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TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention

NCT04294927RecruitingNAINTERVENTIONAL

Summary

The aim of the project is to evaluate the risk-reducing salpingectomy with delayed oophorectomy as an alternative for risk-reducing salpingo-oophorectomy in high risk women with respect to ovarian cancer incidence.

Key Facts

Lead Sponsor

University Medical Center Nijmegen

Enrollment

3000

Start Date

2020-03-01

Completion Date

2040-02-17

Study Type

INTERVENTIONAL

Official Title

TUBectomy With Delayed Oophorectomy as Alternative for Risk-reducing Salpingo-oophorectomy in High Risk Women to Assess the Safety of Prevention: TUBA-WISP II Study.

Interventions

Risk-reducing salpingectomy with delayed oophorectomyRisk-reducing salpingo-oophorectomy

Conditions

BRCA1 Gene MutationBRCA2 Gene MutationRAD51C Gene MutationRAD51D Gene MutationBRIP1 Gene MutationOvarian Cancer

Eligibility

Age Range

25 Years – 50 Years

Sex

FEMALE

Inclusion Criteria:

* Women with a class 5 (definitely pathogenic) BRCA1, BRCA2, RAD51C, RAD51D or BRIP1 germline mutation in one of the participating centers.
* Age at inclusion;

  * BRCA1: 25-40 years
  * BRCA2: 25-45 years
  * RAD51C, RAD51D, BRIP1: 25-50 years
* Childbearing completed
* Presence of at least one fallopian tube
* Participants may have a personal history of non-ovarian malignancy
* Informed consent must be obtained and documented according to national and local regulatory requirements and the local rules followed in the institution.

Exclusion Criteria:

* Postmenopausal status (natural menopause or due to treatment)
* Wish for second stage RRO within two years after RRS
* Legally incapable
* Prior bilateral salpingectomy
* A personal history of ovarian, fallopian tube or peritoneal cancer
* Current diagnosis or treatment for malignant disease

Outcome Measures

Primary Outcomes

High grade serous (ovarian) cancer incidence

Time frame: Until the age of 45 for BRCA1 and 50 for BRCA2 germline mutation carriers

Secondary Outcomes

Incidence of (pre)malignant findings in tubes/ovaries

Incidence of (pre)malignant findings in tubes/ovaries at risk-reducing salpingectomy, oophorectomy and salpingo-oophorectomy.

Time frame: 6 weeks after each surgery

Peri-operative morbidity and mortality

Time frame: 6 weeks after each surgery

Incidence of pelvic cancer (other than ovarian cancer)

