<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/NCT04423679</url>
  </required_header>
  <id_info>
    <org_study_id>NCR191015</org_study_id>
    <nct_id>NCT04423679</nct_id>
  </id_info>
  <brief_title>The Selfie Study- Assessing Novel Markers for Cervical Cancer Screening From Self-collected Samples</brief_title>
  <acronym>SELFIE</acronym>
  <official_title>The Selfie Study- Assessing Novel Markers for Cervical Cancer Screening From Self-collected Samples</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>George Washington University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>George Washington University</source>
  <oversight_info>
    <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 primarily caused by Human Papillomaviruses (HPV). Testing for HPV in&#xD;
      cervical samples is now an option for cervical cancer screening. HPV can also be tested from&#xD;
      self-collected samples which may help to improve access to screening, since it does not&#xD;
      require a doctor visit. However, many women will test positive for HPV who are not at high&#xD;
      risk for cervical cancer. Therefore, additional (&quot;triage&quot;) tests are needed to determine&#xD;
      which women testing HPV-positive require additional clinical workup. For self sampling, a&#xD;
      triage test that could be measured from the same initial sample without requiring a follow-up&#xD;
      visit to the doctor would be an ideal strategy. The purpose of this study is to determine&#xD;
      whether a new HPV test that measures changes in HPV DNA can be used to triage HPV-positive&#xD;
      women using self collected samples. This study will enroll 1,000 women who are undergoing&#xD;
      cervical cancer screening at the George Washington University. Women will be asked to take a&#xD;
      self-collected sample prior to their clinic visit. The investigators will evaluate the&#xD;
      clinical accuracy of the new HPV triage test in self-collected samples and compare the&#xD;
      accuracy of the test in samples collected by the clinician.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Worldwide, cervical cancer remains the fourth most common cancer and fourth leading cause of&#xD;
      cancer deaths among women, with the greatest burden occurring in low-resource settings that&#xD;
      lack effective screening and treatment. Even in the United States (U.S.), where Pap cytology&#xD;
      screening has resulted in dramatic declines in cervical cancer incidence and mortality,&#xD;
      thousands of new cases and related-deaths still occur every year, most commonly among&#xD;
      underserved women who face barriers to accessing screening and/or treatment. The recent&#xD;
      implementation of human papillomavirus (HPV) DNA testing as a primary strategy for cervical&#xD;
      cancer screening has the potential to alleviate these disparities by improving the&#xD;
      sensitivity for cervical precancer detection compared to Pap cytology, while providing&#xD;
      greater long term reassurance following a negative HPV test. Moreover, HPV testing can be&#xD;
      successfully performed on self-collected specimens, offering the possibility of expanding&#xD;
      access to cervical cancer screening among hard-to-reach, underserved women.&#xD;
&#xD;
      Despite the many advantages of primary HPV screening, the current challenge is optimizing&#xD;
      triage testing to determine who among the many women testing HPV positive are at high-risk&#xD;
      and require immediate colposcopy referral or treatment, while avoiding unnecessary harms&#xD;
      among women at low-risk. A molecular triage test that can be conducted from the same primary&#xD;
      screening sample (i.e., reflex testing) is particularly attractive for both high-and&#xD;
      low-resource settings, particularly if it works from self-collected samples. Previously, DNA&#xD;
      methylation of candidate host cell genes has been evaluated in self-collected samples and&#xD;
      achieved acceptable performance for triage of HPV-positive women. In studies using clinician&#xD;
      collected samples, there is a suggestion that methylation of carcinogenic HPV genotypes has&#xD;
      better clinical performance (higher sensitivity/specificity) compared to host gene&#xD;
      methylation; however, HPV methylation has not been evaluated in self-collected specimens.&#xD;
      Because HPV DNA is present in only a small subset of infected cells in the lower genital&#xD;
      tract, particularly in cervical precancers, it is likely that the signal-to noise ratio in&#xD;
      self-collected samples is better for HPV compared to host gene methylation, resulting in&#xD;
      improved specificity for cervical precancer detection. Evaluating the feasibility of HPV DNA&#xD;
      methylation testing from self-collected samples is essential for determining the extent to&#xD;
      which this assay can address the critical need for HPV triage in high- and low resource&#xD;
      settings. In collaboration with the Cancer Genome Research Laboratory, a high-throughput,&#xD;
      low-cost next-generation bisulfite sequencing assay that detects methylation of the 12 most&#xD;
      carcinogenic HPV genotypes has been developed. Further, this assay includes a panel of host&#xD;
      genes, including those that have been previously evaluated in self-collected specimens. The&#xD;
      proposal is to test this assay in paired self and clinician-collected samples from 1,000&#xD;
      women enrolled in an ongoing prospective study of women undergoing cervical cancer screening&#xD;
      and colposcopy at the George Washington University (GWU). The hypothesis is that HPV and host&#xD;
      DNA methylation will show non-inferior sensitivity and specificity for detection of cervical&#xD;
      precancer in self-collected compared to clinician-collected samples and that HPV methylation&#xD;
