<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/NCT04470921</url>
  </required_header>
  <id_info>
    <org_study_id>2018-1; 11515</org_study_id>
    <nct_id>NCT04470921</nct_id>
  </id_info>
  <brief_title>STOP OVarian CAncer; Implementation of the Opportunistic Salpingectomy in the Netherlands</brief_title>
  <acronym>STOPOVCA</acronym>
  <official_title>STOP OVarian CAncer; Implementation of the Opportunistic Salpingectomy in the Netherlands</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Catharina Ziekenhuis Eindhoven</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Radboud University Medical Center</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>
      The aim of this study is to optimize implementation of the opportunistic salpingectomy&#xD;
      throughout the Netherlands.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators aim to optimize implementation of opportunistic salpingectomy throughout&#xD;
      the Netherlands. The investigators will evaluate the implementation by enrolling patients in&#xD;
      a database to evaluate healthcare experiences and to register EOC diagnosis and vital status&#xD;
      through yearly PALGA (the nationwide network and registry of histopathology and cytopathology&#xD;
      in the Netherlands) and municipal administration searches. In addition, the investigators&#xD;
      will perform medical record check to assess which percentage of eligible women have been&#xD;
      offered OS.&#xD;
&#xD;
      The investigators expect that a decision aid will be a necessary tool for the decision&#xD;
      whether women opt for an OS or not, based on their personal values. After development of the&#xD;
      tool(s), the investigators will evaluate the implementation process.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2050</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2023</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>Offered Opportunistic Salpingectomy (OS)</measure>
    <time_frame>2019 - 2023</time_frame>
    <description>Number of eligible women who have actually been offered an opportunistic salpingectomy in the Netherlands.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Implementation effect of Opportunistic Salpingectomy (OS)</measure>
    <time_frame>2019-2023</time_frame>
    <description>The effect of our implementation efforts on the number of eligible women who have actually been offered an opportunistic salpingectomy in the Netherlands.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Influencing factors implementation Opportunistic Salpingectomy (OS)</measure>
    <time_frame>2019-2020</time_frame>
    <description>Determine factors that impede and facilitate nationwide implementation of Opportunistic Salpingectomy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implementation tools</measure>
    <time_frame>2019-2020</time_frame>
    <description>Implementation tools, developed based on the barriers and facilitators of the influencing factors.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Risk Reduction</condition>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>Choice for Opportunistic Salpingectomy</arm_group_label>
    <description>Women who will undergo a gynaecological surgery in which currently both ovaries and fallopian tubes would be preserved, can opt for an opportunistic salpingectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Opportunistic Salpingectomy</intervention_name>
    <description>An opportunistic salpingectomy refers to removal of the fallopian tubes without the ovaries during (laparoscopic) interventions for benign (gynaecological) disease to reduce the number of ovarian cancer cases.</description>
    <arm_group_label>Choice for Opportunistic Salpingectomy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women who will undergo a gynaecological surgery in which currently both ovaries and&#xD;
        fallopian tubes would be preserved, can opt for an opportunistic salpingectomy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age from 30 years&#xD;
&#xD;
          -  Undergoing gynaecological surgery in which currently both ovaries and fallopian tubes&#xD;
             would be preserved&#xD;
&#xD;
          -  Childbearing completed&#xD;
&#xD;
          -  Able to understand the written or spoken Dutch language&#xD;
&#xD;
          -  Consent for enrolment in database&#xD;
&#xD;
          -  Consent for yearly checks of PALGA database and municipal administration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age under 30 years&#xD;
&#xD;
          -  Undergoing surgery without residual ovarian tissue&#xD;
&#xD;
          -  Child wish&#xD;
&#xD;
          -  Unable to understand the written or spoken Dutch language&#xD;
&#xD;
          -  Previous bilateral salpingectomy&#xD;
&#xD;
          -  Previous bilateral salpingo-oophorectomy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joanne A de Hullu, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medical Center Nijmegen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jurgen MJ Piek, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Catharina Ziekenhuis Eindhoven</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rosella PM Hermens, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Scietific Institute for Quality of Healthcare, UMC Nijmegen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jeroen Bosch Hospital</name>
      <address>
        <city>'s-Hertogenbosch</city>
        <zip>5223 GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OLVG</name>
      <address>
        <city>Amsterdam</city>
        <zip>1091 AC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academic Medical Centrum</name>
      <address>
        <city>Amsterdam</city>
        <zip>1105AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rijnstate Hospital</name>
      <address>
        <city>Arnhem</city>
        <zip>6800 TA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amphia hospital</name>
