<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/NCT04480866</url>
  </required_header>
  <id_info>
    <org_study_id>B300201940120</org_study_id>
    <nct_id>NCT04480866</nct_id>
  </id_info>
  <brief_title>CASUS: Improved and Quality Assured Collection of First-void Urine</brief_title>
  <acronym>CASUS-WP1</acronym>
  <official_title>Developing a Complete Cervical Cancer Screening Solution Based on First-void Urine Self-sampling: Improved and Quality Assured Collection of First-void Urine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universiteit Antwerpen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Amsterdam UMC, location VUmc</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Novosanis NV</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Self-screen B.V.</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 goal of the overall CASUS project is to develop the first fully molecular integrated&#xD;
      cervical cancer screening approach, based on first-void urine as an easily accessible and&#xD;
      non-invasive source of biomarkers. In contrast to current screening modalities, the CASUS&#xD;
      approach will identify women with clinically relevant disease in need of treatment using only&#xD;
      a single sample that can be collected at home (one-step triage).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CASUS work package 1 (WP1): To accommodate for the detection of biomarkers in first-void&#xD;
      urine, a next-generation first-void urine collection device is necessary, which includes&#xD;
      internal process control, novel collector tubes for collection of smaller urine volumes, and&#xD;
      integration of a non-toxic nucleic acid preservative.&#xD;
&#xD;
      Hereto, new generations of the Colli-Pee® (Novosanis) first-void urine collector allowing&#xD;
      collection of smaller volumes (Colli-Pee Small Volumes 4 and 10 mL) next to the 'standard'&#xD;
      Colli-Pee FV5000 (20 mL) first-void urine collector will be developed and validated. The&#xD;
      optimal urine volume needed for detection of host and viral biomarkers, as well as&#xD;
      optimization of the nucleic acid preservative solution by introduction of a sample/extraction&#xD;
      validation control (non-human DNA internal control (DNA IC)) will be evaluated by measuring&#xD;
      the concentration of human DNA, HPV DNA, and the DNA IC in all first-void urine samples using&#xD;
      different DNA extraction protocols.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 30, 2019</start_date>
  <completion_date type="Actual">November 27, 2019</completion_date>
  <primary_completion_date type="Actual">November 25, 2019</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Human DNA (GAPDH)</measure>
    <time_frame>Evaluation/testing when all samples are collected [1 year]</time_frame>
    <description>Comparison of human DNA (GAPDH) concentrations [cycle threshold values] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured by quantitative PCR (qPCR).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Internal control DNA (IC DNA)</measure>
    <time_frame>Evaluation/testing when all samples are collected [1 year]</time_frame>
    <description>Comparison of internal control DNA (IC DNA) concentrations [cycle threshold values] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured by quantitative PCR (qPCR).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Human DNA reference gene (ACTB)</measure>
    <time_frame>Evaluation/testing when all samples are collected [1 year]</time_frame>
    <description>Comparison of human DNA reference gene (ACTB) concentrations [cycle threshold values] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured by quantitative methylation specific PCR (qMSP).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Human DNA (Beta-globin)</measure>
    <time_frame>Evaluation/testing when all samples are collected [1 year]</time_frame>
    <description>Comparison of human DNA (Beta-globin) concentrations [cycle threshold values] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured using the HPV-risk assay (Self-Screen BV).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68))</measure>
    <time_frame>Evaluation/testing when all samples are collected [1 year]</time_frame>
    <description>Comparison of HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68)) positivity (+/-) and concentrations [cycle threshold values] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured using the HPV-risk assay (Self-Screen BV).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Cervical Cancer</condition>
  <condition>Cervical Intraepithelial Neoplasia</condition>
  <condition>Human Papilloma Virus</condition>
  <condition>HPV-Related Cervical Carcinoma</condition>
  <condition>Urine</condition>
  <arm_group>
    <arm_group_label>First-void urine collection</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Women self-collect three first-void urine samples (random order) at home.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Colli-Pee® (FV5000 and Small Volumes)</intervention_name>
    <description>Colli-Pee® device (Novosanis, Belgium) attached to collector tubes prefilled with a non-toxic nucleic acid preservative (including an internal process control). The collector tubes differ in size to collect a total sample volume of 4, 10, and 20 mL.&#xD;
Each participant will collect three urine samples using the Colli-Pee Small Volumes 4 and 10 mL, and the Colli-Pee FV5000 (20 mL) device, in a random order.</description>
    <arm_group_label>First-void urine collection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  18 years and older&#xD;
&#xD;
          -  Women with a high-risk HPV positive test result within six months prior to study&#xD;
             enrolment.&#xD;
&#xD;
          -  Giving informed consent to the research team to contact his/her general practitioner&#xD;
             and/or gynaecologist to access details of the participants HPV test results and&#xD;
             cervical screening history.&#xD;
&#xD;