      will have higher absolute specificity compared to host methylation in both sample types.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 15, 2020</start_date>
  <completion_date type="Anticipated">August 2025</completion_date>
  <primary_completion_date type="Anticipated">August 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluating the relative sensitivity and specificity of HPV methylation testing from collected samples</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Evaluate the relative sensitivity and specificity of HPV methylation testing from self-collected compared to clinician-collected samples for detection of cervical precancer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluating the relative sensitivity and specificity of host gene methylation testing from collected samples</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Evaluate the relative sensitivity and specificity of host gene methylation testing from self-collected compared to clinician-collected samples for detection of cervical precancer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparing the absolute sensitivity and specificity of HPV versus host gene methylation testing</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Compare the absolute sensitivity and specificity of HPV versus host gene methylation testing for the detection of cervical pre-cancer in both self-collected and clinician-collected samples</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Human Papilloma Virus</condition>
  <condition>Cervical Cancer</condition>
  <condition>CIN 2/3</condition>
  <arm_group>
    <arm_group_label>CIN2+</arm_group_label>
    <description>Cases of cervical precancer will include women diagnosed with cervical intraepithelial grades 2 or 3 (CIN2/3) or adenocarcinoma in situ (AIS). If any women are diagnosed with cancer in the study, they will be included in this group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>&lt; CIN2</arm_group_label>
    <description>Non-cases will include those with &lt;CIN2 on colposcopy/biopsy and women who did not have an indication for colposcopy (because of a negative screening test).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Evalyn Brush</intervention_name>
    <description>a standard brush-based cervicovaginal self-collection device</description>
    <arm_group_label>&lt; CIN2</arm_group_label>
    <arm_group_label>CIN2+</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women undergoing routine screening with Pap cytology and HPV testing or colposcopy at the&#xD;
        George Washington University (GWU). From this population, a representative subset of 1000&#xD;
        women for self-sampling and methylation testing (400 cases and 600 controls). Most controls&#xD;
        will come from the screening population, where we expect 85% to have negative HPV and&#xD;
        cytology results. The majority of cases will come from the colposcopy referral population.&#xD;
        Cases of cervical precancer will include women diagnosed with cervical intraepithelial&#xD;
        grades 2 or 3 (CIN2/3) or adenocarcinoma in situ (AIS). If any women are diagnosed with&#xD;
        cancer in the study, they will be included in the case group (CIN2+); however, we will also&#xD;
        perform sensitivity analyses excluding these women. Non-cases will include those with less&#xD;
        than CIN2 on colposcopy/biopsy and women who did not have an indication for colposcopy&#xD;
        (because of negative screening).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Age 30-69&#xD;
&#xD;
          -  Undergoing cervical cancer screening, diagnostic procedure (colposcopy), or treatment&#xD;
             (LEEP)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  History of Cervical Cancer&#xD;
&#xD;
          -  Prior hysterectomy&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Nicole Chappell, MD</last_name>
    <phone>202 741 2434</phone>
    <email>nChappell@mfa.gwu.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Medical Faculty Associates</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Radwa Aly</last_name>
      <email>raly@mfa.gwu.edu</email>
    </contact>
    <investigator>
      <last_name>Nicole Chappell, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>November 5, 2022</last_update_submitted>
  <last_update_submitted_qc>November 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>George Washington University</investigator_affiliation>
    <investigator_full_name>Nicole Chappell</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <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>
  </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/NCT04423679
org study id: NCR191015
nct id: NCT04423679
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Cervical cancer is primarily caused by Human Papillomaviruses (HPV). Testing for HPV in
      cervical samples is now an option for cervical cancer screening. HPV can also be tested from
      self-collected samples which may help to improve access to screening, since it does not
      require a doctor visit. However, many women will test positive for HPV who are not at high
      risk for cervical cancer. Therefore, additional ("triage") tests are needed to determine
      which women testing HPV-positive require additional clinical workup. For self sampling, a
      triage test that could be measured from the same initial sample without requiring a follow-up
      visit to the doctor would be an ideal strategy. The purpose of this study is to determine
      whether a new HPV test that measures changes in HPV DNA can be used to triage HPV-positive
      women using self collected samples. This study will enroll 1,000 women who are undergoing
      cervical cancer screening at the George Washington University. Women will be asked to take a
      self-collected sample prior to their clinic visit. The investigators will evaluate the
      clinical accuracy of the new HPV triage test in self-collected samples and compare the
      accuracy of the test in samples collected by the clinician.
