STOP OVarian CAncer; Implementation of the Opportunistic Salpingectomy in the Netherlands (STOPOVCA)

January 25, 2024 updated by: Radboud University Medical Center
The aim of this study is to optimize implementation of the opportunistic salpingectomy throughout the Netherlands.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • 's-Hertogenbosch, Netherlands, 5223 GZ
        • Jeroen Bosch Hospital
      • Amsterdam, Netherlands, 1091 AC
        • OLVG
      • Amsterdam, Netherlands, 1105AZ
        • Academic Medical Centrum
      • Arnhem, Netherlands, 6800 TA
        • Rijnstate Hospital
      • Breda, Netherlands, 4818 CK
        • Amphia Hospital
      • Delft, Netherlands, 2625 AD
        • Reinier de Graaf
      • Den Haag, Netherlands, 2512 VA
        • Haaglanden Medical Center Westeinde
      • Doetinchem, Netherlands, 7009 BL
        • Slingeland Hospital
      • Dordrecht, Netherlands, 3300 AK
        • Albert Schweitzer Hospital
      • Eindhoven, Netherlands, 5623 EJ
        • Catharina Hospital
      • Enschede, Netherlands, 7500 KA
        • Medical spectrum Twente
      • Groningen, Netherlands, 9728 NT
        • Martini Hospital
      • Haarlem, Netherlands, 2000 AK
        • Spaarne Gasthuis
      • Hengelo, Netherlands, 7555 DL
        • Ziekenhuisgroep Twente
      • Leeuwarden, Netherlands, 8934 AD
        • Medical Center Leewarden
      • Leiden, Netherlands, 2300 RC
        • Leids University Medical Center
      • Maastricht, Netherlands, 6229 HX
        • Maastricht University Medical Center
      • Nieuwegein, Netherlands, 3434 CM
        • St Antonius
      • Nijmegen, Netherlands, 6525 GA
        • Radboud UMC
      • Nijmegen, Netherlands, 6532 SZ
        • Canisius Wilhelmina Hospital
      • Rotterdam, Netherlands, 3000 CA
        • Erasmus Medical Center
      • Tilburg, Netherlands, 5042 AD
        • Elisabeth-TweeSteden Hospital
      • Utrecht, Netherlands, 3508 TG
        • Diakonessenhuis
      • Veldhoven, Netherlands, 5500 MB
        • Maxima Medical Center
      • Venlo, Netherlands, 5801 CE
        • VieCuri Medical Center
      • Weert, Netherlands, 6001 BE
        • Sint Jans Gasthuis
      • Zwolle, Netherlands, 8025 AB
        • Isala

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

26 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Inclusion Criteria:

  • Age from 30 years
  • Undergoing gynaecological surgery in which currently both ovaries and fallopian tubes would be preserved
  • Childbearing completed
  • Able to understand the written or spoken Dutch language
  • Consent for enrolment in database
  • Consent for yearly checks of PALGA database and municipal administration

Exclusion Criteria:

  • Age under 30 years
  • Undergoing surgery without residual ovarian tissue
  • Child wish
  • Unable to understand the written or spoken Dutch language
  • Previous bilateral salpingectomy
  • Previous bilateral salpingo-oophorectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Choice for Opportunistic Salpingectomy
Women who will undergo a gynaecological surgery in which currently both ovaries and fallopian tubes would be preserved, can opt for an opportunistic salpingectomy.
Procedure: Opportunistic Salpingectomy
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Offered Opportunistic Salpingectomy (OS)
Time Frame: 2019 - 2023
Number of eligible women who have actually been offered an opportunistic salpingectomy in the Netherlands.
2019 - 2023
Implementation effect of Opportunistic Salpingectomy (OS)
Time Frame: 2019-2023
The effect of our implementation efforts on the number of eligible women who have actually been offered an opportunistic salpingectomy in the Netherlands.
2019-2023

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Influencing factors implementation Opportunistic Salpingectomy (OS)
Time Frame: 2019-2020
Determine factors that impede and facilitate nationwide implementation of Opportunistic Salpingectomy.
2019-2020
Implementation tools
Time Frame: 2019-2020
Implementation tools, developed based on the barriers and facilitators of the influencing factors.
2019-2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Radboud University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Catharina Ziekenhuis Eindhoven

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joanne A de Hullu, MD, PhD, University Medical Center Nijmegen
  • Principal Investigator: Jurgen MJ Piek, MD, PhD, Catharina Ziekenhuis Eindhoven
  • Principal Investigator: Rosella PM Hermens, PhD, Scietific Institute for Quality of Healthcare, UMC Nijmegen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-1; 11515

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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