          -  Able to understand the information brochure/what the study is about.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women that underwent hysterectomy or were treated for cervical (pre)cancer lesions&#xD;
             within the previous six months prior to study enrolment.&#xD;
&#xD;
          -  Participating in another interventional clinical study (where e.g. a medical device,&#xD;
             drug, or vaccine is evaluated) at the same time of participating in this study.&#xD;
             Participation in another observational or low-interventional clinical study at the&#xD;
             same time is allowed.&#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_official>
    <last_name>Pierre Van Damme, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universiteit Antwerpen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alex Vorsters, Ir, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Universiteit Antwerpen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Severien Van Keer, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Universiteit Antwerpen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Laura Téblick, Ir</last_name>
    <role>Study Chair</role>
    <affiliation>Universiteit Antwerpen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for the Evaluation of Vaccination (CEV) - Vaccine &amp; Infectious Disease Institute (VAXINFECTIO) - University of Antwerp</name>
      <address>
        <city>Wilrijk</city>
        <state>Antwerpen</state>
        <zip>2610</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 17, 2020</last_update_submitted>
  <last_update_submitted_qc>July 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</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>Screening</keyword>
  <keyword>Triage</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>


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/NCT04480866
org study id: B300201940120
nct id: NCT04480866
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of the overall CASUS project is to develop the first fully molecular integrated
      cervical cancer screening approach, based on first-void urine as an easily accessible and
      non-invasive source of biomarkers. In contrast to current screening modalities, the CASUS
      approach will identify women with clinically relevant disease in need of treatment using only
      a single sample that can be collected at home (one-step triage).
CASUS work package 1 (WP1): To accommodate for the detection of biomarkers in first-void
      urine, a next-generation first-void urine collection device is necessary, which includes
      internal process control, novel collector tubes for collection of smaller urine volumes, and
      integration of a non-toxic nucleic acid preservative.

      Hereto, new generations of the Colli-Pee® (Novosanis) first-void urine collector allowing
      collection of smaller volumes (Colli-Pee Small Volumes 4 and 10 mL) next to the 'standard'
      Colli-Pee FV5000 (20 mL) first-void urine collector will be developed and validated. The
      optimal urine volume needed for detection of host and viral biomarkers, as well as
      optimization of the nucleic acid preservative solution by introduction of a sample/extraction
      validation control (non-human DNA internal control (DNA IC)) will be evaluated by measuring
      the concentration of human DNA, HPV DNA, and the DNA IC in all first-void urine samples using
      different DNA extraction protocols.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Human DNA (GAPDH)
time frame: Evaluation/testing when all samples are collected [1 year]
description: Comparison of human DNA (GAPDH) concentrations [cycle threshold values] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured by quantitative PCR (qPCR).
measure: Internal control DNA (IC DNA)
time frame: Evaluation/testing when all samples are collected [1 year]
description: Comparison of internal control DNA (IC DNA) concentrations [cycle threshold values] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured by quantitative PCR (qPCR).
measure: Human DNA reference gene (ACTB)
time frame: Evaluation/testing when all samples are collected [1 year]
description: Comparison of human DNA reference gene (ACTB) concentrations [cycle threshold values] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured by quantitative methylation specific PCR (qMSP).
measure: Human DNA (Beta-globin)
time frame: Evaluation/testing when all samples are collected [1 year]
description: Comparison of human DNA (Beta-globin) concentrations [cycle threshold values] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured using the HPV-risk assay (Self-Screen BV).
measure: HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68))
time frame: Evaluation/testing when all samples are collected [1 year]
description: Comparison of HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68)) positivity (+/-) and concentrations [cycle threshold values] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured using the HPV-risk assay (Self-Screen BV).
arm group label: First-void urine collection
arm group type: Other
description: Women self-collect three first-void urine samples (random order) at home.
intervention type: Device
intervention name: Colli-Pee® (FV5000 and Small Volumes)
description: Colli-Pee® device (Novosanis, Belgium) attached to collector tubes prefilled with a non-toxic nucleic acid preservative (including an internal process control). The collector tubes differ in size to collect a total sample volume of 4, 10, and 20 mL.
Each participant will collect three urine samples using the Colli-Pee Small Volumes 4 and 10 mL, and the Colli-Pee FV5000 (20 mL) device, in a random order.
arm group label: First-void urine collection
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pierre Van Damme, MD, PhD
role: Principal Investigator
affiliation: Universiteit Antwerpen
last name: Alex Vorsters, Ir, PhD
role: Study Chair
affiliation: Universiteit Antwerpen
last name: Severien Van Keer, PhD
role: Study Chair
affiliation: Universiteit Antwerpen
last name: Laura Téblick, Ir
role: Study Chair
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