xml: <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/NCT05996796</url>
    </required_header>
    <id_info>
      <org_study_id>B3002023000038</org_study_id>
      <nct_id>NCT05996796</nct_id>
    </id_info>
    <brief_title>Dry Run of the ScreenUrSelf Trial</brief_title>
    <official_title>Cervical Cancer Screening Based on First-void Urine Self-sampling to Reach un(Der)-Screened Women: Dry Run of the ScreenUrSelf Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universiteit Antwerpen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Antwerp University Hospital (UZA)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Centre for Cancer Detection (CvKO)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Sciensano</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Universiteit Antwerpen</source>
    <oversight_info>
      <has_dmc>No</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>
        The proposed study is the Dry Run preceding the ScreenUrSelf trial.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The ScreenUrSelf trial will be embedded in the Flemish organized cervical cancer screening&#xD;
        program. The goal of ScreenUrSelf is to reach women who are eligible but do not participate&#xD;
        in cervical cancer screening, by offering two self-sampling methods (first-void urine and&#xD;
        vaginal) in an opt-in and -out strategy (total of four interventions) to collect samples for&#xD;
        primary high-risk (hr) Human Papillomavirus (HPV) testing, and if positive, reflex 1)&#xD;
        cytology on a Pap smear (standard of care) and 2) methylation marker triage (index test). The&#xD;
        two control arms include 1) no intervention; and 2) sending (recall) invitation letters to&#xD;
        women, inviting them to make an appointment for a Pap smear (i.e., current practice within&#xD;
        the organized cervical cancer screening program in Flanders).&#xD;
  &#xD;
        The Dry Run which is the subject of this clinical trial will test the study materials and&#xD;
        data flows developed for the interventional study arms (C, D, E and F) of the ScreenUrSelf&#xD;
        trial. The primary outcome of the Dry Run is to check if the flow for data- and sample&#xD;
        collection is ready for start of the ScreenUrSelf trial, and if optimizations are deemed&#xD;
        necessary before start of the trial.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 10, 2023</start_date>
    <completion_date type="Actual">June 15, 2023</completion_date>
    <primary_completion_date type="Actual">June 12, 2023</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>Parallel Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>HPV DNA using the Riatol qPCR HPV genotyping assay</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>HPV DNA concentration [copies/µl DNA] in self-samples from all study participants.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Human DNA (Beta-globin) using the Riatol qPCR HPV genotyping assay</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Human DNA concentration [copies/µl DNA] in self-samples from all study participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Preferences</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Preferences and attitudes of women regarding self-sampling (measured using a questionnaire)</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Actual">38</enrollment>
    <condition>Cervical Cancer</condition>
    <condition>Cervical Intraepithelial Neoplasia</condition>
    <condition>Human Papilloma Virus</condition>
    <condition>HPV-Related Cervical Carcinoma</condition>
    <arm_group>
      <arm_group_label>Opt-out first-void urine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Women will receive a first-void urine self-sampling study package at home.&#xD;
  The study package will include an invitation letter/informed consent form, information brochure, first-void urine self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Opt-in first-void urine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Women will receive a letter at home with instructions how to order (via phone, e-mail, or webform) a first-void urine self-sampling study package.&#xD;
  The study package will include an invitation letter/informed consent form, information brochure, first-void urine self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Opt-out vaginal self-sample</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Women will receive a vaginal self-sampling study package at home.&#xD;
  The study package will include an invitation letter/informed consent form, information brochure, vaginal self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Opt-in vaginal self-sample</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Women will receive a letter at home with instructions how to order (via phone, e-mail, or webform) a vaginal self-sampling study package.&#xD;
  The study package will include an invitation letter/informed consent form, information brochure, vaginal self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Colli-Pee Small Volumes</intervention_name>
      <description>Women will self-collect a first-void urine sample at home upon receipt of the study package using the Colli-Pee Small Volumes (10 mL) device (Novosanis, Belgium). The collector tube is prefilled with a preservative (UCM, Novosanis, Belgium). Women will send the collector vial containing first-void urine along with the informed consent form to the laboratory at University of Antwerp using the prestamped envelope.</description>
      <arm_group_label>Opt-in first-void urine</arm_group_label>
      <arm_group_label>Opt-out first-void urine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Evalyn Brush</intervention_name>
      <description>Women will self-collect a vaginal sample at home upon receipt of the study package using the Evalyn Brush device (Rovers Medical Devices, The Netherlands). Women will send the used brush along with the informed consent form to the laboratory at University of Antwerp using the prestamped envelope.</description>
      <arm_group_label>Opt-in vaginal self-sample</arm_group_label>
      <arm_group_label>Opt-out vaginal self-sample</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Eligible for cervical cancer screening within the organized Population-based Screening&#xD;
               Program in Flanders:&#xD;
  &#xD;
                 -  Female&#xD;
  &#xD;
                 -  Residing in Flanders, Belgium&#xD;
  &#xD;
                 -  No history of total hysterectomy&#xD;
  &#xD;
                 -  No (former) diagnosis of cervical or uterine cancer&#xD;
  &#xD;
                 -  30 - 64 years old (birth year 1959 - 1992)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Being pregnant or 6 weeks postpartum (self-reported after receiving the study&#xD;
               letter/package)&#xD;
  &#xD;
            -  Participation during menstruation or within the 3 following days is a contraindication&#xD;
  &#xD;
            -  Not able to understand the study materials and participation form (informed consent&#xD;
               form)&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>64 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Pierre Van Damme, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Universiteit Antwerpen</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Universiteit Antwerpen</name>
        <address>
          <city>Edegem</city>
          <state>Antwerp</state>
          <zip>2650</zip>
          <country>Belgium</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universiteit Antwerpen</investigator_affiliation>
      <investigator_full_name>Pierre Van Damme</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Biomarker</keyword>
    <keyword>First-void urine</keyword>
    <keyword>Vaginal sample</keyword>
    <keyword>Screening</keyword>
    <keyword>Triage</keyword>
    <keyword>Self-sampling</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Uterine Cervical Neoplasms</mesh_term>
      <mesh_term>Papilloma</mesh_term>
      <mesh_term>Uterine Cervical Dysplasia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05996796
  org study id: B3002023000038
  nct id: NCT05996796
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The proposed study is the Dry Run preceding the ScreenUrSelf trial.
