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

Description

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.

Conditions

BRCA1 Gene Mutation, BRCA2 Gene Mutation, RAD51C Gene Mutation, RAD51D Gene Mutation, BRIP1 Gene Mutation, Ovarian Cancer

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Study Overview

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Study Details

Study overview

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.

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.

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

Condition
BRCA1 Gene Mutation
Intervention / Treatment

-

Contacts and Locations

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Houston

MD Anderson Cancer Centre, Houston, Texas, United States, 77030-4009

Seattle

University of Washington, Seattle, Washington, United States, 98195

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

25 Years to 50 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University Medical Center Nijmegen,

Joanne A. de Hullu, MD, PhD, PRINCIPAL_INVESTIGATOR, Radboud University Medical Center

Karen H. Lu, MD, PhD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Rosella P.M.G. Hermens, MD,PhD, PRINCIPAL_INVESTIGATOR, Radboud University Medical Center

Elizabeth M. Swisher, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

2040-02-17