<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/NCT03749720</url>
  </required_header>
  <id_info>
    <org_study_id>U416</org_study_id>
    <nct_id>NCT03749720</nct_id>
  </id_info>
  <brief_title>HPV in Blood Samples From Cervical Cancer Patients.</brief_title>
  <official_title>Can Digital Droplet PCR (ddPCR) on Blood Samples From Patients With HPV Related Cancers Become a Reality in Cancer Treatment and Monitoring?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</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>
      By means of digital droplet PCR (ddPCR), this study examines blood samples from patients&#xD;
      newly diagnosed with cervical cancer to investigate whether it is possible to measure the&#xD;
      presence and amount of HPV DNA in these blood samples. The first blood sample is taken at&#xD;
      time of diagnosis, and follow-up blood samples are collected during treatment- and follow-up&#xD;
      visits. We expect to find a correlation between the disease stage and the viral load and also&#xD;
      a decline in viral load after treatment. Furthermore, we hope that this method may serve as a&#xD;
      way of detecting disease recurrence earlier than what is possible today.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study hypothesises that in patients with HPV-related cervical cancer, HPV DNA may be&#xD;
      released into the bloodstream from tumor cells. These fragments of HPV DNA shed by tumor may&#xD;
      therefore be measured in blood samples from the patients. By using the same setting as for&#xD;
      real-time PCR with PCR primers and probes for fluorescence detection, the study uses digital&#xD;
      droplet PCR (ddPCR), a method based on dilution and partitioning of the blood sample in many&#xD;
      reaction chambers or droplets, to measure absolute quantities of HPV DNA fragments in blood&#xD;
      samples from women with different stages of cervical cancer. Patients are recruited at the&#xD;
      time of diagnosis, where a baseline blood sample is collected. Follow-up blood samples are&#xD;
      collected during treatment and at follow-up visits up to two years after the diagnosis. We&#xD;
      expect the HPV DNA load to decrease after treatment, and if an increase in viral load is&#xD;
      detected during follow-up, we expect this to be an early sign of a disease recurrence. The&#xD;
      method may therefore become an effective monitoring tool in these patients in terms of&#xD;
      detecting a ongoing disease recurrence, which gives us the chance to intervene and treat&#xD;
      these patients before the disease becomes too disseminated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2018</start_date>
  <completion_date type="Actual">October 30, 2022</completion_date>
  <primary_completion_date type="Actual">October 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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Case-control study with 141 case patients newly diagnosed cervical cancer and a control group of 10 healthy women with no prior cervical dysplasia and 25 women with cervical dysplasia (CIN3), respectively.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HPV DNA</measure>
    <time_frame>Two years</time_frame>
    <description>A qualitative and quantitative measure of HPV DNA in blood samples.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">141</enrollment>
  <condition>HPV-Related Carcinoma</condition>
  <condition>HPV-Related Malignancy</condition>
  <arm_group>
    <arm_group_label>Cervical cancer patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Baseline- and follow-up blood samples are collected from the cervical cancer patients at time of diagnosis and during treatment and clinical follow-up. HPV DNA is measured in these samples.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <description>Blood sample taken from cervical cancer patients at time of diagnosis (baseline) and follow-up visits.</description>
    <arm_group_label>Cervical cancer patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria cases:&#xD;
&#xD;
          -  Diagnosed with cervical cancer ≥ stage 1B between june 2018 and june 2020&#xD;
&#xD;
          -  &gt; 18 years of age at the time of diagnosis&#xD;
&#xD;
          -  There must be available cervical tissue material from the patient to analyse for HPV&#xD;
&#xD;
        Inclusion Criteria healthy controls&#xD;
&#xD;
          -  Women &gt; 18 years with no prior history of any cervical dysplasia&#xD;
&#xD;
        Inclusion Criteria CIN3 controls&#xD;
&#xD;
          -  Women &gt; 18 years&#xD;
&#xD;
          -  Must have a histologically verified severe cervical dysplasia (CIN3)&#xD;
&#xD;
          -  Is admitted for cervical conisation&#xD;
&#xD;
        Exclusion Criteria cases:&#xD;
&#xD;
          -  &lt; 18 years of age at time of cervical cancer diagnosis&#xD;
&#xD;
          -  Cervical cancer &lt; stage 1B&#xD;
&#xD;
        Exclusion Criteria healthy controls:&#xD;
&#xD;
          -  &lt; 18 years of age&#xD;
&#xD;
          -  Prior cervical dysplasia&#xD;
&#xD;
        Exclusion Criteria CIN3 controls:&#xD;
&#xD;
          -  &lt; 18 years of age&#xD;
&#xD;
          -  Women with only low grades of cervical dysplasia (CIN1 or CIN2)&#xD;
&#xD;
          -  Women with HPV-negative cervical biopsies&#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>Sara Bønløkke, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aarhus University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecology</name>
      <address>
        <city>Aarhus</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecolgy</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 3, 2022</last_update_submitted>
  <last_update_submitted_qc>November 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cervical Cancer</keyword>
  <keyword>HPV</keyword>
  <keyword>Pathology</keyword>
  <keyword>ddPCR</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT03749720
org study id: U416
nct id: NCT03749720
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
By means of digital droplet PCR (ddPCR), this study examines blood samples from patients
      newly diagnosed with cervical cancer to investigate whether it is possible to measure the
      presence and amount of HPV DNA in these blood samples. The first blood sample is taken at
      time of diagnosis, and follow-up blood samples are collected during treatment- and follow-up
      visits. We expect to find a correlation between the disease stage and the viral load and also
      a decline in viral load after treatment. Furthermore, we hope that this method may serve as a
      way of detecting disease recurrence earlier than what is possible today.
This study hypothesises that in patients with HPV-related cervical cancer, HPV DNA may be
      released into the bloodstream from tumor cells. These fragments of HPV DNA shed by tumor may
      therefore be measured in blood samples from the patients. By using the same setting as for
      real-time PCR with PCR primers and probes for fluorescence detection, the study uses digital
      droplet PCR (ddPCR), a method based on dilution and partitioning of the blood sample in many
      reaction chambers or droplets, to measure absolute quantities of HPV DNA fragments in blood
      samples from women with different stages of cervical cancer. Patients are recruited at the
      time of diagnosis, where a baseline blood sample is collected. Follow-up blood samples are
      collected during treatment and at follow-up visits up to two years after the diagnosis. We
      expect the HPV DNA load to decrease after treatment, and if an increase in viral load is
      detected during follow-up, we expect this to be an early sign of a disease recurrence. The
      method may therefore become an effective monitoring tool in these patients in terms of
      detecting a ongoing disease recurrence, which gives us the chance to intervene and treat
      these patients before the disease becomes too disseminated.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Case-control study with 141 case patients newly diagnosed cervical cancer and a control group of 10 healthy women with no prior cervical dysplasia and 25 women with cervical dysplasia (CIN3), respectively.
primary purpose: Prevention
masking: None (Open Label)
measure: HPV DNA
time frame: Two years
description: A qualitative and quantitative measure of HPV DNA in blood samples.
arm group label: Cervical cancer patients
arm group type: Other
description: Baseline- and follow-up blood samples are collected from the cervical cancer patients at time of diagnosis and during treatment and clinical follow-up. HPV DNA is measured in these samples.
intervention type: Other
intervention name: Blood sample
description: Blood sample taken from cervical cancer patients at time of diagnosis (baseline) and follow-up visits.
arm group label: Cervical cancer patients
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sara Bønløkke, MD
role: Principal Investigator
affiliation: Aarhus University Hospital
facility: 
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: No