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/NCT06007625</url>
    </required_header>
    <id_info>
      <org_study_id>MCOG-VC01</org_study_id>
      <nct_id>NCT06007625</nct_id>
    </id_info>
    <brief_title>Vulvar Cancer Individualized Scoring System (VCISS)</brief_title>
    <official_title>Vulvar Cancer Individualized Scoring System</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</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 machine learning-based prediction model for patients with vulvar&#xD;
        cancer. This model will utilize patient characteristics and disease features to determine the&#xD;
        disease's prognosis. The scoring system will also include management information to&#xD;
        facilitate prediction of clinical outcomes of different management strategies and potential&#xD;
        management that would yield the best prognosis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Vulvar cancer (VC) is a relatively rare gynecological cancer accounting for 5-8% of all cases&#xD;
        [1].&#xD;
  &#xD;
        It comes the fourth among the commonest gynecological cancers and tends to affect women after&#xD;
        menopause with a median age of 68 years [2,3].&#xD;
  &#xD;
        Risk factors include cervical intraepithelial neoplasia, prior history of cervical cancer,&#xD;
        smoking, lichen sclerosus, and immunodeficiency syndromes [4-5]. As squamous cell carcinoma&#xD;
        is considered the most common type of VC, there are two potential pathogenic pathways for&#xD;
        squamous cell carcinoma of the vulva include chronic inflammatory processes and human&#xD;
        papillomavirus (HPV) infection [6-7].&#xD;
  &#xD;
        While VC may be asymptomatic, most cases are present with bleeding, discharge, vulvar mass,&#xD;
        ulcer and/or pruritis. Furthermore, it can be presented by a groin mass which reflects&#xD;
        inguinal lymph node involvement. VC may be confined to the primary site in 59% of cases while&#xD;
        30% and 6% of cases spread to regional lymph nodes and distant areas, respectively [8].&#xD;
  &#xD;
        FIGO staging is considered the standard classification system that determines prognosis and&#xD;
        management of newly diagnosed VC. However, there are numerous gaps in the current staging&#xD;
        system that would limit full interpretation of prognosis and management guidance [9].&#xD;
        Although staging system primarily determines disease prognosis, the staging system does not&#xD;
        consider all prognostic factors, such as disease stage and histopathology. In fact, factors&#xD;
        other than lymph node metastasis may have a stronger predictive influence such as the&#xD;
        severity of the disease, age, histologic type and adjuvant radiotherapy and chemotherapy&#xD;
        [10].&#xD;
  &#xD;
        Development of a prognostic and decision-making system, based on comprehensive inclusion of&#xD;
        individual patient and disease characteristics, would facilitate accurate prediction of&#xD;
        disease prognosis and determination of individualized management strategy&#xD;
  &#xD;
        A retrospective multicenter cohort study will be conducted among at least 6 European&#xD;
        gynecologic oncology centers.&#xD;
  &#xD;
        Inclusion Criteria:&#xD;
  &#xD;
          1. Women diagnosed with Vulvar cancer and treated at collaborating centers between January&#xD;
             1st, 2008, and December 31st, 2017.&#xD;
  &#xD;
          2. Women aged 18 years old or older, complete follow-up on for at least 3 years, unless&#xD;
             censored by mortality.&#xD;
  &#xD;
        Exclusion criteria:&#xD;
  &#xD;
          1. Women will be excluded from the study if there were lost to follow-up before 3 years&#xD;
             post-treatment.&#xD;
  &#xD;
          2. If the patient did not not receive their treatment in the receptive centers, and if they&#xD;
             were diagnosed with synchronous cancers.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">December 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2024</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>cancer-specific survival (CSS) rate at 3 and 5 years</measure>
      <time_frame>at 3 and 5 years</time_frame>
      <description>Primary outcome of the study will be cancer-specific survival (CSS) rate at 3 and 5 years after initiation of treatment.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Recurrence-free survival (RFS) rate at 3 and 5 years</measure>
      <time_frame>at 3 and 5 years</time_frame>
      <description>Recurrence-free survival (RFS) rate at 3 and 5 years constitutes secondary outcomes</description>
    </secondary_outcome>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Vulvar Cancer</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Machine learning-based prediction model</intervention_name>
      <description>This model will utilize patient characteristics and disease features to determine the disease's prognosis. The scoring system will also include management information to facilitate prediction of clinical outcomes of different management strategies and potential management that would yield the best prognosis.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All women who will be diagnosed with primary vulvar cancer at any stage, of all&#xD;
          histological types and grades eligible for the study&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women diagnosed with Vulvar cancer and treated at collaborating centers between&#xD;
