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Risk ReductionSTOPOVCANCT04470921

STOP OVarian CAncer; Implementation of the Opportunistic Salpingectomy in the Netherlands

An observational study of Risk Reduction and Ovarian Cancer, run by Radboud University Medical Center at 27 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to optimize implementation of the opportunistic salpingectomy throughout the Netherlands. Read more about this study

Who is it for?
Ages 30 years and older, women only
Conditions the study is for
Risk Reduction, Ovarian Cancer
What is being tested?
Opportunistic Salpingectomy
Type of treatment
Surgery or procedure
How many people
10,000 participants
Where
27 sitesNetherlands
Study dates
1 Jan 2019to 31 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

Netherlands27 sites

  • Jeroen Bosch Hospital

    's-Hertogenbosch, 5223 GZ

  • OLVG

    Amsterdam, 1091 AC

  • Academic Medical Centrum

    Amsterdam, 1105AZ

  • Rijnstate Hospital

    Arnhem, 6800 TA

  • Amphia hospital

    Breda, 4818 CK

  • Reinier de Graaf

    Delft, 2625 AD

  • Slingeland Hospital

    Doetinchem, 7009 BL

  • Albert Schweitzer hospital

    Dordrecht, 3300 AK

  • Catharina Hospital

    Eindhoven, 5623 EJ

  • Medical Spectrum Twente

    Enschede, 7500 KA

  • Martini hospital

    Groningen, 9728 NT

  • Spaarne Gasthuis

    Haarlem, 2000 AK

  • Ziekenhuisgroep Twente

    Hengelo, 7555 DL

  • Medical Center Leewarden

    Leeuwarden, 8934 AD

  • Leids University Medical Center

    Leiden, 2300 RC

  • Maastricht University Medical Center

    Maastricht, 6229 HX

  • St Antonius

    Nieuwegein, 3434 CM

  • Radboud UMC

    Nijmegen, 6525 GA

  • Canisius Wilhelmina Hospital

    Nijmegen, 6532 SZ

  • Erasmus Medical Center

    Rotterdam, 3000 CA

  • Haaglanden Medical Center Westeinde

    The Hague, 2512 VA

  • Elisabeth-Tweesteden Hospital

    Tilburg, 5042 AD

  • Diakonessenhuis

    Utrecht, 3508 TG

  • Maxima Medical Center

    Veldhoven, 5500 MB

  • VieCuri Medical Center

    Venlo, 5801 CE

  • Sint Jans Gasthuis

    Weert, 6001 BE

  • Isala

    Zwolle, 8025 AB

Other trials in Netherlands

About this study

The aim of this study is to optimize implementation of the opportunistic salpingectomy throughout the Netherlands.

Read the 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.

Being tested
Opportunistic Salpingectomy
Keywords
Ovarian cancer, Opportunistic Salpingectomy, Prevention, Female sterilization, Risk reduction, Implementation
Medical subject headings
Risk Reduction Behavior, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Opportunistic SalpingectomyProcedure or surgery

    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.

Study groups in NCT04470921
Study groupRoleWhat they receive
Choice for Opportunistic SalpingectomyWomen who will undergo a gynaecological surgery in which currently both ovaries and fallopian tubes would be preserved, can opt for an opportunistic salpingectomy.
Receives: Procedure: Opportunistic Salpingectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Offered Opportunistic Salpingectomy (OS)

    Number of eligible women who have actually been offered an opportunistic salpingectomy in the Netherlands.

    Measured: 2019 - 2023

  2. Implementation effect of Opportunistic Salpingectomy (OS)

    The effect of our implementation efforts on the number of eligible women who have actually been offered an opportunistic salpingectomy in the Netherlands.

    Measured: 2019-2023

Secondary outcomes (2)

  1. Influencing factors implementation Opportunistic Salpingectomy (OS)

    Determine factors that impede and facilitate nationwide implementation of Opportunistic Salpingectomy.

    Measured: 2019-2020

  2. Implementation tools

    Implementation tools, developed based on the barriers and facilitators of the influencing factors.

    Measured: 2019-2020

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2020
  2. Study start1 Jan 2019
  3. Primary completion1 Jan 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04470921
Sponsor's protocol ID
2018-1; 11515
Acronym
STOPOVCA
Status last verified
Jan 2024
First submitted
9 Jul 2020
Last updated
26 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 26773418

  • 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.

    PubMed 25568991

  • 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.

    PubMed 31456223

  • 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.

    PubMed 30479086

  • 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.

    PubMed 25560145

  • 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.

    PubMed 28527613

Questions about this trial

What is this clinical trial studying?

An observational study of Risk Reduction and Ovarian Cancer, run by Radboud University Medical Center at 27 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Offered Opportunistic Salpingectomy (OS) (time frame: 2019 - 2023). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04470921, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.

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