Worldwide, cervical cancer remains the fourth most common cancer and fourth leading cause of
      cancer deaths among women, with the greatest burden occurring in low-resource settings that
      lack effective screening and treatment. Even in the United States (U.S.), where Pap cytology
      screening has resulted in dramatic declines in cervical cancer incidence and mortality,
      thousands of new cases and related-deaths still occur every year, most commonly among
      underserved women who face barriers to accessing screening and/or treatment. The recent
      implementation of human papillomavirus (HPV) DNA testing as a primary strategy for cervical
      cancer screening has the potential to alleviate these disparities by improving the
      sensitivity for cervical precancer detection compared to Pap cytology, while providing
      greater long term reassurance following a negative HPV test. Moreover, HPV testing can be
      successfully performed on self-collected specimens, offering the possibility of expanding
      access to cervical cancer screening among hard-to-reach, underserved women.

      Despite the many advantages of primary HPV screening, the current challenge is optimizing
      triage testing to determine who among the many women testing HPV positive are at high-risk
      and require immediate colposcopy referral or treatment, while avoiding unnecessary harms
      among women at low-risk. A molecular triage test that can be conducted from the same primary
      screening sample (i.e., reflex testing) is particularly attractive for both high-and
      low-resource settings, particularly if it works from self-collected samples. Previously, DNA
      methylation of candidate host cell genes has been evaluated in self-collected samples and
      achieved acceptable performance for triage of HPV-positive women. In studies using clinician
      collected samples, there is a suggestion that methylation of carcinogenic HPV genotypes has
      better clinical performance (higher sensitivity/specificity) compared to host gene
      methylation; however, HPV methylation has not been evaluated in self-collected specimens.
      Because HPV DNA is present in only a small subset of infected cells in the lower genital
      tract, particularly in cervical precancers, it is likely that the signal-to noise ratio in
      self-collected samples is better for HPV compared to host gene methylation, resulting in
      improved specificity for cervical precancer detection. Evaluating the feasibility of HPV DNA
      methylation testing from self-collected samples is essential for determining the extent to
      which this assay can address the critical need for HPV triage in high- and low resource
      settings. In collaboration with the Cancer Genome Research Laboratory, a high-throughput,
      low-cost next-generation bisulfite sequencing assay that detects methylation of the 12 most
      carcinogenic HPV genotypes has been developed. Further, this assay includes a panel of host
      genes, including those that have been previously evaluated in self-collected specimens. The
      proposal is to test this assay in paired self and clinician-collected samples from 1,000
      women enrolled in an ongoing prospective study of women undergoing cervical cancer screening
      and colposcopy at the George Washington University (GWU). The hypothesis is that HPV and host
      DNA methylation will show non-inferior sensitivity and specificity for detection of cervical
      precancer in self-collected compared to clinician-collected samples and that HPV methylation
      will have higher absolute specificity compared to host methylation in both sample types.
observational model: Case-Control
time perspective: Prospective
measure: Evaluating the relative sensitivity and specificity of HPV methylation testing from collected samples
time frame: Up to 24 months
description: Evaluate the relative sensitivity and specificity of HPV methylation testing from self-collected compared to clinician-collected samples for detection of cervical precancer.
measure: Evaluating the relative sensitivity and specificity of host gene methylation testing from collected samples
time frame: Up to 24 months
description: Evaluate the relative sensitivity and specificity of host gene methylation testing from self-collected compared to clinician-collected samples for detection of cervical precancer.
measure: Comparing the absolute sensitivity and specificity of HPV versus host gene methylation testing
time frame: Up to 24 months
description: Compare the absolute sensitivity and specificity of HPV versus host gene methylation testing for the detection of cervical pre-cancer in both self-collected and clinician-collected samples
arm group label: CIN2+
description: Cases of cervical precancer will include women diagnosed with cervical intraepithelial grades 2 or 3 (CIN2/3) or adenocarcinoma in situ (AIS). If any women are diagnosed with cancer in the study, they will be included in this group.
arm group label: < CIN2
description: Non-cases will include those with <CIN2 on colposcopy/biopsy and women who did not have an indication for colposcopy (because of a negative screening test).
intervention type: Device
intervention name: Evalyn Brush
description: a standard brush-based cervicovaginal self-collection device
arm group label: < CIN2
arm group label: CIN2+
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 30 Years
maximum age: 69 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nicole Chappell, MD
phone: 202 741 2434
email: nChappell@mfa.gwu.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: George Washington University
investigator full name: Nicole Chappell
investigator title: Principle Investigator
mesh term: Uterine Cervical Neoplasms
mesh term: Papilloma
sharing ipd: No