      <address>
        <city>Breda</city>
        <zip>4818 CK</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reinier de Graaf</name>
      <address>
        <city>Delft</city>
        <zip>2625 AD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haaglanden Medical Center Westeinde</name>
      <address>
        <city>Den Haag</city>
        <zip>2512 VA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Slingeland Hospital</name>
      <address>
        <city>Doetinchem</city>
        <zip>7009 BL</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albert Schweitzer hospital</name>
      <address>
        <city>Dordrecht</city>
        <zip>3300 AK</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Catharina Hospital</name>
      <address>
        <city>Eindhoven</city>
        <zip>5623 EJ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Spectrum Twente</name>
      <address>
        <city>Enschede</city>
        <zip>7500 KA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Martini hospital</name>
      <address>
        <city>Groningen</city>
        <zip>9728 NT</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spaarne Gasthuis</name>
      <address>
        <city>Haarlem</city>
        <zip>2000 AK</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ziekenhuisgroep Twente</name>
      <address>
        <city>Hengelo</city>
        <zip>7555 DL</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Leewarden</name>
      <address>
        <city>Leeuwarden</city>
        <zip>8934 AD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leids University Medical Center</name>
      <address>
        <city>Leiden</city>
        <zip>2300 RC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maastricht University Medical Center</name>
      <address>
        <city>Maastricht</city>
        <zip>6229 HX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Antonius</name>
      <address>
        <city>Nieuwegein</city>
        <zip>3434 CM</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radboud UMC</name>
      <address>
        <city>Nijmegen</city>
        <zip>6525 GA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Canisius Wilhelmina Hospital</name>
      <address>
        <city>Nijmegen</city>
        <zip>6532 SZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus Medical Center</name>
      <address>
        <city>Rotterdam</city>
        <zip>3000 CA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elisabeth-Tweesteden Hospital</name>
      <address>
        <city>Tilburg</city>
        <zip>5042 AD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diakonessenhuis</name>
      <address>
        <city>Utrecht</city>
        <zip>3508 TG</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maxima Medical Center</name>
      <address>
        <city>Veldhoven</city>
        <zip>5500 MB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VieCuri Medical Center</name>
      <address>
        <city>Venlo</city>
        <zip>5801 CE</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sint Jans Gasthuis</name>
      <address>
        <city>Weert</city>
        <zip>6001 BE</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Isala</name>
      <address>
        <city>Zwolle</city>
        <zip>8025 AB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>Yoon SH, Kim SN, Shim SH, Kang SB, Lee SJ. Bilateral salpingectomy can reduce the risk of ovarian cancer in the general population: A meta-analysis. Eur J Cancer. 2016 Mar;55:38-46. doi: 10.1016/j.ejca.2015.12.003. Epub 2016 Jan 8.</citation>
    <PMID>26773418</PMID>
  </reference>
  <reference>
    <citation>Kwon JS, McAlpine JN, Hanley GE, Finlayson SJ, Cohen T, Miller DM, Gilks CB, Huntsman DG. Costs and benefits of opportunistic salpingectomy as an ovarian cancer prevention strategy. Obstet Gynecol. 2015 Feb;125(2):338-345. doi: 10.1097/AOG.0000000000000630.</citation>
    <PMID>25568991</PMID>
  </reference>
  <reference>
    <citation>van Lieshout LAM, Steenbeek MP, De Hullu JA, Vos MC, Houterman S, Wilkinson J, Piek JM. Hysterectomy with opportunistic salpingectomy versus hysterectomy alone. Cochrane Database Syst Rev. 2019 Aug 28;8(8):CD012858. doi: 10.1002/14651858.CD012858.pub2.</citation>
    <PMID>31456223</PMID>
  </reference>
  <reference>
    <citation>Steenbeek MP, van Lieshout LAM, Aarts JWM, Piek JMJ, Coppus SFPJ, Massuger LFAG, Hermens RPMG, de Hullu JA. Factors influencing decision-making around opportunistic salpingectomy: a nationwide survey. J Gynecol Oncol. 2019 Jan;30(1):e2. doi: 10.3802/jgo.2019.30.e2. Epub 2018 Apr 30.</citation>
    <PMID>30479086</PMID>
  </reference>
  <reference>
    <citation>Committee opinion no. 620: Salpingectomy for ovarian cancer prevention. Obstet Gynecol. 2015 Jan;125(1):279-281. doi: 10.1097/01.AOG.0000459871.88564.09. Erratum In: Obstet Gynecol. 2016 Feb;127(2):405. Obstet Gynecol. 2016 Feb;127(2):405.</citation>
    <PMID>25560145</PMID>
  </reference>
  <reference>
    <citation>Salvador S, Scott S, Francis JA, Agrawal A, Giede C. No. 344-Opportunistic Salpingectomy and Other Methods of Risk Reduction for Ovarian/Fallopian Tube/Peritoneal Cancer in the General Population. J Obstet Gynaecol Can. 2017 Jun;39(6):480-493. doi: 10.1016/j.jogc.2016.12.005.</citation>
    <PMID>28527613</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>November 8, 2022</last_update_submitted>
  <last_update_submitted_qc>November 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ovarian cancer</keyword>
  <keyword>Opportunistic Salpingectomy</keyword>
  <keyword>Prevention</keyword>
  <keyword>Female sterilization</keyword>
  <keyword>Risk reduction</keyword>
  <keyword>Implementation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</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/NCT04470921
org study id: 2018-1; 11515
nct id: NCT04470921
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to optimize implementation of the opportunistic salpingectomy
      throughout the Netherlands.