               January 1st, 2008, and December 31st, 2017&#xD;
  &#xD;
            -  women aged 18 years old or older, complete follow-up on for at least 3 years, unless&#xD;
               censored by mortality.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Women will be excluded from the study if there were lost to follow-up before 3 years&#xD;
               post-treatment&#xD;
  &#xD;
            -  If the patient did not receive their treatment in the receptive centers&#xD;
  &#xD;
            -  If the patient were diagnosed with synchronous cancers&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Sherif Shazly</last_name>
      <phone>+4407554480388</phone>
      <email>sherif.shazly.mogge@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Alexandria University Main Hospital</name>
        <address>
          <city>Alexandria</city>
          <zip>21516</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <contact>
        <last_name>Ahmed H. Ismail</last_name>
        <phone>01144557597</phone>
        <email>ahmed.ismail.mogge@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Assiut Hospitals university</name>
        <address>
          <city>Assiut</city>
          <zip>71511</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <contact>
        <last_name>Manar M, Ahmed</last_name>
        <phone>01128793950</phone>
        <email>Manar.mahran.mogge@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Shetty AS, Menias CO. MR Imaging of Vulvar and Vaginal Cancer. Magn Reson Imaging Clin N Am. 2017 Aug;25(3):481-502. doi: 10.1016/j.mric.2017.03.013. Epub 2017 May 27.</citation>
      <PMID>28668156</PMID>
    </reference>
    <reference>
      <citation>Chow L, Tsui BQ, Bahrami S, Masamed R, Memarzadeh S, Raman SS, Patel MK. Gynecologic tumor board: a radiologist's guide to vulvar and vaginal malignancies. Abdom Radiol (NY). 2021 Dec;46(12):5669-5686. doi: 10.1007/s00261-021-03209-2. Epub 2021 Aug 25.</citation>
      <PMID>34435227</PMID>
    </reference>
    <reference>
      <citation>Merlo S. Modern treatment of vulvar cancer. Radiol Oncol. 2020 Sep 22;54(4):371-376. doi: 10.2478/raon-2020-0053.</citation>
      <PMID>32960779</PMID>
    </reference>
    <reference>
      <citation>Madsen BS, Jensen HL, van den Brule AJ, Wohlfahrt J, Frisch M. Risk factors for invasive squamous cell carcinoma of the vulva and vagina--population-based case-control study in Denmark. Int J Cancer. 2008 Jun 15;122(12):2827-34. doi: 10.1002/ijc.23446.</citation>
      <PMID>18348142</PMID>
    </reference>
    <reference>
      <citation>Brinton LA, Thistle JE, Liao LM, Trabert B. Epidemiology of vulvar neoplasia in the NIH-AARP Study. Gynecol Oncol. 2017 May;145(2):298-304. doi: 10.1016/j.ygyno.2017.02.030. Epub 2017 Feb 22.</citation>
      <PMID>28236455</PMID>
    </reference>
    <reference>
      <citation>de Koning MN, Quint WG, Pirog EC. Prevalence of mucosal and cutaneous human papillomaviruses in different histologic subtypes of vulvar carcinoma. Mod Pathol. 2008 Mar;21(3):334-44. doi: 10.1038/modpathol.3801009. Epub 2008 Jan 11.</citation>
      <PMID>18192968</PMID>
    </reference>
    <reference>
      <citation>Halec G, Alemany L, Quiros B, Clavero O, Hofler D, Alejo M, Quint W, Pawlita M, Bosch FX, de Sanjose S. Biological relevance of human papillomaviruses in vulvar cancer. Mod Pathol. 2017 Apr;30(4):549-562. doi: 10.1038/modpathol.2016.197. Epub 2017 Jan 6.</citation>
      <PMID>28059099</PMID>
    </reference>
    <reference>
      <citation>Virarkar M, Vulasala SS, Daoud T, Javadi S, Lall C, Bhosale P. Vulvar Cancer: 2021 Revised FIGO Staging System and the Role of Imaging. Cancers (Basel). 2022 Apr 30;14(9):2264. doi: 10.3390/cancers14092264.</citation>
      <PMID>35565394</PMID>
    </reference>
    <reference>
      <citation>Salvo G, Odetto D, Pareja R, Frumovitz M, Ramirez PT. Revised 2018 International Federation of Gynecology and Obstetrics (FIGO) cervical cancer staging: A review of gaps and questions that remain. Int J Gynecol Cancer. 2020 Jun;30(6):873-878. doi: 10.1136/ijgc-2020-001257. Epub 2020 Apr 1.</citation>
      <PMID>32241876</PMID>
    </reference>
    <reference>
      <citation>Miljanovic-Spika I, Madunic MD, Topolovec Z, Kujadin Kenjeres D, Vidosavljevic D. PROGNOSTIC FACTORS FOR VULVAR CANCER. Acta Clin Croat. 2021 Mar;60(1):25-32. doi: 10.20471/acc.2021.60.01.04.</citation>
      <PMID>34588718</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Middle-Eastern College of Obstetricians and Gynecologists</investigator_affiliation>
      <investigator_full_name>Sherif Abdelkarim Mohammed Shazly</investigator_full_name>
      <investigator_title>Sherif Abdelkarim Mohammed Shazly, Assistant lecturer, Assiut University</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vulvar Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06007625
  org study id: MCOG-VC01
  nct id: NCT06007625
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to develop a machine learning-based prediction model for patients with vulvar
        cancer. This model will utilize patient characteristics and disease features to determine the
        disease's prognosis. The scoring system will also include management information to
        facilitate prediction of clinical outcomes of different management strategies and potential
        management that would yield the best prognosis.
  Vulvar cancer (VC) is a relatively rare gynecological cancer accounting for 5-8% of all cases
        [1].
  
