Cameroon in 2015 that
      allowed to identify the expectations of women and their eagerness to benefit from prevention
      of gynecological cancers and sexually transmitted diseases.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Sensitivity and specificity of HPV test followed by VIA/VILI to detect cervical precancerous lesions in sub-Saharan Africa using histology as gold standard
time frame: 3 - 5 years
description: VIA/VILI is assessed by pelvic examination and Sensitivity and specificity are measured by using histology as gold stantard
measure: Prevalence of HPV infection
time frame: 3 - 5 years
description: HPV self-test analysed by GeneXpert machine
measure: Prevalence of cervical pre-cancer and cancer among Cameroonian women
time frame: 3 - 5 years
description: Histological analyses of cervical biopsies and endocervical brushing
measure: HPV clearance
time frame: 3 - 5 years
description: Measured by self HPV performed at 6 and 12 months follow up
measure: Persistance of CIN2+ disease at the 12-month follow-up
time frame: 3 - 5 years
description: Histological analyses of cervical biopsies and endocervical brushing
measure: Provide teaching material for professional training on cervical cancer prevention through VIA/VILI (cervical images database)
time frame: 3 - 5 years
description: images database
measure: Acceptability rate of self-HPV test and cervical cancer screening procedures
time frame: 3 years
description: To assess the acceptability of self-HPV, patients complete a questionnaire comprising different questions about the collection device (embarassment, comfort, anxiety and confidence about the test).
Likert Scale 4 points : 1 (not at all) to 4 (very).
measure: Proportion of side effects and complications after thermoablation or LEEP
time frame: 3 - 5 years
description: questionnaire
measure: VIA test-positive rate (HPV-positive women);
time frame: 3 - 5 years
description: VIA/VILI is assessed by pelvic examination
measure: VIA test-positive rate after 1- year follow-up of VIA-negative tests
time frame: 3 - 5 years
description: VIA/VILI is assessed by pelvic examination
measure: Thermal ablation efficacy rate
time frame: 3 - 5 years
description: Thermal ablation efficacy rate will be assessed according to the biopsy proven CIN2+ rate after thermoablation treatment at the 6 and 12-month follow-up. The absence of CIN2+ will determine the success of the treatment in a patient who previously had a CIN2+ lesion.
Adverses event : bleeding, complications, hospitalization
measure: Acceptability rate of thermoablation
time frame: 3 years
description: To assess the acceptability of thermoablation, patients completed a questionnaire comprising different questions about treatment tolerance, pain and following side effects. Respondent were invited to rate answers on a likert scale of 1 (no accpetability) to 4 (high acceptability)
measure: Sexual dysfunction score, score of anxiety and method of contraception after screening procedures,
time frame: 2 years
description: SF12, Asex, STAI 6 Y-form
measure: Number of women screened with and without community health care workers.
time frame: 2 years
description: community health workers registre
measure: Increase awareness on gynecological pathologies, including cervical cancer, sexually transmitted diseases and HIV, vaginal fistula in the community of the study area,
time frame: 3-5 years
description: questionnaire
arm group label: Self HPV
arm group type: Experimental
intervention type: Diagnostic Test
intervention name: HPV Test
description: Vaginal specimens for HPV test will be collected by participants themselves using flocked swabs after explanations by co-investigators. Two transport mediums will be used for those self-collected vaginal samples: NaCl 0.9%.
arm group label: Self HPV
other name: VIA/VILI,
other name: Pap smear,
other name: Cervical biopsy
other name: ECC
criteria: 
gender: Female
gender based: Yes
gender description: Only women will be recruited by the study
minimum age: 30 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: University Hospital, Geneva
investigator full name: Prof. Patrick Petignat
investigator title: Director of the gynecology departement
mesh term: Uterine Cervical Neoplasms
sharing ipd: Undecided