  The ScreenUrSelf trial will be embedded in the Flemish organized cervical cancer screening
        program. The goal of ScreenUrSelf is to reach women who are eligible but do not participate
        in cervical cancer screening, by offering two self-sampling methods (first-void urine and
        vaginal) in an opt-in and -out strategy (total of four interventions) to collect samples for
        primary high-risk (hr) Human Papillomavirus (HPV) testing, and if positive, reflex 1)
        cytology on a Pap smear (standard of care) and 2) methylation marker triage (index test). The
        two control arms include 1) no intervention; and 2) sending (recall) invitation letters to
        women, inviting them to make an appointment for a Pap smear (i.e., current practice within
        the organized cervical cancer screening program in Flanders).
  
        The Dry Run which is the subject of this clinical trial will test the study materials and
        data flows developed for the interventional study arms (C, D, E and F) of the ScreenUrSelf
        trial. The primary outcome of the Dry Run is to check if the flow for data- and sample
        collection is ready for start of the ScreenUrSelf trial, and if optimizations are deemed
        necessary before start of the trial.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: HPV DNA using the Riatol qPCR HPV genotyping assay
  time frame: Through study completion, an average of 1 year
  description: HPV DNA concentration [copies/µl DNA] in self-samples from all study participants.
  measure: Human DNA (Beta-globin) using the Riatol qPCR HPV genotyping assay
  time frame: Through study completion, an average of 1 year
  description: Human DNA concentration [copies/µl DNA] in self-samples from all study participants
  measure: Preferences
  time frame: Through study completion, an average of 1 year
  description: Preferences and attitudes of women regarding self-sampling (measured using a questionnaire)
  arm group label: Opt-out first-void urine
  arm group type: Experimental
  description: Women will receive a first-void urine self-sampling study package at home.
  The study package will include an invitation letter/informed consent form, information brochure, first-void urine self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.
  arm group label: Opt-in first-void urine
  arm group type: Experimental
  description: Women will receive a letter at home with instructions how to order (via phone, e-mail, or webform) a first-void urine self-sampling study package.
  The study package will include an invitation letter/informed consent form, information brochure, first-void urine self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.
  arm group label: Opt-out vaginal self-sample
  arm group type: Experimental
  description: Women will receive a vaginal self-sampling study package at home.
  The study package will include an invitation letter/informed consent form, information brochure, vaginal self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.
  arm group label: Opt-in vaginal self-sample
  arm group type: Experimental
  description: Women will receive a letter at home with instructions how to order (via phone, e-mail, or webform) a vaginal self-sampling study package.
  The study package will include an invitation letter/informed consent form, information brochure, vaginal self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.
  intervention type: Device
  intervention name: Colli-Pee Small Volumes
  description: Women will self-collect a first-void urine sample at home upon receipt of the study package using the Colli-Pee Small Volumes (10 mL) device (Novosanis, Belgium). The collector tube is prefilled with a preservative (UCM, Novosanis, Belgium). Women will send the collector vial containing first-void urine along with the informed consent form to the laboratory at University of Antwerp using the prestamped envelope.
  arm group label: Opt-in first-void urine
  arm group label: Opt-out first-void urine
  intervention type: Device
  intervention name: Evalyn Brush
  description: Women will self-collect a vaginal sample at home upon receipt of the study package using the Evalyn Brush device (Rovers Medical Devices, The Netherlands). Women will send the used brush along with the informed consent form to the laboratory at University of Antwerp using the prestamped envelope.
  arm group label: Opt-in vaginal self-sample
  arm group label: Opt-out vaginal self-sample
  criteria: 
  gender: Female
  minimum age: 30 Years
  maximum age: 64 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Pierre Van Damme, MD, PhD
  role: Principal Investigator
  affiliation: Universiteit Antwerpen
  facility: 
  country: Belgium
  responsible party type: Principal Investigator
  investigator affiliation: Universiteit Antwerpen
  investigator full name: Pierre Van Damme
  investigator title: Principal Investigator
  mesh term: Uterine Cervical Neoplasms
  mesh term: Papilloma
  mesh term: Uterine Cervical Dysplasia
  sharing ipd: No