The investigators aim to optimize implementation of opportunistic salpingectomy throughout
      the Netherlands. The investigators will evaluate the implementation by enrolling patients in
      a database to evaluate healthcare experiences and to register EOC diagnosis and vital status
      through yearly PALGA (the nationwide network and registry of histopathology and cytopathology
      in the Netherlands) and municipal administration searches. In addition, the investigators
      will perform medical record check to assess which percentage of eligible women have been
      offered OS.

      The investigators expect that a decision aid will be a necessary tool for the decision
      whether women opt for an OS or not, based on their personal values. After development of the
      tool(s), the investigators will evaluate the implementation process.
observational model: Cohort
time perspective: Prospective
measure: Offered Opportunistic Salpingectomy (OS)
time frame: 2019 - 2023
description: Number of eligible women who have actually been offered an opportunistic salpingectomy in the Netherlands.
measure: Implementation effect of Opportunistic Salpingectomy (OS)
time frame: 2019-2023
description: The effect of our implementation efforts on the number of eligible women who have actually been offered an opportunistic salpingectomy in the Netherlands.
measure: Influencing factors implementation Opportunistic Salpingectomy (OS)
time frame: 2019-2020
description: Determine factors that impede and facilitate nationwide implementation of Opportunistic Salpingectomy.
measure: Implementation tools
time frame: 2019-2020
description: Implementation tools, developed based on the barriers and facilitators of the influencing factors.
arm group label: Choice for Opportunistic Salpingectomy
description: Women who will undergo a gynaecological surgery in which currently both ovaries and fallopian tubes would be preserved, can opt for an opportunistic salpingectomy.
intervention type: Procedure
intervention name: Opportunistic Salpingectomy
description: An opportunistic salpingectomy refers to removal of the fallopian tubes without the ovaries during (laparoscopic) interventions for benign (gynaecological) disease to reduce the number of ovarian cancer cases.
arm group label: Choice for Opportunistic Salpingectomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
last name: Joanne A de Hullu, MD, PhD
role: Principal Investigator
affiliation: University Medical Center Nijmegen
last name: Jurgen MJ Piek, MD, PhD
role: Principal Investigator
affiliation: Catharina Ziekenhuis Eindhoven
last name: Rosella PM Hermens, PhD
role: Principal Investigator
affiliation: Scietific Institute for Quality of Healthcare, UMC Nijmegen
facility: 
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country: Netherlands
citation: Yoon SH, Kim SN, Shim SH, Kang SB, Lee SJ. Bilateral salpingectomy can reduce the risk of ovarian cancer in the general population: A meta-analysis. Eur J Cancer. 2016 Mar;55:38-46. doi: 10.1016/j.ejca.2015.12.003. Epub 2016 Jan 8.
PMID: 26773418
citation: Kwon JS, McAlpine JN, Hanley GE, Finlayson SJ, Cohen T, Miller DM, Gilks CB, Huntsman DG. Costs and benefits of opportunistic salpingectomy as an ovarian cancer prevention strategy. Obstet Gynecol. 2015 Feb;125(2):338-345. doi: 10.1097/AOG.0000000000000630.
PMID: 25568991
citation: van Lieshout LAM, Steenbeek MP, De Hullu JA, Vos MC, Houterman S, Wilkinson J, Piek JM. Hysterectomy with opportunistic salpingectomy versus hysterectomy alone. Cochrane Database Syst Rev. 2019 Aug 28;8(8):CD012858. doi: 10.1002/14651858.CD012858.pub2.
PMID: 31456223
citation: Steenbeek MP, van Lieshout LAM, Aarts JWM, Piek JMJ, Coppus SFPJ, Massuger LFAG, Hermens RPMG, de Hullu JA. Factors influencing decision-making around opportunistic salpingectomy: a nationwide survey. J Gynecol Oncol. 2019 Jan;30(1):e2. doi: 10.3802/jgo.2019.30.e2. Epub 2018 Apr 30.
PMID: 30479086
citation: Committee opinion no. 620: Salpingectomy for ovarian cancer prevention. Obstet Gynecol. 2015 Jan;125(1):279-281. doi: 10.1097/01.AOG.0000459871.88564.09. Erratum In: Obstet Gynecol. 2016 Feb;127(2):405. Obstet Gynecol. 2016 Feb;127(2):405.
PMID: 25560145
citation: Salvador S, Scott S, Francis JA, Agrawal A, Giede C. No. 344-Opportunistic Salpingectomy and Other Methods of Risk Reduction for Ovarian/Fallopian Tube/Peritoneal Cancer in the General Population. J Obstet Gynaecol Can. 2017 Jun;39(6):480-493. doi: 10.1016/j.jogc.2016.12.005.
PMID: 28527613
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
sharing ipd: Undecided