        It comes the fourth among the commonest gynecological cancers and tends to affect women after
        menopause with a median age of 68 years [2,3].
  
        Risk factors include cervical intraepithelial neoplasia, prior history of cervical cancer,
        smoking, lichen sclerosus, and immunodeficiency syndromes [4-5]. As squamous cell carcinoma
        is considered the most common type of VC, there are two potential pathogenic pathways for
        squamous cell carcinoma of the vulva include chronic inflammatory processes and human
        papillomavirus (HPV) infection [6-7].
  
        While VC may be asymptomatic, most cases are present with bleeding, discharge, vulvar mass,
        ulcer and/or pruritis. Furthermore, it can be presented by a groin mass which reflects
        inguinal lymph node involvement. VC may be confined to the primary site in 59% of cases while
        30% and 6% of cases spread to regional lymph nodes and distant areas, respectively [8].
  
        FIGO staging is considered the standard classification system that determines prognosis and
        management of newly diagnosed VC. However, there are numerous gaps in the current staging
        system that would limit full interpretation of prognosis and management guidance [9].
        Although staging system primarily determines disease prognosis, the staging system does not
        consider all prognostic factors, such as disease stage and histopathology. In fact, factors
        other than lymph node metastasis may have a stronger predictive influence such as the
        severity of the disease, age, histologic type and adjuvant radiotherapy and chemotherapy
        [10].
  
        Development of a prognostic and decision-making system, based on comprehensive inclusion of
        individual patient and disease characteristics, would facilitate accurate prediction of
        disease prognosis and determination of individualized management strategy
  
        A retrospective multicenter cohort study will be conducted among at least 6 European
        gynecologic oncology centers.
  
        Inclusion Criteria:
  
          1. Women diagnosed with Vulvar cancer and treated at collaborating centers between January
             1st, 2008, and December 31st, 2017.
  
          2. Women aged 18 years old or older, complete follow-up on for at least 3 years, unless
             censored by mortality.
  
