<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/NCT02217215</url>
  </required_header>
  <id_info>
    <org_study_id>CLIN-4-CLP_0</org_study_id>
    <nct_id>NCT02217215</nct_id>
  </id_info>
  <brief_title>Initial Study With the CNDS Advanced Cervical Scan to Recalibrate Spectral Data for Use in Future Screening Studies</brief_title>
  <acronym>Spectral</acronym>
  <official_title>Initial Study With the CNDS Advanced Cervical Scan to Recalibrate Spectral Data for Use in Future Screening Studies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guided Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guided Therapeutics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate whether fluorescence and reflectance spectroscopy&#xD;
      can improve the ability to detect the presence of premalignant lesions on the cervix.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects (approximately 500) will be initially enrolled from a general screening population&#xD;
      in the first phase, and during the second phase from the colposcopy clinic population&#xD;
      (approximately 300) based on their referral abnormal Pap cytology conducted within 120-days&#xD;
      in order to achieve a statistically viable number of normal women, women with Cervical&#xD;
      Intra-epithelial Neoplasia (CIN1/2) and women with CIN3+, as described in Section 6.1,&#xD;
      &quot;Cervical Cytology Enrollment Targets&quot;. After the Cervical Neoplasia Detection System (CNDS)&#xD;
      test, a sample for Hybrid Capture 2 Human papillomavirus (HPV) testing and liquid cytology&#xD;
      will be collected in addition to colposcopy and biopsy, if indicated.&#xD;
&#xD;
      A key component of effective screening studies designed to evaluate new detection modalities&#xD;
      is verification of the gold standard comparison by which estimates of sensitivity and&#xD;
      specificity are generated. In the case of screening studies in general and studies of&#xD;
      cervical disease detection in particular, the avoidance of verification bias is a priority.&#xD;
      For the purposes of the proposed study, CIN3 or cancer (CIN3+) must be verified or&#xD;
      adjudicated by multiple histopathologists. Results for women with CIN1 or CIN2 will be&#xD;
      confirmed histopathologically and analyzed as a separate subgroup because these lesions often&#xD;
      regress to normal in certain populations and tend to cause disagreement among&#xD;
      histopathologists. In order to verify absence of disease (i.e., CIN1 or less severe), the&#xD;
      investigators will not rely on histopathology, as it would not be ethical to perform multiple&#xD;
      biopsies or excisional procedures to obtain a tissue sample for histopathology. Instead,&#xD;
      women will be considered normal if they have negative referral cytology, are free of high&#xD;
      risk HPV and are colposcopically normal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic accuracy including sensitivity, specificity and predictive values</measure>
    <time_frame>for each participant approximately 30 days to collect data, no follow up data collected</time_frame>
    <description>Collect clinical data for re-calibrating the processing of spectral data from the CNDS for eventual use as a primary screening modality. Resampling or other cross validation methods will be used to estimate the sensitivity, specificity and predictive values of a screening algorithm based on the recalibrated spectral data. These estimates will be used to compare with those of existing screening and diagnostic modalities such as Pap based cytopathology, HPV DNA testing and/or VIA (Visual Inspection with Acetic Acid).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Events as a Measure of Safety and Tolerability</measure>
    <time_frame>30 days, no follow up inteneded</time_frame>
    <description>Is the CNDS safe when used as directed and that the test procedure is accepted by both physicians and their patients.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">800</enrollment>
  <condition>Cervical Disease</condition>
  <arm_group>
    <arm_group_label>Negative and Referral Cytology Results</arm_group_label>
    <description>CNDS Advanced Cervical Scan Colposcopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CNDS Advanced Cervical Scan</intervention_name>
    <description>Subjects (approximately 500) will be initially enrolled from a general screening population in the first phase, and during the second phase from the colposcopy clinic population (approximately 300) based on their referral abnormal Pap cytology conducted within 120-days in order to achieve a statistically viable number of normal women, women with CIN1/2 and women with CIN3+, as described in Section 6.1, &quot;Cervical Cytology Enrollment Targets&quot;. After the CNDS test, a sample for Hybrid Capture 2 HPV testing and liquid cytology will be collected in addition to colposcopy and biopsy, if indicated.</description>
    <arm_group_label>Negative and Referral Cytology Results</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      cells from the cervix to collect and test for HPV&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        General screening population Scheduled for colposcopy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 21 or above&#xD;
&#xD;
          -  Able to read or understand and give informed consent&#xD;
&#xD;
          -  Negative pregnancy test or documentation of acceptable birth control&#xD;
&#xD;
          -  Willing to undergo colposcopy, cytology (if required) and HPV testing on day of study&#xD;
&#xD;
          -  Abnormal cytology result within 120 days of CNDS test for Phase 2 subjects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Menstruating&#xD;
&#xD;
          -  Previous cervical neoplasia&#xD;
&#xD;
          -  Prior hysterectomy&#xD;
&#xD;
          -  Conditions relating to the cervix that would render the test difficult to perform,&#xD;
             including but not limited to:&#xD;
&#xD;
        Excessive blood or mucus that cannot be removed Abnormal congenital cervix Unable to&#xD;
        tolerate speculum or CNDS single use cervical guide&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daron G Ferris, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Augusta University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Daron G Ferris, MD</last_name>
    <phone>706 721-2535</phone>
    <email>DFERRIS@gru.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Angela R Goebel, BS, CCRC</last_name>
    <phone>706 721-8944</phone>
    <email>agoebel@gru.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Georgia Regents University</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Daron G Ferris, MD</last_name>
      <phone>706-721-2535</phone>
      <email>DFERRIS@gru.edu</email>
    </contact>
    <contact_backup>
      <last_name>Angela R Goebel, BS</last_name>
      <phone>706 721-8944</phone>
      <email>agoebel@gru.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Daron G Ferris, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Twiggs LB, Chakhtoura NA, Ferris DG, Flowers LC, Winter ML, Sternfeld DR, Lashgari M, Burnett AF, Raab SS, Wilkinson EJ. Multimodal hyperspectroscopy as a triage test for cervical neoplasia: pivotal clinical trial results. Gynecol Oncol. 2013 Jul;130(1):147-51. doi: 10.1016/j.ygyno.2013.04.012. Epub 2013 Apr 13.</citation>
    <PMID>23591399</PMID>
  </results_reference>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>August 13, 2014</last_update_submitted>
  <last_update_submitted_qc>August 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Spectroscopy</keyword>
  <keyword>HPV</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT02217215
org study id: CLIN-4-CLP_0
nct id: NCT02217215
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate whether fluorescence and reflectance spectroscopy
      can improve the ability to detect the presence of premalignant lesions on the cervix.
