xml: <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/NCT06039982</url>
    </required_header>
    <id_info>
      <org_study_id>Yang Sun</org_study_id>
      <nct_id>NCT06039982</nct_id>
    </id_info>
    <brief_title>A Diagnostic Nomogram for Predicting Vaginal Invasion in Cervical Cancer</brief_title>
    <official_title>Establish a New Noninvasive Diagnostic Model Based on Clinical Indicators to Evaluate the Vaginal Invasion in Cervical Cancer Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fujian Cancer Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fujian Cancer Hospital</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>
        This study aims to develop a diagnostic nomogram based on clinical factors with the&#xD;
        prediction values of vaginal invasion in cervical cancer to optimize the treatment plan and&#xD;
        surgical procedures.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Vaginal invasion is a crucial index participant in cervical cancer tumor staging and&#xD;
        prognosis prediction. However, the roles of vaginal invasion are overlooked in the&#xD;
        literature, compared with those of lymph node metastasis and parametrial invasion. As far as&#xD;
        we know, this study is novel to construct a nomogram to predict the probability of pathologic&#xD;
        vaginal invasion occurrence.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2026</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>vaginal invasion</measure>
      <time_frame>7 days after surgery</time_frame>
      <description>vaginal invasion is defined as cervix tumor disruption of the vaginal wall.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Cervix Carcinoma</condition>
    <arm_group>
      <arm_group_label>cervical cancer treated with surgery</arm_group_label>
      <description>The inclusion criteria were: (1) pathologically confirmed CC; (2) FIGO stage IB-IIA according to the result of physical examination and imaging; (3) abdominal MRI was performed within three weeks before surgery. Exclusion criteria were: (1) accompanied with other tumors. (2) with chronic infectious disease. (3) incomplete clinical data.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>no intervention</intervention_name>
      <description>no intervention</description>
      <arm_group_label>cervical cancer treated with surgery</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          we collect the medical data of cervical cancer patients in Fujian Cancer Hospital. All&#xD;
          patients received a standardized staging evaluation before radical hysterectomy with&#xD;
          bilateral pelvic lymphadenectomy, preoperative laboratory tests, abdominal MRI/CT, and&#xD;
          thoracic CT.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          (1) pathologically confirmed CC; (2) FIGO stage IB-IIA according to the result of physical&#xD;
          examination and imaging; (3) abdominal MRI/CT is performed within three weeks before&#xD;
          surgery.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          (1) accompanied with other tumors. (2) with chronic infectious disease. (3) incomplete&#xD;
          clinical data.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yang Sun, PHD</last_name>
      <phone>+8615959028989</phone>
      <email>sunyang@fjzlhospital.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Fujian Cancer Hospital</name>
        <address>
          <city>Fuzhou</city>
          <state>Fujian</state>
          <zip>350014</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yang Sun</last_name>
        <phone>15959028989</phone>
        <email>sunyang@fjzlhospital.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Salvo G, Odetto D, Saez Perrotta MC, Noll F, Perrotta M, Pareja R, Wernicke A, Ramirez PT. Measurement of tumor size in early cervical cancer: an ever-evolving paradigm. Int J Gynecol Cancer. 2020 Aug;30(8):1215-1223. doi: 10.1136/ijgc-2020-001436. Epub 2020 Jul 6.</citation>
      <PMID>32636272</PMID>
    </reference>
    <reference>
      <citation>Thomeer MG, Gerestein C, Spronk S, van Doorn HC, van der Ham E, Hunink MG. Clinical examination versus magnetic resonance imaging in the pretreatment staging of cervical carcinoma: systematic review and meta-analysis. Eur Radiol. 2013 Jul;23(7):2005-18. doi: 10.1007/s00330-013-2783-4. Epub 2013 Mar 1.</citation>
      <PMID>23455762</PMID>
    </reference>
    <reference>
      <citation>Wagner-Larsen KS, Lura N, Salvesen O, Halle MK, Forsse D, Trovik J, Smit N, Krakstad C, Haldorsen IS. Interobserver agreement and prognostic impact for MRI-based 2018 FIGO staging parameters in uterine cervical cancer. Eur Radiol. 2022 Sep;32(9):6444-6455. doi: 10.1007/s00330-022-08666-x. Epub 2022 Mar 24.</citation>
      <PMID>35332408</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Uterine Cervical 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>
  
  
text: 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/NCT06039982
  org study id: Yang Sun
  nct id: NCT06039982
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to develop a diagnostic nomogram based on clinical factors with the
        prediction values of vaginal invasion in cervical cancer to optimize the treatment plan and
        surgical procedures.
  Vaginal invasion is a crucial index participant in cervical cancer tumor staging and
        prognosis prediction. However, the roles of vaginal invasion are overlooked in the
        literature, compared with those of lymph node metastasis and parametrial invasion. As far as
        we know, this study is novel to construct a nomogram to predict the probability of pathologic
        vaginal invasion occurrence.
  observational model: Cohort
  time perspective: Prospective
  measure: vaginal invasion
  time frame: 7 days after surgery
  description: vaginal invasion is defined as cervix tumor disruption of the vaginal wall.
  arm group label: cervical cancer treated with surgery
  description: The inclusion criteria were: (1) pathologically confirmed CC; (2) FIGO stage IB-IIA according to the result of physical examination and imaging; (3) abdominal MRI was performed within three weeks before surgery. Exclusion criteria were: (1) accompanied with other tumors. (2) with chronic infectious disease. (3) incomplete clinical data.
  intervention type: Other
  intervention name: no intervention
  description: no intervention
  arm group label: cervical cancer treated with surgery
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Yang Sun, PHD
  phone: +8615959028989
  email: sunyang@fjzlhospital.com
  facility: 
  contact: 
  country: China
  citation: Salvo G, Odetto D, Saez Perrotta MC, Noll F, Perrotta M, Pareja R, Wernicke A, Ramirez PT. Measurement of tumor size in early cervical cancer: an ever-evolving paradigm. Int J Gynecol Cancer. 2020 Aug;30(8):1215-1223. doi: 10.1136/ijgc-2020-001436. Epub 2020 Jul 6.
  PMID: 32636272
  citation: Thomeer MG, Gerestein C, Spronk S, van Doorn HC, van der Ham E, Hunink MG. Clinical examination versus magnetic resonance imaging in the pretreatment staging of cervical carcinoma: systematic review and meta-analysis. Eur Radiol. 2013 Jul;23(7):2005-18. doi: 10.1007/s00330-013-2783-4. Epub 2013 Mar 1.
  PMID: 23455762
  citation: Wagner-Larsen KS, Lura N, Salvesen O, Halle MK, Forsse D, Trovik J, Smit N, Krakstad C, Haldorsen IS. Interobserver agreement and prognostic impact for MRI-based 2018 FIGO staging parameters in uterine cervical cancer. Eur Radiol. 2022 Sep;32(9):6444-6455. doi: 10.1007/s00330-022-08666-x. Epub 2022 Mar 24.
  PMID: 35332408
  responsible party type: Sponsor
  mesh term: Uterine Cervical Neoplasms
  sharing ipd: No