RECRUITING

Risk Reducing Salpingectomy With Delayed Oophorectomy as an Alternative to Risk- Reducing Salpingo-oophorectomy in High Risk-Women to Assess the Safety of Prevention - US Cohort Study

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Conditions

Ovarian CancerFallopian Tube 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

This is a prospective preference study that will evaluate non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence

Official Title

Risk Reducing Salpingectomy With Delayed Oophorectomy as an Alternative to Risk- Reducing Salpingo-oophorectomy in High Risk-Women to Assess the Safety of Prevention - US Cohort Study

Quick Facts

Study Start:2022-05-10
Study Completion:2026-12-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05287451

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:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1, RAD51C and/or RAD51D gene germline mutation.
  2. 2. Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2 and 30-50 years for BRIP1, RAD51C, RAD51D
  3. 3. Childbearing completed or no longer requires fallopian tubes
  4. 4. Presence of at least one fallopian tube
  5. 5. Participants may have a personal history of non-ovarian malignancy.
  6. 6. Informed consent must be obtained and documented.
  1. 1. Postmenopausal status (natural menopause or due to (cancer) treatment)
  2. 2. Wish for second stage RRO within two years after RRS (if clear at enrollment)
  3. 3. Legally incapable
  4. 4. Prior bilateral salpingectomy
  5. 5. A personal history of ovarian, fallopian tube or peritoneal cancer
  6. 6. Current clinicals signs, diagnosis or treatment for malignant disease

Contacts and Locations

Study Contact

Roni Wilke, MD
CONTACT
(713) 822-4502
rnitecki@mdanderson.org

Principal Investigator

Roni Wilke, MD
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

Harvard Cancer Center
Boston, Massachusetts, 02215
United States
Washington University School of Medicine
Saint Louis, Missouri, 63130
United States
M D Anderson Cancer Center
Houston, Texas, 77030
United States
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Roni Wilke, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

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 Date2022-05-10
Study Completion Date2026-12-26

Study Record Updates

Study Start Date2022-05-10
Study Completion Date2026-12-26

Terms related to this study

Additional Relevant MeSH Terms

  • Ovarian Cancer
  • Fallopian Tube Cancer