Time frame: Up to the age of 70

Incidence of breast cancer

Time frame: Up to the age of 70

Uptake of risk reducing oophorectomy

Uptake of risk reducing oophorectomy after risk reducing salpingectomy

Time frame: Up to the age of 70

Locations

Dana Farber Cancer Institute, Boston, United States

Mayo Clinic, Rochester, United States

MD Anderson Cancer Centre, Houston, United States

University of Washington, Seattle, United States

Chris O'Brien Lifehouse, Sydney, Australia

Westmead hospital, Sydney, Australia

St Andrew War Memorial Hospital, Brisbane, Australia

Royal Brisbane Hospital, Brisbane, Australia

Greenslopes Private Hospital, Brisbane, Australia

Royal Adelaide Hospital, Adelaide, Australia

Frances Perry House, Melbourne, Australia

Mercy Hospital, Melbourne, Australia

Epworth Hospital, Richmon, Australia

Western Health, St Albans, Australia

King Edward Memorial Hospital, Perth, Australia

Monash Health, Melbourne, Australia

Peter MacCallum Centre, Melbourne, Australia

Royal Womens Hospital, Melbourne, Australia

Hopital Universitaire Bruxelles, Brussels, Belgium

Universitair Ziekenhuis Leuven, Leuven, Belgium

AC Camargo Cancer Centre, São Paulo, Brazil

Universita di Bologna, Bologna, Italy

San Gerardo Hospital, Monza, Italy

Gemelli Hospital, Rome, Italy

Instituto Nacional de Cancerología, Mexico City, Mexico

Radboudumc, Nijmegen, Netherlands

Maastricht University Medical Center, Maastricht, Netherlands

Catharina Ziekenhuis, Eindhoven, Netherlands

Elisabeth-TweeSteden Ziekenhuis, Tilburg, Netherlands

Amsterdam University Medical Center, Amsterdam, Netherlands

Antoni van Leeuwenhoek, Amsterdam, Netherlands

Medisch Spectrum Twente, Enschede, Netherlands

University Medical Center Groningen, Groningen, Netherlands

Medical Center Leeuwarden, Leeuwarden, Netherlands

Leiden University Medical Center, Leiden, Netherlands

Erasmus Medical Center, Rotterdam, Netherlands

University Medical Center Utrecht, Utrecht, Netherlands

Maxima Medical Center, Veldhoven, Netherlands

Isala Klinieken, Zwolle, Netherlands

Akershus University Hospital, Nordbyhagen, Norway

Oslo University Hospital, Oslo, Norway

Stavanger Uniersity Hospital, Stavanger, Norway

Gdynia Oncology Centre, Gdynia, Poland

Bonifraterskie Centrum Medyczne, Katowice, Poland

Medical University of Silesia, Katowice, Poland

National Cancer Institute Warsaw, Warsaw, Poland

Karolinksa Institutet, Stockholm, Sweden

Hospital Británico, Montevideo, Uruguay

Linked Papers

2024-11-07

Optimization of Timing for Risk-Reducing Salpingectomy and Oophorectomy

Most cases of ovarian cancer are diagnosed at an advanced stage, and long-term survival rates are low. Because no effective ovarian cancer screening has yet been developed, the primary focus to reduce ovarian cancer mortality is surgical prevention. For individuals with a significantly increased risk of ovarian cancer, risk-reducing bilateral salpingo-oophorectomy is highly effective, but uptake at the recommended age is suboptimal, likely because of concerns about premature menopause. Evidence suggests that many “ovarian” cancers originate in the distal fallopian tube, thus making bilateral salpingectomy after completion of childbearing with delayed oophorectomy an attractive but still unproven risk-reduction option for those who decline or are not yet ready for risk-reducing bilateral salpingo-oophorectomy. Two clinical trials (SOROCk [A Non-randomized Prospective Clinical Trial Comparing the Non-inferiority of Salpingectomy to Salpingo-oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers], NCT04251052; and TUBA-WISP2 [Tubectomy With Delayed Oophorectomy as an Alternative to Risk-Reducing Salpingo-oophorectomy in High-Risk Women to Assess the Safety of Prevention]; NCT04294927) are ongoing to determine whether bilateral salpingectomy with delayed oophorectomy is as effective as risk-reducing bilateral salpingo-oophorectomy to prevent ovarian cancer. The SOROCk trial is a national, prospective nonrandomized trial powered to test the hypothesis that bilateral salpingectomy with delayed oophorectomy is noninferior to risk-reducing bilateral salpingo-oophorectomy to reduce the incidence of ovarian cancer among people with deleterious germline BRCA1 mutations. Gynecologists and gynecologic oncologists in both community-based and academic practices may perform risk-reducing surgeries and have their patients participate in the SOROCk trial. We review key aspects of the SOROCk clinical trial and discuss how surgeons can partner with SOROCk clinical trial sites and facilitate their patients' participation to help answer this important clinical question. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04251052.

2023-06-05

TUBectomy with delayed oophorectomy as an alternative to risk-reducing salpingo-oophorectomy in high-risk women to assess the safety of prevention: the TUBA-WISP II study protocol

Risk-reducing salpingectomy with delayed oophorectomy has gained interest for individuals at high risk for tubo-ovarian cancer as there is compelling evidence that especially high-grade serous carcinoma originates in the fallopian tubes. Two studies have demonstrated a positive effect of salpingectomy on menopause-related quality of life and sexual health compared with standard risk-reducing salpingo-oophorectomy. To investigate whether salpingectomy with delayed oophorectomy is non-inferior to the current standard salpingo-oophorectomy for the prevention of tubo-ovarian cancer among individuals at high inherited risk. We hypothesize that postponement of oophorectomy after salpingectomy, to the age of 40-45 ( In this international prospective preference trial, participants will choose between the novel salpingectomy with delayed oophorectomy and the current standard salpingo-oophorectomy. Salpingectomy can be performed after the completion of childbearing and between the age of 25 and 40 ( Premenopausal individuals with a documented class IV or V germline pathogenic variant in the The primary outcome is the cumulative tubo-ovarian cancer incidence at the target age: 46 years for The sample size to ensure sufficient power to test non-inferiority of salpingectomy with delayed oophorectomy compared with salpingo-oophorectomy requires 1500 Participant recruitment is expected to be completed at the end of 2026 (total recruitment period of 5 years). The primary outcome is expected to be available in 2036 (minimal follow-up period of 10 years). NCT04294927.

Linked Investigators

Majke van Bommel

Miranda P Steenbeek