Subjects (approximately 500) will be initially enrolled from a general screening population
      in the first phase, and during the second phase from the colposcopy clinic population
      (approximately 300) based on their referral abnormal Pap cytology conducted within 120-days
      in order to achieve a statistically viable number of normal women, women with Cervical
      Intra-epithelial Neoplasia (CIN1/2) and women with CIN3+, as described in Section 6.1,
      "Cervical Cytology Enrollment Targets". After the Cervical Neoplasia Detection System (CNDS)
      test, a sample for Hybrid Capture 2 Human papillomavirus (HPV) testing and liquid cytology
      will be collected in addition to colposcopy and biopsy, if indicated.

      A key component of effective screening studies designed to evaluate new detection modalities
      is verification of the gold standard comparison by which estimates of sensitivity and
      specificity are generated. In the case of screening studies in general and studies of
      cervical disease detection in particular, the avoidance of verification bias is a priority.
      For the purposes of the proposed study, CIN3 or cancer (CIN3+) must be verified or
      adjudicated by multiple histopathologists. Results for women with CIN1 or CIN2 will be
      confirmed histopathologically and analyzed as a separate subgroup because these lesions often
      regress to normal in certain populations and tend to cause disagreement among
      histopathologists. In order to verify absence of disease (i.e., CIN1 or less severe), the
      investigators will not rely on histopathology, as it would not be ethical to perform multiple
      biopsies or excisional procedures to obtain a tissue sample for histopathology. Instead,
      women will be considered normal if they have negative referral cytology, are free of high
      risk HPV and are colposcopically normal.
observational model: Cohort
time perspective: Retrospective
measure: Diagnostic accuracy including sensitivity, specificity and predictive values
time frame: for each participant approximately 30 days to collect data, no follow up data collected
description: Collect clinical data for re-calibrating the processing of spectral data from the CNDS for eventual use as a primary screening modality. Resampling or other cross validation methods will be used to estimate the sensitivity, specificity and predictive values of a screening algorithm based on the recalibrated spectral data. These estimates will be used to compare with those of existing screening and diagnostic modalities such as Pap based cytopathology, HPV DNA testing and/or VIA (Visual Inspection with Acetic Acid).
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: 30 days, no follow up inteneded
description: Is the CNDS safe when used as directed and that the test procedure is accepted by both physicians and their patients.
arm group label: Negative and Referral Cytology Results
description: CNDS Advanced Cervical Scan Colposcopy
intervention type: Device
intervention name: CNDS Advanced Cervical Scan
description: Subjects (approximately 500) will be initially enrolled from a general screening population in the first phase, and during the second phase from the colposcopy clinic population (approximately 300) based on their referral abnormal Pap cytology conducted within 120-days in order to achieve a statistically viable number of normal women, women with CIN1/2 and women with CIN3+, as described in Section 6.1, "Cervical Cytology Enrollment Targets". After the CNDS test, a sample for Hybrid Capture 2 HPV testing and liquid cytology will be collected in addition to colposcopy and biopsy, if indicated.
arm group label: Negative and Referral Cytology Results
cells from the cervix to collect and test for HPV
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Daron G Ferris, MD
role: Principal Investigator
affiliation: Augusta University
last name: Daron G Ferris, MD
phone: 706 721-2535
email: DFERRIS@gru.edu
last name: Angela R Goebel, BS, CCRC
phone: 706 721-8944
email: agoebel@gru.edu
facility: 
contact: 
contact backup: 
investigator: 
country: United States
citation: Twiggs LB, Chakhtoura NA, Ferris DG, Flowers LC, Winter ML, Sternfeld DR, Lashgari M, Burnett AF, Raab SS, Wilkinson EJ. Multimodal hyperspectroscopy as a triage test for cervical neoplasia: pivotal clinical trial results. Gynecol Oncol. 2013 Jul;130(1):147-51. doi: 10.1016/j.ygyno.2013.04.012. Epub 2013 Apr 13.
PMID: 23591399
responsible party type: Sponsor
mesh term: Uterine Cervical Diseases