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Purpose

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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1, RAD51C and/or RAD51D gene germline mutation. 2. Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2 and 30-50 years for BRIP1, RAD51C, RAD51D 3. Childbearing completed or no longer requires fallopian tubes 4. Presence of at least one fallopian tube 5. Participants may have a personal history of non-ovarian malignancy. 6. Informed consent must be obtained and documented.

Exclusion Criteria

  1. Postmenopausal status (natural menopause or due to (cancer) treatment) 2. Wish for second stage RRO within two years after RRS (if clear at enrollment) 3. Legally incapable 4. Prior bilateral salpingectomy 5. A personal history of ovarian, fallopian tube or peritoneal cancer 6. Current clinicals signs, diagnosis or treatment for malignant disease

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Risk-Reducing Salpingectomy-RRS 		Can help to lower the risk of ovarian cancer with a delayed removal of 1.
  • Other: RIsk-Reducing Salpingectomy (RRS)
    complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure
Other
Risk-Reducing Oophorectomy-RRO 		Can help to lower the risk of ovarian cancer removing both fallopian tubes.
  • Other: Risk-Reducing Oophorectomy-RRO
    complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure
Other
Risk-Reducing Salpingo-Oophorectomy-RRSO 		Can help to lower the risk of ovarian cancer as well as the standard-of-care risk-reducing procedure involving the removal of the fallopian tubes and ovaries (risk-reducing salpingo-oophorectomy-RRSO)
  • Other: Risk-Reducing Salpingo-Oophorectomy-RRSO
    complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure

Recruiting Locations

Harvard Cancer Center
Boston, Massachusetts 02215
Contact:
Colleen Feltmate, MD
617-732-8843
cfeltmate@bwh.harvard.edu

More Details

Status
Recruiting
Sponsor
M.D. Anderson Cancer Center

Study Contact

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

Detailed Description

The aim of the project is to evaluate RRS with delayed RRO as an alternative for RRSO in BRCA1/2 gene germline mutation carriers with respect to ovarian cancer incidence. We hypothesize that postponement of oophorectomy and consequent menopause to the age of 40-45 (BRCA1) or 45-50 (BRCA2) compared to current standard RRSO at age 35-40 (BRCA1) or 40-45 (BRCA2) will not lead to a significant increase in ovarian cancer risk. PRIMARY OBJECTIVE: To 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 in BRCA1/2 gene germline mutation carriers. SECONDARY OBJECTIVE: Incidence of (pre)malignant findings in tubes/ovaries, perioperative morbidity and mortality, incidence of non-ovarian pelvic cancer, breast cancer, prophylactic breast surgery and uptake of risk reducing oophorectomy. EXPLORATORY OBJECTIVE: Estimate high grade serous (ovarian) cancer incidence for innovative and standard treatments in BRIP1, RAD51C, and RAD51D gene germline mutation carriers

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.