RECRUITING

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

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Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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.

Quick Facts

Study Start:2020-03-01
Study Completion:2040-02-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04294927

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.

Ages Eligible for Study:25 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women with a class 5 (definitely pathogenic) BRCA1, BRCA2, RAD51C, RAD51D or BRIP1 germline mutation in one of the participating centers.
  2. * Age at inclusion;
  3. * BRCA1: 25-40 years
  4. * BRCA2: 25-45 years
  5. * RAD51C, RAD51D, BRIP1: 25-50 years
  6. * Childbearing completed
  7. * Presence of at least one fallopian tube
  8. * Participants may have a personal history of non-ovarian malignancy
  9. * Informed consent must be obtained and documented according to national and local regulatory requirements and the local rules followed in the institution.
  1. * Postmenopausal status (natural menopause or due to treatment)
  2. * Wish for second stage RRO within two years after RRS
  3. * Legally incapable
  4. * Prior bilateral salpingectomy
  5. * A personal history of ovarian, fallopian tube or peritoneal cancer
  6. * Current diagnosis or treatment for malignant disease

Contacts and Locations

Study Contact

Joanne A. de Hullu, MD, PhD
CONTACT
+31 (0) 24 36 16683
Joanne.deHullu@radboudumc.nl
Karen H. Lu, MD, PhD
CONTACT
(713) 745-8902
khlu@mdanderson.org

Principal Investigator

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 Locations (Sites)

Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
MD Anderson Cancer Centre
Houston, Texas, 77030-4009
United States
University of Washington
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: 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

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 Registration Dates

Study Start Date2020-03-01
Study Completion Date2040-02-17

Study Record Updates

Study Start Date2020-03-01
Study Completion Date2040-02-17

Terms related to this study

Additional Relevant MeSH Terms

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