        Exclusion criteria:
  
          1. Women will be excluded from the study if there were lost to follow-up before 3 years
             post-treatment.
  
          2. If the patient did not not receive their treatment in the receptive centers, and if they
             were diagnosed with synchronous cancers.
  observational model: Cohort
  time perspective: Retrospective
  measure: cancer-specific survival (CSS) rate at 3 and 5 years
  time frame: at 3 and 5 years
  description: Primary outcome of the study will be cancer-specific survival (CSS) rate at 3 and 5 years after initiation of treatment.
  measure: Recurrence-free survival (RFS) rate at 3 and 5 years
  time frame: at 3 and 5 years
  description: Recurrence-free survival (RFS) rate at 3 and 5 years constitutes secondary outcomes
  intervention type: Other
  intervention name: Machine learning-based prediction model
  description: This model will utilize patient characteristics and disease features to determine the disease's prognosis. The scoring system will also include management information to facilitate prediction of clinical outcomes of different management strategies and potential management that would yield the best prognosis.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sherif Shazly
  phone: +4407554480388
  email: sherif.shazly.mogge@gmail.com
  facility: 
  contact: 
  facility: 
  contact: 
  country: Egypt
  citation: Shetty AS, Menias CO. MR Imaging of Vulvar and Vaginal Cancer. Magn Reson Imaging Clin N Am. 2017 Aug;25(3):481-502. doi: 10.1016/j.mric.2017.03.013. Epub 2017 May 27.
  PMID: 28668156
  citation: Chow L, Tsui BQ, Bahrami S, Masamed R, Memarzadeh S, Raman SS, Patel MK. Gynecologic tumor board: a radiologist's guide to vulvar and vaginal malignancies. Abdom Radiol (NY). 2021 Dec;46(12):5669-5686. doi: 10.1007/s00261-021-03209-2. Epub 2021 Aug 25.
  PMID: 34435227
  citation: Merlo S. Modern treatment of vulvar cancer. Radiol Oncol. 2020 Sep 22;54(4):371-376. doi: 10.2478/raon-2020-0053.
  PMID: 32960779
  citation: Madsen BS, Jensen HL, van den Brule AJ, Wohlfahrt J, Frisch M. Risk factors for invasive squamous cell carcinoma of the vulva and vagina--population-based case-control study in Denmark. Int J Cancer. 2008 Jun 15;122(12):2827-34. doi: 10.1002/ijc.23446.
  PMID: 18348142
  citation: Brinton LA, Thistle JE, Liao LM, Trabert B. Epidemiology of vulvar neoplasia in the NIH-AARP Study. Gynecol Oncol. 2017 May;145(2):298-304. doi: 10.1016/j.ygyno.2017.02.030. Epub 2017 Feb 22.
  PMID: 28236455
  citation: de Koning MN, Quint WG, Pirog EC. Prevalence of mucosal and cutaneous human papillomaviruses in different histologic subtypes of vulvar carcinoma. Mod Pathol. 2008 Mar;21(3):334-44. doi: 10.1038/modpathol.3801009. Epub 2008 Jan 11.
  PMID: 18192968
  citation: Halec G, Alemany L, Quiros B, Clavero O, Hofler D, Alejo M, Quint W, Pawlita M, Bosch FX, de Sanjose S. Biological relevance of human papillomaviruses in vulvar cancer. Mod Pathol. 2017 Apr;30(4):549-562. doi: 10.1038/modpathol.2016.197. Epub 2017 Jan 6.
  PMID: 28059099
  citation: Virarkar M, Vulasala SS, Daoud T, Javadi S, Lall C, Bhosale P. Vulvar Cancer: 2021 Revised FIGO Staging System and the Role of Imaging. Cancers (Basel). 2022 Apr 30;14(9):2264. doi: 10.3390/cancers14092264.
  PMID: 35565394
  citation: Salvo G, Odetto D, Pareja R, Frumovitz M, Ramirez PT. Revised 2018 International Federation of Gynecology and Obstetrics (FIGO) cervical cancer staging: A review of gaps and questions that remain. Int J Gynecol Cancer. 2020 Jun;30(6):873-878. doi: 10.1136/ijgc-2020-001257. Epub 2020 Apr 1.
  PMID: 32241876
  citation: Miljanovic-Spika I, Madunic MD, Topolovec Z, Kujadin Kenjeres D, Vidosavljevic D. PROGNOSTIC FACTORS FOR VULVAR CANCER. Acta Clin Croat. 2021 Mar;60(1):25-32. doi: 10.20471/acc.2021.60.01.04.
  PMID: 34588718
  responsible party type: Principal Investigator
  investigator affiliation: Middle-Eastern College of Obstetricians and Gynecologists
  investigator full name: Sherif Abdelkarim Mohammed Shazly
  investigator title: Sherif Abdelkarim Mohammed Shazly, Assistant lecturer, Assiut University
  mesh term: Vulvar Neoplasms
  sharing ipd: Undecided