<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/NCT03788850</url>
  </required_header>
  <id_info>
    <org_study_id>12102018INC</org_study_id>
    <nct_id>NCT03788850</nct_id>
  </id_info>
  <brief_title>Factors Associated With Residual Disease In The Central Cone</brief_title>
  <acronym>FARDCC</acronym>
  <official_title>Factors Associated With Residual Disease In The Central Cone: A Disease Prediction Model</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Cancerología</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institute of Cancerología</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>
      Cervical conization using the loop electrosurgical excision procedure (LEEP) is the standard&#xD;
      treatment for patients with high-grade cervical intraepithelial neoplasia. Several studies&#xD;
      have shown that excising a central cone reduces the rate of positive endocervical margins.&#xD;
      The purpose of this study is to identify clinicopathological factors associated with residual&#xD;
      disease in the central cone and to develop a predictive model to better determine which&#xD;
      patients may require this additional procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study pretends to create a retrospective database including all patient who underwent a&#xD;
      loop electrosurgical excision procedure by treatment for high-grade cervical intraepithelial&#xD;
      neoplasia and create a a predictive model for top-hat resection in patients with high grade&#xD;
      CIN&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2006</start_date>
  <completion_date type="Actual">August 15, 2016</completion_date>
  <primary_completion_date type="Actual">December 31, 2011</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>Identify the clinical and pathologic factors associated with residual disease</measure>
    <time_frame>1month</time_frame>
    <description>Whit the variables identified as factors associated with the residual disease develop a predictive model to determine which individuals may require additional procedures in the uterine cervix to ensure negative margins.</description>
  </primary_outcome>
  <enrollment type="Actual">397</enrollment>
  <condition>Cervical Intraepithelial Neoplasia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients who underwent a cervical cone procedure at the Dysplasia Clinic of the Instituto&#xD;
        Nacional de Cancerologia in Mexico City&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who underwent a loop electrosurgical excision procedure (LEEP)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a diagnosis of micro-invasion or nonsquamous histology&#xD;
&#xD;
          -  less than six months of follow-up&#xD;
&#xD;
          -  incomplete information in their clinical charts.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>November 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>August 25, 2020</last_update_submitted>
  <last_update_submitted_qc>August 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Institute of Cancerología</investigator_affiliation>
    <investigator_full_name>David Cantu</investigator_full_name>
    <investigator_title>Chief of clinical trial departament</investigator_title>
  </responsible_party>
  <keyword>residual disease</keyword>
  <keyword>central cone</keyword>
  <keyword>predictive model</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Dysplasia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03788850
org study id: 12102018INC
nct id: NCT03788850
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cervical conization using the loop electrosurgical excision procedure (LEEP) is the standard
      treatment for patients with high-grade cervical intraepithelial neoplasia. Several studies
      have shown that excising a central cone reduces the rate of positive endocervical margins.
      The purpose of this study is to identify clinicopathological factors associated with residual
      disease in the central cone and to develop a predictive model to better determine which
      patients may require this additional procedure.
This study pretends to create a retrospective database including all patient who underwent a
      loop electrosurgical excision procedure by treatment for high-grade cervical intraepithelial
      neoplasia and create a a predictive model for top-hat resection in patients with high grade
      CIN
observational model: Cohort
time perspective: Retrospective
measure: Identify the clinical and pathologic factors associated with residual disease
time frame: 1month
description: Whit the variables identified as factors associated with the residual disease develop a predictive model to determine which individuals may require additional procedures in the uterine cervix to ensure negative margins.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: National Institute of Cancerología
investigator full name: David Cantu
investigator title: Chief of clinical trial departament
mesh term: Uterine Cervical Dysplasia
sharing ipd: Undecided