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

RECRUITING

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.

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Study details:

In BRCA1/2 gene mutation carriers, a risk-reducing salpingo-oophorectomy (RRSO) is recommended around the age of 40. This recommendation is based on a 10-40% life-time risk of ovarian cancer in this population and disappointing results of ovarian cancer surveillance for early detection. Moreover, the mortality rate of ovarian cancer is high.

Effects of RRSO are a decrease in ovarian cancer risk (80-96%) on one hand and immediate onset of menopause and non-cancer related morbidity on the other hand. The fifty percent breast cancer risk reduction after RRSO has become disputable in the last years. Based on multiple studies showing that most high-grade serous ovarian cancers develop at the distal end of the Fallopian tube, an innovative strategy for RRSO has been developed for this study proposal: risk-reducing salpingectomy (RRS) with delayed risk-reducing oophorectomy (RRO).

However, the safety of this strategy has not been proven yet. Before implementing this innovative strategy as standard care we need to investigate the long term effects on ovarian cancer incidence.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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
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    Eligibility

    Age eligible for study : 25 and older

    Healthy volunteers accepted : No

    Gender eligible for study: Female

    Things to know

    Study dates

    Study start: 2020-03-01

    Primary completion: 2040-02-17

    Study completion finish: 2040-02-17

    study type

    Study type

    PREVENTION

    phase

    Phase

      NA

    trial

    Trial ID

    NCT04294927

    Intervention or treatment

    PROCEDURE: Risk-reducing salpingectomy with delayed oophorectomy

    PROCEDURE: Risk-reducing salpingo-oophorectomy

    Conditions

    • Ovarian Cancer
    • BRCA1 Gene Mutation
    • BRCA2 Gene Mutation
    • RAD51C Gene Mutation
    • RAD51D Gene Mutation
    • BRIP1 Gene Mutation
    Image related to Ovarian Cancer
    • Condition: Ovarian Cancer, BRCA1 Gene Mutation and more

    • PROCEDURE: Risk-reducing salpingectomy with delayed oophorectomy and other drugs

    • Melbourne, Not Specified, Australia and more

    • Sponsor: University Medical Center Nijmegen

    Find a site

    Closest Location:

    Monash Health

    Research sites nearby

    Select from list below to view details:

    • Monash Health

      Melbourne, Not Specified, Australia

    • Peter MacCallum Centre

      Melbourne, Not Specified, Australia

    • Royal Womens Hospital

      Melbourne, Not Specified, Australia

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    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?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Risk-reducing salpingectomy with delayed oophorectomy
    • Risk-reducing salpingectomy after the completion of childbearing with delayed oophorectomy.
    PROCEDURE: Risk-reducing salpingectomy with delayed oophorectomy
    • * BRCA1: RRS at age 25-40 and RRO at a maximum age of 45 (advised between 35 and 45).
    • * BRCA2: RRS at age 25-45 and RRO at a maximum age of 50 (advised between age 40 and 50).
    • * BRIP1, RAD51C, RAD51D: RRS at age 25-50 and RRO at a maximum age of 55 (advised between 45 and 55)
    ACTIVE_COMPARATOR: Risk-reducing salpingo-oophorectomy
    • Risk-reducing salpingo-oophorectomy.
    PROCEDURE: Risk-reducing salpingo-oophorectomy
    • * BRCA1 at a maximum age of 40 (advised between age 35 and 40)
    • * BRCA2 at a maximum age of 45 (advised between age 40 and 45)
    • * BRIP1, RAD51C, RAD51D: at a maximum age of 50 (advised between 45 and 50)

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    High grade serous (ovarian) cancer incidenceHigh grade serous (ovarian) cancer incidenceUntil the age of 45 for BRCA1 and 50 for BRCA2 germline mutation carriers

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Incidence of (pre)malignant findings in tubes/ovariesIncidence of (pre)malignant findings in tubes/ovaries at risk-reducing salpingectomy, oophorectomy and salpingo-oophorectomy.6 weeks after each surgery
    Peri-operative morbidity and mortalityPeri-operative morbidity and mortality6 weeks after each surgery
    Incidence of pelvic cancer (other than ovarian cancer)Incidence of pelvic cancer (other than ovarian cancer)Up to the age of 70
    Incidence of breast cancerIncidence of breast cancerUp to the age of 70
    Uptake of risk reducing oophorectomyUptake of risk reducing oophorectomy after risk reducing salpingectomyUp to the age of 70

    Frequently Asked Questions

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    References

    Clinical Trials Gov: TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention

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